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類別 法規性質 法規名稱 條文內容 發佈日期 附件檔案
1420509 查驗登記類,指示藥品審查基準,指示藥品審查基準-一般皮膚外用劑 行政解釋 指示藥品審查基準-一般皮膚外用劑 <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 16pt;">一般皮膚外用劑</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 14pt;">I</span><span style="font-family: 標楷體; font-size: 14pt;">、適用範圍</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 10.2pt 0pt 54.6pt;"><span style="font-size: 10pt;">A</span><span style="font-family: 標楷體; font-size: 10pt;">、凡皮膚外用製劑，載明有抗菌、局部消毒、滅蝨、抗發炎、止癢、止痛、緩解皮膚刺激、去角質、去疣或治療頭皮屑、色素變化、尋常性痤瘡及其他宣稱有療效的皮膚外用製劑均適用本基準。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 10.2pt 0pt 54.6pt;"><span style="font-size: 10pt;">B</span><span style="font-family: 標楷體; font-size: 10pt;">、凡含有生藥或中藥之製劑不適用本基準。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 14pt;">II</span><span style="font-family: 標楷體; font-size: 14pt;">、有效成分</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 10.2pt 0pt 54.6pt;"><span style="font-size: 10pt;">(A)</span><span style="font-family: 標楷體; font-size: 10pt;">有效成分之種類</span> </p><table style="margin: auto auto auto 45.35pt; border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <thead> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 35.3pt; padding-right: 0cm; padding-top: 0cm;border: windowtext 1pt solid;" colspan="2"> <p style="text-align: center; line-height: 15pt; margin: 3pt 5.65pt;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">主成分</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">最高含量</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">適應症</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">用法用量</span> </p> </td> </tr> </thead> <tbody> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 17.3pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="5"> <p style="text-align: center; line-height: 15pt; margin: 1pt 0cm;"><span style="font-family: 標楷體; font-size: 10pt;">抗</span><span style="font-size: 10pt;"><br /> <br /> &nbsp;<br /> </span><span style="font-family: 標楷體; font-size: 10pt;">生</span><span style="font-size: 10pt;"><br /> <br /> <br /> </span><span style="font-family: 標楷體; font-size: 10pt;">素</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 18pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 15pt; margin: 1pt 0cm;"><span style="font-size: 10pt;">A1</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Bacitracin</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">500unit/g</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">急救、預防及減緩皮膚刀傷、刮傷、燙傷之感染</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.4pt; font-size: 10pt;">2-4</span><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">次</span><span style="letter-spacing: -0.4pt; font-size: 10pt;">/</span><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">天，塗於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Polymycin B</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"><span style="font-size: 10pt;">10,000unit/g</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">急救、預防及減緩皮膚刀傷、刮傷、燙傷之感染</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.4pt; font-size: 10pt;">2-4</span><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">次</span><span style="letter-spacing: -0.4pt; font-size: 10pt;">/</span><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">天，塗於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Neomycin</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">3.5mg/g</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">急救、預防及減緩皮膚刀傷、刮傷、燙傷之感染</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.4pt; font-size: 10pt;">2-4</span><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">次</span><span style="letter-spacing: -0.4pt; font-size: 10pt;">/</span><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">天，塗於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 18pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 15pt; margin: 1pt 0cm;"><span style="font-size: 10pt;">A2</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Erythromycin</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 1.4pt 0pt;"><span style="font-size: 10pt;">1% </span><span style="font-family: 標楷體; font-size: 10pt;">軟膏</span><span style="font-size: 10pt;"><br /> <span style="letter-spacing: -0.2pt;">20mg/ml</span></span><span style="letter-spacing: -0.2pt; font-family: 標楷體; font-size: 10pt;">洗</span><span style="font-family: 標楷體; font-size: 10pt;">劑</span><span style="font-size: 10pt;"><br /> 2% w/v</span><span style="font-family: 標楷體; font-size: 10pt;">溶液</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">治療尋常性痤瘡</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.4pt; font-size: 10pt;">2-4</span><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">次</span><span style="letter-spacing: -0.4pt; font-size: 10pt;">/</span><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">天，塗於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Tetracycline Hydrochloride</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">30mg/g</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">急救、預防及減緩皮膚刀傷、刮傷、燙傷之感染</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.4pt; font-size: 10pt;">2-4</span><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">次</span><span style="letter-spacing: -0.4pt; font-size: 10pt;">/</span><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">天，塗於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 17.3pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="5"> <p style="text-align: center; line-height: 15pt; margin: 1pt 0cm;"><span style="font-family: 標楷體; font-size: 10pt;">抗</span><span style="font-size: 10pt;"><br /> <br /> <br /> </span><span style="font-family: 標楷體; font-size: 10pt;">黴</span><span style="font-size: 10pt;"><br /> <br /> <br /> </span><span style="font-family: 標楷體; font-size: 10pt;">菌</span><span style="font-size: 10pt;"><br /> <br /> <br /> </span><span style="font-family: 標楷體; font-size: 10pt;">劑</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 18pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 15pt; margin: 1pt 0cm;"><span style="font-size: 10pt;">B1</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Clotrimazole</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">1% w/w</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">治療皮膚表淺性黴菌感染，如：足癬（香港腳）、股癬、汗斑</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">2</span><span style="font-family: 標楷體; font-size: 10pt;">次</span><span style="font-size: 10pt;">/</span><span style="font-family: 標楷體; font-size: 10pt;">天，塗於患部，兒童不宜使用</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Ketoconazole</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">1% </span><span style="font-family: 標楷體; font-size: 10pt;">洗髮精</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">減少因黴菌感染所引起之頭皮屑治療之輔助劑</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.4pt; font-size: 10pt;">2</span><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">次</span><span style="letter-spacing: -0.4pt; font-size: 10pt;">/</span><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">週，</span><span style="letter-spacing: -0.4pt; font-size: 10pt;">2</span><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">次間隔至少三天，使用時間不超過四週</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="letter-spacing: -0.4pt; font-size: 10pt;">Miconazole Nitrat</span><span style="font-size: 10pt;">e</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">2%</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">治療皮膚表淺性黴菌感染，如：足癬（香港腳）、股癬、汗斑</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">一天</span><span style="font-size: 10pt;">2</span><span style="font-family: 標楷體; font-size: 10pt;">次</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 18pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 1pt 0cm;"><span style="font-size: 10pt;">B2</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Undecylenic Acid and Derivatives</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 1.4pt 0pt;"><span style="font-size: 10pt;">25% of undecylenic acid</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">治療皮膚表淺性黴菌感染，如：足癬（香港腳）、股癬</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">一天</span><span style="font-size: 10pt;">2</span><span style="font-family: 標楷體; font-size: 10pt;">次</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 18pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 1pt 0cm;"><span style="font-size: 10pt;">B3</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Tolnaftate</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">1%</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">治療皮膚表淺性黴菌感染，如：足癬（香港腳）、股癬、汗斑</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">一天</span><span style="font-size: 10pt;">2</span><span style="font-family: 標楷體; font-size: 10pt;">次</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 17.3pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 1pt 0cm;"><span style="font-family: 標楷體; font-size: 10pt;">滅</span><span style="font-size: 10pt;"><br /> <br /> </span><span style="font-family: 標楷體; font-size: 10pt;">蝨</span><span style="font-size: 10pt;"><br /> <br /> </span><span style="font-family: 標楷體; font-size: 10pt;">劑</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 18pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 1pt 0cm;"><span style="font-size: 10pt;">C</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Phenothrin</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">0.2% w/w</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">治療頭蝨、陰蝨</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">塗於乾燥毛髮之整個患部，使自然乾燥後</span><span style="letter-spacing: -0.4pt; font-size: 10pt;">2</span><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">小時洗淨再沖洗，並用細齒梳梳髮去掉蝨卵，必要時</span><span style="letter-spacing: -0.4pt; font-size: 10pt;">7-9</span><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">天後可重覆使用</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 17.3pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="4"> <p style="text-align: center; line-height: 15pt; margin: 1pt 0cm;"><span style="font-family: 標楷體; font-size: 10pt;">局</span><span style="font-size: 10pt;"><br /> <br /> </span><span style="font-family: 標楷體; font-size: 10pt;">部</span><span style="font-size: 10pt;"><br /> <br /> </span><span style="font-family: 標楷體; font-size: 10pt;">消</span><span style="font-size: 10pt;"><br /> <br /> </span><span style="font-family: 標楷體; font-size: 10pt;">毒</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 18pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="4"> <p style="text-align: center; line-height: 15pt; margin: 1pt 0cm;"><span style="font-size: 10pt;">D</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Chlorhexidine Gluconate</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">1.25% v/v<span style="text-decoration: underline;"></span></span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">一般外用消毒劑，可當作初步傷口處理</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">塗於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="letter-spacing: -0.4pt; font-size: 10pt;">Hydrogen Peroxid</span><span style="font-size: 10pt;">e</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">1.5% w/w<br /> Cream</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">傷口消毒</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">以棉球沾之塗於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">3% w/w<br /> Solution</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">傷口消毒</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">以棉球沾之塗於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Povidone-Iodine</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">1% </span><span style="font-family: 標楷體; font-size: 10pt;">有效碘</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">傷口消毒</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">以棉球沾之塗於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 17.3pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="12"> <p style="text-align: center; line-height: 15pt; margin: 1pt 0cm;"><span style="font-family: 標楷體; font-size: 10pt;">抗</span><span style="font-size: 10pt;"><br /> <br /> <br /> <br /> </span><span style="font-family: 標楷體; font-size: 10pt;">發</span><span style="font-size: 10pt;"><br /> <br /> <br /> <br /> </span><span style="font-family: 標楷體; font-size: 10pt;">炎</span><span style="font-size: 10pt;"><br /> <br /> <br /> <br /> </span><span style="font-family: 標楷體; font-size: 10pt;">劑</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 18pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="12"> <p style="text-align: center; line-height: 15pt; margin: 1pt 0cm;"><span style="font-size: 10pt;">E</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Betamethasone Dipropionate</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">0.02%<br /> Lotion</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.5pt; font-family: 標楷體; font-size: 10pt;">濕疹或皮膚</span><span style="font-family: 標楷體; font-size: 10pt;">炎</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">塗於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Betamethasone Valerate</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">0.10%<br /> Cream</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.5pt; font-family: 標楷體; font-size: 10pt;">濕疹或皮膚</span><span style="font-family: 標楷體; font-size: 10pt;">炎</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">塗於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Fluocinolone Acetonide</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">0.05%<br /> Cream</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.5pt; font-family: 標楷體; font-size: 10pt;">濕疹或皮膚</span><span style="font-family: 標楷體; font-size: 10pt;">炎</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">塗於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Hydrocortisone Butyrate</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">0.20%<br /> Cream</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.5pt; font-family: 標楷體; font-size: 10pt;">濕疹或皮膚</span><span style="font-family: 標楷體; font-size: 10pt;">炎</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">塗於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Hydrocortisone Valerate</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">0.10%<br /> Ointment</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.5pt; font-family: 標楷體; font-size: 10pt;">濕疹或皮膚</span><span style="font-family: 標楷體; font-size: 10pt;">炎</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">塗於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Triamcinolone Acetonide</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">0.10%<br /> Lotion</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.5pt; font-family: 標楷體; font-size: 10pt;">濕疹或皮膚</span><span style="font-family: 標楷體; font-size: 10pt;">炎</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">塗於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Betamethasone Valerate</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">0.05%<br /> Lotion</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.5pt; font-family: 標楷體; font-size: 10pt;">濕疹或皮膚</span><span style="font-family: 標楷體; font-size: 10pt;">炎</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">塗於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Desonide</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">0.05%<br /> Cream</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.5pt; font-family: 標楷體; font-size: 10pt;">濕疹或皮膚</span><span style="font-family: 標楷體; font-size: 10pt;">炎</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">塗於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Fluocinolone Acetonide</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">0.01%<br /> Soultion</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.5pt; font-family: 標楷體; font-size: 10pt;">濕疹或皮膚</span><span style="font-family: 標楷體; font-size: 10pt;">炎</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">塗於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Dexamethasone <span style="letter-spacing: -0.2pt;">Sodium phosphat</span>e</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">0.05%<br /> Cream</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.5pt; font-family: 標楷體; font-size: 10pt;">濕疹或皮膚</span><span style="font-family: 標楷體; font-size: 10pt;">炎</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">塗於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Hydrocortisone Acetate</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">1%</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.5pt; font-family: 標楷體; font-size: 10pt;">濕疹或皮膚</span><span style="font-family: 標楷體; font-size: 10pt;">炎</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">塗於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="letter-spacing: -0.5pt; font-size: 10pt;">Methylprednisolon</span><span style="font-size: 10pt;">e Acetate</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">0.25%<br /> Ointment</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.5pt; font-family: 標楷體; font-size: 10pt;">濕疹或皮膚</span><span style="font-family: 標楷體; font-size: 10pt;">炎</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">塗於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 69.9pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 17.3pt; padding-right: 0cm; height: 69.9pt; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 15pt; margin: 1pt 0cm;"><span style="font-family: 標楷體; font-size: 10pt;">止</span><span style="font-size: 10pt;"><br /> </span><span style="font-family: 標楷體; font-size: 10pt;">癢</span><span style="font-size: 10pt;"><br /> </span><span style="font-family: 標楷體; font-size: 10pt;">劑</span><span style="font-size: 10pt;"><br /> </span><span style="font-family: 標楷體; font-size: 10pt;">及</span><span style="font-size: 10pt;"><br /> </span><span style="font-family: 標楷體; font-size: 10pt;">局</span><span style="font-size: 10pt;"><br /> </span><span style="font-family: 標楷體; font-size: 10pt;">部</span><span style="font-size: 10pt;"><br /> </span><span style="font-family: 標楷體; font-size: 10pt;">麻</span><span style="font-size: 10pt;"><br /> </span><span style="font-family: 標楷體; font-size: 10pt;">醉</span><span style="font-size: 10pt;"><br /> </span><span style="font-family: 標楷體; font-size: 10pt;">劑</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 18pt; padding-right: 0cm; height: 69.9pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 1pt 0cm;"><span style="font-size: 10pt;">F1</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; height: 69.9pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Diphenhydramine Hydrochloride</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; height: 69.9pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">2%</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; height: 69.9pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">暫時緩解皮膚搔癢</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; height: 69.9pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">3-4</span><span style="font-family: 標楷體; font-size: 10pt;">次</span><span style="font-size: 10pt;">/</span><span style="font-family: 標楷體; font-size: 10pt;">天，塗於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 69.9pt;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 18pt; padding-right: 0cm; height: 69.9pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 1pt 0cm;"><span style="font-size: 10pt;">F2</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; height: 69.9pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Dibucaine</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; height: 69.9pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">1%</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; height: 69.9pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">昆蟲咬傷或皮膚刺激所引起之疼痛及搔癢</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; height: 69.9pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">3-4</span><span style="font-family: 標楷體; font-size: 10pt;">次</span><span style="font-size: 10pt;">/</span><span style="font-family: 標楷體; font-size: 10pt;">天，塗於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 17.3pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="5"> <p style="text-align: center; line-height: 15pt; margin: 1pt 0cm;"><span style="font-family: 標楷體; font-size: 10pt;">其</span><span style="font-size: 10pt;"><br /> <br /> <br /> <br /> <br /> <br /> </span><span style="font-family: 標楷體; font-size: 10pt;">他</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 18pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 15pt; margin: 1pt 0cm;"><span style="font-size: 10pt;">G</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Urea</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">10%</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">去角質</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">1-2</span><span style="font-family: 標楷體; font-size: 10pt;">次</span><span style="font-size: 10pt;">/</span><span style="font-family: 標楷體; font-size: 10pt;">天，塗於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Zinc Oxide</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">10%</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">緩解皮膚刺激及尿布疹</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">需要時使用，塗於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 18pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 15pt; margin: 1pt 0cm;"><span style="font-size: 10pt;">H</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Benzoyl Peroxide</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">10%</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">治療尋常性痤瘡</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">1</span><span style="font-family: 標楷體; font-size: 10pt;">次</span><span style="font-size: 10pt;">/</span><span style="font-family: 標楷體; font-size: 10pt;">天，塗於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">Capsaicin</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">0.025%</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">暫時緩解局部疼痛</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">不超過</span><span style="font-size: 10pt;">4</span><span style="font-family: 標楷體; font-size: 10pt;">次</span><span style="font-size: 10pt;">/</span><span style="font-family: 標楷體; font-size: 10pt;">天</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">Hydroquinone</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">1%</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">減輕黑斑、雀斑或其他色素沉著</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 2.85pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">早晚各塗敷</span><span style="font-size: 10pt;">1</span><span style="font-family: 標楷體; font-size: 10pt;">次</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 17.3pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="4"> <p style="text-align: center; line-height: 15pt; margin: 1pt 0cm;"><span style="font-family: 標楷體; font-size: 10pt;">其</span><span style="font-size: 10pt;"><br /> <br /> <br /> <br /> <br /> <br /> <br /> <br /> </span><span style="font-family: 標楷體; font-size: 10pt;">他</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 18pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 15pt; margin: 1pt 0cm;"><span style="font-size: 10pt;">H</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Selenium Sulfide<br /> <span style="letter-spacing: -0.8pt;">(</span></span><span style="letter-spacing: -0.8pt; font-family: 標楷體; font-size: 10pt;">＝</span><span style="letter-spacing: -0.8pt; font-size: 10pt;">Selenium Disulfied</span><span style="font-size: 10pt;">)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">1%</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">頭皮屑</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">一般使用方法：前二星期，每週</span><span style="letter-spacing: -0.4pt; font-size: 10pt;">2</span><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">次，後每星期</span><span style="letter-spacing: -0.4pt; font-size: 10pt;">1</span><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">次或二星期</span><span style="letter-spacing: -0.4pt; font-size: 10pt;">1</span><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">次，塗於患部。</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">Pyrithione Zinc</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">2%</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">頭皮屑</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">一般使用方法：前二星期，每週</span><span style="letter-spacing: -0.4pt; font-size: 10pt;">2</span><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">次，後每星期</span><span style="letter-spacing: -0.4pt; font-size: 10pt;">1</span><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">次或二星期</span><span style="letter-spacing: -0.4pt; font-size: 10pt;">1</span><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">次，塗於患部。</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 18pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 15pt; margin: 1pt 0cm;"><span style="font-size: 10pt;">I</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">Salicylic Acid</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">2%</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">去角質</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">1-2</span><span style="font-family: 標楷體; font-size: 10pt;">次</span><span style="font-size: 10pt;">/</span><span style="font-family: 標楷體; font-size: 10pt;">天，塗於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">17%</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">治療疣</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">1</span><span style="font-family: 標楷體; font-size: 10pt;">次</span><span style="font-size: 10pt;">/</span><span style="font-family: 標楷體; font-size: 10pt;">天，塗於患部</span> </p> </td> </tr> </tbody></table><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 10.2pt 0pt 54.6pt;"><span style="font-size: 10pt;">(B)</span><span style="font-family: 標楷體; font-size: 10pt;">複合配方</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">1</span><span style="font-family: 標楷體; font-size: 10pt;">、抗生素類：</span><span style="font-size: 10pt;">A1</span><span style="font-family: 標楷體; font-size: 10pt;">不超過</span><span style="font-size: 10pt;">3</span><span style="font-family: 標楷體; font-size: 10pt;">種。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">A2</span><span style="font-family: 標楷體; font-size: 10pt;">須單獨存在。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">2</span><span style="font-family: 標楷體; font-size: 10pt;">、任意抗生素（</span><span style="font-size: 10pt;">A1</span><span style="font-family: 標楷體; font-size: 10pt;">）＋抗發炎劑（</span><span style="font-size: 10pt;">E</span><span style="font-family: 標楷體; font-size: 10pt;">）只能各含</span><span style="font-size: 10pt;">1</span><span style="font-family: 標楷體; font-size: 10pt;">種。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">3</span><span style="font-family: 標楷體; font-size: 10pt;">、其他類之（</span><span style="font-size: 10pt;">G</span><span style="font-family: 標楷體; font-size: 10pt;">）可與任何種類配合。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">4</span><span style="font-family: 標楷體; font-size: 10pt;">、</span><span style="font-size: 10pt;">C</span><span style="font-family: 標楷體; font-size: 10pt;">（滅蝨）、</span><span style="font-size: 10pt;">D</span><span style="font-family: 標楷體; font-size: 10pt;">（局部抗感染劑）須單獨存在。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">5</span><span style="font-family: 標楷體; font-size: 10pt;">、</span><span style="font-size: 10pt;">Steroid</span><span style="font-family: 標楷體; font-size: 10pt;">只能含</span><span style="font-size: 10pt;">1</span><span style="font-family: 標楷體; font-size: 10pt;">種，止癢劑及局部麻醉劑可含</span><span style="font-size: 10pt;">1-2</span><span style="font-family: 標楷體; font-size: 10pt;">種。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">6</span><span style="font-family: 標楷體; font-size: 10pt;">、其他類之（</span><span style="font-size: 10pt;">I</span><span style="font-family: 標楷體; font-size: 10pt;">）可與（</span><span style="font-size: 10pt;">G</span><span style="font-family: 標楷體; font-size: 10pt;">）、抗發炎劑（</span><span style="font-size: 10pt;">E</span><span style="font-family: 標楷體; font-size: 10pt;">）、抗黴菌劑（</span><span style="font-size: 10pt;">B</span><span style="font-family: 標楷體; font-size: 10pt;">）各</span><span style="font-size: 10pt;">1</span><span style="font-family: 標楷體; font-size: 10pt;">種配合。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">7</span><span style="font-family: 標楷體; font-size: 10pt;">、抗生素（</span><span style="font-size: 10pt;">A1</span><span style="font-family: 標楷體; font-size: 10pt;">）</span><span style="font-size: 10pt;">1</span><span style="font-family: 標楷體; font-size: 10pt;">種＋抗發炎劑（</span><span style="font-size: 10pt;">E</span><span style="font-family: 標楷體; font-size: 10pt;">）</span><span style="font-size: 10pt;">1</span><span style="font-family: 標楷體; font-size: 10pt;">種＋其他類之（</span><span style="font-size: 10pt;">G</span><span style="font-family: 標楷體; font-size: 10pt;">）可配合。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">8</span><span style="font-family: 標楷體; font-size: 10pt;">、抗發炎劑（</span><span style="font-size: 10pt;">E</span><span style="font-family: 標楷體; font-size: 10pt;">）</span><span style="font-size: 10pt;">1</span><span style="font-family: 標楷體; font-size: 10pt;">種＋止癢劑及局部麻醉劑（</span><span style="font-size: 10pt;">F</span><span style="font-family: 標楷體; font-size: 10pt;">）可含</span><span style="font-size: 10pt;">1-2</span><span style="font-family: 標楷體; font-size: 10pt;">種＋其他類之（</span><span style="font-size: 10pt;">G</span><span style="font-family: 標楷體; font-size: 10pt;">）可配合。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 14pt;">III</span><span style="font-family: 標楷體; font-size: 14pt;">、劑型</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">A</span><span style="font-family: 標楷體; font-size: 10pt;">、包括：</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-family: 標楷體; font-size: 10pt;">乳膏（</span><span style="font-size: 10pt;">Cream</span><span style="font-family: 標楷體; font-size: 10pt;">）、軟膏（</span><span style="font-size: 10pt;">Ointment</span><span style="font-family: 標楷體; font-size: 10pt;">）、凝膠（</span><span style="font-size: 10pt;">Gel</span><span style="font-family: 標楷體; font-size: 10pt;">）、洗劑（</span><span style="font-size: 10pt;">Lotion</span><span style="font-family: 標楷體; font-size: 10pt;">）、溶液（</span><span style="font-size: 10pt;">Solution</span><span style="font-family: 標楷體; font-size: 10pt;">）、貼布（</span><span style="font-size: 10pt;">Patch</span><span style="font-family: 標楷體; font-size: 10pt;">）、粉劑（</span><span style="font-size: 10pt;">Powder</span><span style="font-family: 標楷體; font-size: 10pt;">）。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">B</span><span style="font-family: 標楷體; font-size: 10pt;">、如在成分表中列有劑型者，只能以表中之劑型存在。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 14pt;">IV</span><span style="font-family: 標楷體; font-size: 14pt;">、副作用</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-family: 標楷體; font-size: 10pt;">抗生素：</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">1</span><span style="font-family: 標楷體; font-size: 10pt;">、過敏性皮膚炎。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">2</span><span style="font-family: 標楷體; font-size: 10pt;">、繼發性感染。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">3</span><span style="font-family: 標楷體; font-size: 10pt;">、</span><span style="font-size: 10pt;">Neomycin</span><span style="font-family: 標楷體; font-size: 10pt;">：耳及腎毒性。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-family: 標楷體; font-size: 10pt;">抗黴菌劑：</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">1</span><span style="font-family: 標楷體; font-size: 10pt;">、局部皮膚刺激及灼熱感。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">2</span><span style="font-family: 標楷體; font-size: 10pt;">、過敏性皮膚炎。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">3</span><span style="font-family: 標楷體; font-size: 10pt;">、紅、腫、水泡、脫皮、搔癢等。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">Phenothrin</span><span style="font-family: 標楷體; font-size: 10pt;">：偶有過敏反應。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">Selenium</span><span style="font-family: 標楷體; font-size: 10pt;">：</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">1</span><span style="font-family: 標楷體; font-size: 10pt;">、局部刺激感、脫髮、頭髮褪色。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">2</span><span style="font-family: 標楷體; font-size: 10pt;">、頭髮、頭皮會有出油或乾澀之現象。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">Chlorhexidine</span><span style="font-family: 標楷體; font-size: 10pt;">：刺激感、皮膚炎、過敏性反應。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">Pyrithione Zinc</span><span style="font-family: 標楷體; font-size: 10pt;">：偶有接觸性皮膚炎。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-family: 標楷體; font-size: 10pt;">類固醇：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 112.6pt;"><span style="font-size: 10pt;">(A)</span><span style="font-family: 標楷體; font-size: 10pt;">局部性：搔癢、刺痛、紅斑、皮膚感染、毛囊炎、青春痘、皮膚濕軟、繼發性感染、多毛症、皮膚萎縮、痱子、毛細管擴張。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 112.6pt;"><span style="font-size: 10pt;">(B)</span><span style="font-family: 標楷體; font-size: 10pt;">全身性：庫欣式症候群（</span><span style="font-size: 10pt;">Cushing's syndrome</span><span style="font-family: 標楷體; font-size: 10pt;">，如滿月臉、體重增加、疲倦、高血壓、多毛症、月經異常、人格異常、水腫、多尿、多渴等）、繼發性腎上腺功能不足（</span><span style="font-size: 10pt;">secondary adrenal insufficiency</span><span style="font-family: 標楷體; font-size: 10pt;">，如疲倦、無力、噁心嘔吐、食慾不振、體重減輕、低血壓、腹痛、便秘或腹瀉等）。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">Dibucaine</span><span style="font-family: 標楷體; font-size: 10pt;">：局部灼熱、刺痛、偶有過敏性反應。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">Benzoyl Peroxide</span><span style="font-family: 標楷體; font-size: 10pt;">：過敏性皮膚炎，過度的皮膚乾燥，脫皮、刺痛。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">Salicylic Acid</span><span style="font-family: 標楷體; font-size: 10pt;">：紅斑、搔癢、刺痛感、水楊酸反應（耳鳴、暈眩、噁心、嘔吐等）。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">Capsaicin</span><span style="font-family: 標楷體; font-size: 10pt;">：皮膚灼熱感、刺痛、紅斑、嗆鼻、刺激性咳嗽。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">Hydroquinone</span><span style="font-family: 標楷體; font-size: 10pt;">：局部紅斑、刺痛、過敏性皮膚炎。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 14pt;">V</span><span style="font-family: 標楷體; font-size: 14pt;">、注意事項：</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">1</span><span style="font-family: 標楷體; font-size: 10pt;">、須置於小孩接觸不到之處。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">2</span><span style="font-family: 標楷體; font-size: 10pt;">、避免陽光直射，宜保存於陰涼之處。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">3</span><span style="font-family: 標楷體; font-size: 10pt;">、除非藥師、藥劑生或醫師指示，兒童、孕婦及授乳婦不建議自行使用。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">4</span><span style="font-family: 標楷體; font-size: 10pt;">、勿超過建議劑量，若有副作用產生，應立即停藥就醫。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 62.35pt;"><span style="font-size: 10pt;">5</span><span style="font-family: 標楷體; font-size: 10pt;">、除非藥師、藥劑生或醫師指示，本製劑限於皮膚外用不得內服，或使用於眼睛內，亦不得施於眼睛四周或黏膜。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 62.35pt;"><span style="font-size: 10pt;">6</span><span style="font-family: 標楷體; font-size: 10pt;">、除非有藥師、藥劑生或醫師指示，本製劑勿使用於大面積之體表或皮膚深部感染。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 62.35pt;"><span style="font-size: 10pt;">7</span><span style="font-family: 標楷體; font-size: 10pt;">、使用後自覺狀況未改善或更惡化，應立即停藥並就醫。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 62.35pt;"><span style="font-size: 10pt;">8</span><span style="font-family: 標楷體; font-size: 10pt;">、除非藥師、藥劑生或醫師指示，使用皮膚外用藥後請勿覆蓋，以免增加副作用。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 62.35pt;"><span style="font-size: 10pt;">9</span><span style="font-family: 標楷體; font-size: 10pt;">、塗抹皮膚外用藥後應徹底洗淨雙手後，再戴隱形眼鏡。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 62.35pt;"><span style="font-size: 10pt;">10</span><span style="font-family: 標楷體; font-size: 10pt;">、深部皮膚組織感染請就醫治療。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 62.35pt;"><span style="font-size: 10pt;">11</span><span style="font-family: 標楷體; font-size: 10pt;">、黴菌治療至少二星期，使用此藥須完成全程療程。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 67.85pt;"><span style="font-size: 10pt;">12</span><span style="font-family: 標楷體; font-size: 10pt;">、一般黴菌治療一星期症狀會改善，股癬和體癬經二星期，足癬經四星期治療症狀若沒有改善應停藥立即就醫，即使若症狀有改善停藥後若病情複發應停藥立即就醫。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 67.85pt;"><span style="font-size: 10pt;">13</span><span style="font-family: 標楷體; font-size: 10pt;">、除非藥師、藥劑生或醫師指示，類固醇抗發炎劑不可連續使用超過二星期。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 67.85pt;"><span style="font-size: 10pt;">14</span><span style="font-family: 標楷體; font-size: 10pt;">、使用</span><span style="font-size: 10pt;"> Benzoyl Peroxide </span><span style="font-family: 標楷體; font-size: 10pt;">避免與其他皮膚刺激原（如陽光）接觸，塗抹部位應避免陽光曝曬。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 14pt;">VI</span><span style="font-family: 標楷體; font-size: 14pt;">、警語</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-family: 標楷體; font-size: 10pt;">抗生素：</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">1</span><span style="font-family: 標楷體; font-size: 10pt;">、對藥物各成分過敏者不得使用。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">2</span><span style="font-family: 標楷體; font-size: 10pt;">、長期使用有可能引起繼發性感染。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">3</span><span style="font-family: 標楷體; font-size: 10pt;">、會使衣物染色。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-family: 標楷體; font-size: 10pt;">抗黴菌劑：</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-family: 標楷體; font-size: 10pt;">對藥物各成分過敏者不得使用。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-family: 標楷體; font-size: 10pt;">局部消毒劑：</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">Chlorhexidine</span><span style="font-family: 標楷體; font-size: 10pt;">：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">1</span><span style="font-family: 標楷體; font-size: 10pt;">、對藥物各成分過敏者不得使用。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">2</span><span style="font-family: 標楷體; font-size: 10pt;">、使用前應依仿單規定稀釋，以免灼燒皮膚。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">3</span><span style="font-family: 標楷體; font-size: 10pt;">、避免接觸外耳道，尤其耳膜破裂時進入中耳，有造成耳聾之虞。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">Povidone Iodine</span><span style="font-family: 標楷體; font-size: 10pt;">：</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">1</span><span style="font-family: 標楷體; font-size: 10pt;">、對藥物各成分過敏者不得使用。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">2</span><span style="font-family: 標楷體; font-size: 10pt;">、碘過敏者不能使用。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">3</span><span style="font-family: 標楷體; font-size: 10pt;">、有全身性吸收之可能性，因此反覆使用新生兒可能出現甲狀腺功能低下，孕婦及其胎兒及授乳婦有造成甲狀腺腫及甲狀腺功能低下。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">4</span><span style="font-family: 標楷體; font-size: 10pt;">、會使皮膚或衣物染色。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-family: 標楷體; font-size: 10pt;">類固醇：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">1</span><span style="font-family: 標楷體; font-size: 10pt;">、對藥物各成分過敏者不得使用。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">2</span><span style="font-family: 標楷體; font-size: 10pt;">、小孩長期使用較易引起庫欣氏症候群及腎上腺功能障礙。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">3</span><span style="font-family: 標楷體; font-size: 10pt;">、癬類或其他皮膚感染症，應使用抗感染劑，單獨使用類固醇會使病情惡化。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">4</span><span style="font-family: 標楷體; font-size: 10pt;">、臉部、腋部及鼠蹊部，若長期使用類固醇容易出現局部皮膚萎縮。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">5</span><span style="font-family: 標楷體; font-size: 10pt;">、皮膚的黴菌感染有時不易與其他皮膚炎區分，誤用類固醇會使病情惡化並造成日後診斷及治療之困難。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-family: 標楷體; font-size: 10pt;">其他類：</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">Selenium</span><span style="font-family: 標楷體; font-size: 10pt;">：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">1</span><span style="font-family: 標楷體; font-size: 10pt;">、對藥物各成分過敏者不得使用。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">2</span><span style="font-family: 標楷體; font-size: 10pt;">、皮膚頭皮有急性發炎時勿使用。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">3</span><span style="font-family: 標楷體; font-size: 10pt;">、可能傷及珠寶，使用前先除去、治療後充分沖洗。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">4</span><span style="font-family: 標楷體; font-size: 10pt;">、不應長期使用，長期使用會脫髮。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">Diphenhydramine HCl</span><span style="font-family: 標楷體; font-size: 10pt;">：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">1</span><span style="font-family: 標楷體; font-size: 10pt;">、對藥物各成分過敏者不得使用。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">2</span><span style="font-family: 標楷體; font-size: 10pt;">、連續使用超過三星期時有增加過敏性接觸性皮膚炎之虞。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">Dibucaine</span><span style="font-family: 標楷體; font-size: 10pt;">：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">1</span><span style="font-family: 標楷體; font-size: 10pt;">、對藥物各成分過敏者不得使用。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">2</span><span style="font-family: 標楷體; font-size: 10pt;">、不得大量使用，以避免全身性吸收，曾有致死報告。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">Benzoyl Peroxide</span><span style="font-family: 標楷體; font-size: 10pt;">：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">1</span><span style="font-family: 標楷體; font-size: 10pt;">、對藥物各成分過敏者不得使用。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">2</span><span style="font-family: 標楷體; font-size: 10pt;">、不要觸碰眼皮、唇部黏膜及發炎的皮膚。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">3</span><span style="font-family: 標楷體; font-size: 10pt;">、為一種氧化劑會使頭髮褪色、使衣物染色。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">Salicylic acid</span><span style="font-family: 標楷體; font-size: 10pt;">：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">1</span><span style="font-family: 標楷體; font-size: 10pt;">、對藥物各成分過敏者不得使用。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">2</span><span style="font-family: 標楷體; font-size: 10pt;">、大範圍及長期使用會造成水楊酸效應（耳鳴、暈眩、噁心、嘔吐等）。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">3</span><span style="font-family: 標楷體; font-size: 10pt;">、避免觸碰衣物、塑膠品、木材、金屬。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">4</span><span style="font-family: 標楷體; font-size: 10pt;">、不要觸碰眼部、臉部、陰部、黏膜。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">Hydroquinone</span><span style="font-family: 標楷體; font-size: 10pt;">：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">1</span><span style="font-family: 標楷體; font-size: 10pt;">、對藥物各成分過敏者不得使用。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">2</span><span style="font-family: 標楷體; font-size: 10pt;">、有局部皮膚過敏之危險，第一次使用應以小量開始，觀察</span><span style="font-size: 10pt;">24</span><span style="font-family: 標楷體; font-size: 10pt;">小時有無不良反應，若出現水泡、皮膚搔癢、紅、腫應停止使用。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">Pyrithione Zinc</span><span style="font-family: 標楷體; font-size: 10pt;">：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">1</span><span style="font-family: 標楷體; font-size: 10pt;">、對藥物各成分過敏者不得使用。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">2</span><span style="font-family: 標楷體; font-size: 10pt;">、頭皮或皮膚有破皮或發炎者請勿使用。</span> </p> 2013-12-04
1420510 查驗登記類,指示藥品審查基準,胃腸製劑 行政解釋 指示藥品審查基準-胃腸製劑 詳如附件 2013-12-04 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4510&type=0
1420511 查驗登記類,指示藥品審查基準,眼用製劑 行政解釋 指示藥品審查基準-眼用製劑 <div style="layout-grid: 16.3pt none;" class="WordSection1"><p style="text-justify: distribute-all-lines; text-align: justify; margin: 0cm 5cm 30pt;"><span style="font-family: 標楷體; font-size: 28pt;">眼用製劑</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 41.95pt;"><span style="font-size: 18pt;">I、</span><span style="font-family: 標楷體; font-size: 18pt;">適用範圍</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 70.9pt;"><span style="font-family: 標楷體; font-size: 14pt;">(一)</span><span style="font-family: 標楷體; font-size: 14pt;">凡是<b>施用於眼睛</b>治療眼部疾病，包括：因輕微眼部刺激所引起之不適或眼睛紅、眼睛疲勞、<b>眼睛癢</b>，因眼睛乾澀所引起灼熱感與刺激感<b>或用於沖洗眼部</b>的藥劑，均適用本基準。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 24pt 70.9pt;"><span style="font-family: 標楷體; font-size: 14pt;">(二)</span><span style="font-family: 標楷體; font-size: 14pt;">隱型眼鏡藥水，不適用本基準。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 21pt 12pt 41.95pt;"><span style="font-size: 18pt;">II、</span><span style="font-family: 標楷體; font-size: 18pt;">有效成分</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 21pt 9pt 70.9pt;"><span style="font-family: 標楷體; font-size: 14pt;">(一)</span><span style="font-family: 標楷體; font-size: 14pt;">有效成分之種類及含量：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 21pt 9pt 89.6pt;"><span style="font-size: 14pt;">(A)</span><span style="font-family: 標楷體; font-size: 14pt;">本基準可配合之有效成分，記載於表一。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 21pt 9pt 89.6pt;"><span style="font-size: 14pt;">(B)</span><span style="font-family: 標楷體; font-size: 14pt;">表一中，除</span><span style="font-size: 14pt;">G</span><span style="font-family: 標楷體; font-size: 14pt;">欄外，規定各品項可配合之最高含量。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 21pt 9pt 89.6pt;"><span style="font-size: 14pt;">(C)</span><span style="font-family: 標楷體; font-size: 14pt;">表一中，規定各欄之適應症。</span> </p><p style="line-height: 20pt; margin: 0cm 0cm 6pt 72pt;"><span style="font-family: 標楷體; font-size: 14pt;">表一、有效成分種類</span> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="margin: 3pt 0cm; padding-top: 1pt;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-top: windowtext 1.5pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-family: 標楷體; font-size: 14pt;">欄 </span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1.5pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-family: 標楷體; font-size: 14pt;">項 </span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1.5pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; margin: 3pt 42.55pt; padding-top: 1pt;"><span style="font-family: 標楷體; font-size: 14pt;">有效成分 </span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1.5pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 3pt 5.65pt;"><span style="font-family: 標楷體; font-size: 14pt;">最高含量(%)</span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 95.5pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1.5pt solid; border-right: windowtext 1.5pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; margin: 3pt 22.7pt; padding-top: 1pt;"><span style="font-family: 標楷體; font-size: 14pt;">適應症 </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; margin: 0.5pt 0cm; padding-top: 1pt;">&nbsp;</p> </td> <td style="border-bottom-color: #f0f0f0; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="12"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-size: 14pt;">A</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="4"> <p style="text-align: center; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-size: 14pt;">1</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1pt 5.65pt;">Ephedrine hydrochloride</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 5.65pt;"><span>0.123<br /> (</span><span style="font-family: 標楷體;">單一濃度</span>)</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 95.5pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1.5pt solid; padding-top: 0cm;" rowspan="12"> <p style="text-justify: inter-ideograph; text-align: justify; margin: 1pt 5.65pt; padding-top: 1pt;"><span style="font-family: 標楷體; font-size: 14pt;">暫時緩解因輕微眼部刺激所引起之不適、或眼睛紅</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="margin: 0.5pt 0cm; padding-top: 1pt;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1pt 5.65pt;">Naphazoline hydrochloride</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 5.65pt;"><b>0.01</b> - 0.03</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="margin: 0.5pt 0cm; padding-top: 1pt;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1pt 5.65pt;">Phenylephrine hydrochloride</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 5.65pt;">0.08 - 0.20</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="margin: 0.5pt 0cm; padding-top: 1pt;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1pt 5.65pt;">Tetrahydrozoline hydrochloride</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 5.65pt;">0.01 - 0.05</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; margin: 0.5pt 0cm; padding-top: 1pt;">&nbsp;</p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="8"> <p style="text-align: center; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-size: 14pt;">2</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;">Ephedrine hydrochloride</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>0.1</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="margin: 0.5pt 0cm; padding-top: 1pt;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;">Naphazoline hydrochloride </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>0.003</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="margin: 0.5pt 0cm; padding-top: 1pt;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;">Phenylephrine hydrochloride</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>0.1</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="margin: 0.5pt 0cm; padding-top: 1pt;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;">Tetrahydrozoline hydrochloride</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>0.05</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="margin: 0.5pt 0cm; padding-top: 1pt;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>Epinephrine</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>0.003</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="margin: 0.5pt 0cm; padding-top: 1pt;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1pt 5.65pt; padding-top: 1pt;"><b><span>Epinephrine hydrochloride <sup>*</sup></span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 1.4pt; padding-top: 1pt;"><b><span>0.003<br /> <span style="letter-spacing: -0.2pt;">(as Epinephrine</span>)</span></b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="margin: 0.5pt 0cm; padding-top: 1pt;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>Naphazoline nitrate</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>0.003</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="margin: 0.5pt 0cm; padding-top: 1pt;">&nbsp;</p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1pt 0cm 1pt 5.65pt; padding-top: 1pt;"><b><span style="letter-spacing: -0.1pt;">dl-Methylephedrine hydrochlorid</span></b><b>e</b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>0.1</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="margin: 0.5pt 0cm; padding-top: 1pt;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1.5pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-size: 14pt;">B</span></p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 0cm 1.4pt 0pt; padding-top: 1pt;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>Neostigmine methylsulfate</b></p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 5.65pt; padding-top: 1pt;"><b>0.005</b></p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 95.5pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; margin: 1pt 5.65pt;">&nbsp;</p> </td> </tr> </tbody></table><p style="page-break-before: always; line-height: 20pt; margin: 0cm 0cm 6pt 72pt;"><span style="font-family: 標楷體; font-size: 14pt;">表一、有效成分種類（續）</span> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="margin: 3pt 0cm; padding-top: 1pt;">&nbsp;</p> </td> <td style="border-bottom-color: #f0f0f0; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-top: windowtext 1.5pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-family: 標楷體; font-size: 14pt;">欄 </span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1.5pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-family: 標楷體; font-size: 14pt;">項 </span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1.5pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; margin: 3pt 42.55pt; padding-top: 1pt;"><span style="font-family: 標楷體; font-size: 14pt;">有效成分 </span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1.5pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 3pt 5.65pt;"><span style="font-family: 標楷體; font-size: 14pt;">最高含量(%)</span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 95.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1.5pt solid; border-right: windowtext 1.5pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; margin: 3pt 22.7pt; padding-top: 1pt;"><span style="font-family: 標楷體; font-size: 14pt;">適應症 </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="margin: 0.5pt 0cm; padding-top: 1pt;">&nbsp;</p> </td> <td style="border-bottom-color: #f0f0f0; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="9"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-size: 14pt;">C</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-size: 14pt;">1</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b><span style="font-family: 標楷體;">&epsilon;</span></b><b>-Aminocaproic acid</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>5</b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 95.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1.5pt solid; padding-top: 0cm;" rowspan="9"> <p style="text-justify: inter-ideograph; text-align: justify; margin: 1pt 5.65pt; padding-top: 1pt;"><span style="font-family: 標楷體; font-size: 14pt;">暫時緩解因輕微眼部刺激所引起之不適</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="margin: 0.5pt 0cm; padding-top: 1pt;">&nbsp;</p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-size: 14pt;">2</span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>Allantoin</b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>0.3</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;" rowspan="2"> <p style="margin: 0.5pt 0cm; padding-top: 1pt;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-size: 14pt;">3</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>Berberine hydrochloride</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>0.025</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>Berberine sulfate</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>0.025</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="margin: 0.5pt 0cm; padding-top: 1pt;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-size: 14pt;">4</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>Sodium azulene sulfonate</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>0.02</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="margin: 0.5pt 0cm; padding-top: 1pt;">&nbsp;</p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-size: 14pt;">5</span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>Dipotassium glycyrrhizinate</b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>0.25</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;" rowspan="2"> <p style="margin: 0.5pt 0cm; padding-top: 1pt;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-size: 14pt;">6</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;">Zinc sulfate</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;">0.25</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>Zinc lactate</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>0.25</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="margin: 0.5pt 0cm; padding-top: 1pt;">&nbsp;</p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-size: 14pt;">7</span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>Lysozyme chloride</b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>0.5 (</b><b><span style="font-family: 標楷體;">力價</span></b><b>)</b></p> </td> </tr> <tr style="page-break-inside: avoid; height: 55.1pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; height: 55.1pt; padding-top: 0cm;border-color: #f0f0f0;"> <p style="margin: 1pt 0cm; padding-top: 1pt;">&nbsp;</p> </td> <td style="border-bottom-color: #f0f0f0; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; height: 55.1pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 1.4pt; padding-top: 1pt;"><span style="font-size: 14pt;">D</span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; height: 55.1pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; margin: 0cm 1.4pt 0pt; padding-top: 1pt;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; height: 55.1pt; border-right-color: #f0f0f0; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>Diphenhydramine hydrochloride</b></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; height: 55.1pt; padding-top: 0cm;border: windowtext 1pt solid;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>0.05</b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 95.65pt; padding-right: 0cm; height: 55.1pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1.5pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; margin: 1pt 5.65pt; padding-top: 1pt;"><b><span style="font-family: 標楷體; font-size: 14pt;">眼睛癢</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid; height: 55.15pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; height: 55.15pt; padding-top: 0cm;border-color: #f0f0f0;"> <p style="margin: 1pt 0cm; padding-top: 1pt;">&nbsp;</p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; height: 55.15pt; padding-top: 0cm;border-color: #f0f0f0;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>Chlorpheniramine maleate</b></p> </td> <td style="border-bottom-color: #f0f0f0; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; height: 55.15pt; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>0.03</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; margin: 1pt 0cm; padding-top: 1pt;">&nbsp;</p> </td> <td style="border-bottom-color: #f0f0f0; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="10"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-size: 14pt;">E</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-size: 14pt;">1</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;">Sodium flavin adenine dinuleotide</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;">0.05</p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 95.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1.5pt solid; padding-top: 0cm;" rowspan="10"> <p style="text-align: center; margin: 1pt 5.65pt; padding-top: 1pt;"><span style="font-family: 標楷體; font-size: 14pt;">眼睛疲勞</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; margin: 1pt 0cm; padding-top: 1pt;">&nbsp;</p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-size: 14pt;">2</span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;">Cyanocobalamin</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;">0.02</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;" rowspan="2"> <p style="text-align: center; margin: 1pt 0cm; padding-top: 1pt;">&nbsp;</p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-size: 14pt;">3</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>Retinol acetate</b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b><span>50,000units/&nbsp; 100ml</span></b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>Retinol palmitate</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; margin: 1pt 0cm; padding-top: 1pt;">&nbsp;</p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-size: 14pt;">4</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>Pyridoxine hydrochloride</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>0.1</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; margin: 1pt 0cm; padding-top: 1pt;">&nbsp;</p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>Pyridoxal phosphate</b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>0.1</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;" rowspan="3"> <p style="text-align: center; margin: 1pt 0cm; padding-top: 1pt;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-size: 14pt;">5</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-right-color: #f0f0f0; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>Panthenol</b></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; padding-top: 0cm;border: windowtext 1pt solid;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>0.1</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-right-color: #f0f0f0; border-left-color: #f0f0f0; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>Calcium pantothenate</b></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>0.1</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-right-color: #f0f0f0; border-left-color: #f0f0f0; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>Sodium pantothenate</b></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>0.1</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; margin: 1pt 0cm; padding-top: 1pt;">&nbsp;</p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-size: 14pt;">6</span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>Tocopherol Acetate</b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>0.05</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; margin: 1pt 0cm; padding-top: 1pt;">&nbsp;</p> </td> <td style="border-bottom-color: #f0f0f0; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-right-color: #f0f0f0; border-top: windowtext 1pt solid; padding-top: 0cm;" rowspan="5"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-size: 14pt;">F</span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; padding-top: 0cm;border: windowtext 1pt solid;" rowspan="3"> <p style="text-align: center; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-size: 14pt;">1</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>L-Potassium aspartate</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>1</b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 95.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1.5pt solid; padding-top: 0cm;" rowspan="5"> <p style="text-align: center; margin: 1pt 5.65pt; padding-top: 1pt;"><span style="font-family: 標楷體; font-size: 14pt;">眼睛疲勞</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; margin: 1pt 0cm; padding-top: 1pt;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>L-Magnesium aspartate</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>1</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; margin: 1pt 0cm; padding-top: 1pt;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1pt 5.65pt;"><b>L-Potassium and magnesium aspartate (equal mixture)</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>2</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; margin: 1pt 0cm; padding-top: 1pt;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-size: 14pt;">2</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1pt 0cm 1pt 5.65pt; padding-top: 1pt;"><b>Taurine (Aminoethylsulfonic acid)</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>1</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; margin: 1pt 0cm; padding-top: 1pt;">&nbsp;</p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-size: 14pt;">3</span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>Sodium chondroitin sulfate</b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>0.5</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; margin: 1pt 0cm;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1.5pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-right-color: #f0f0f0; border-top: windowtext 1pt solid; padding-top: 0cm;" rowspan="5"> <p style="text-align: center; margin: 0cm 1.4pt 0pt;"><span style="font-size: 14pt;">G</span></p> </td> <td style="border-bottom: windowtext 1.5pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="5"> <p style="text-align: center; margin: 0cm 1.4pt 0pt;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1pt 5.65pt;"><b>Potassium chloride</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 5.65pt;"><b><span style="font-family: 標楷體;">－</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 95.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1.5pt solid; padding-top: 0cm;" rowspan="5"> <p style="text-align: center; margin: 1pt 5.65pt;"><b><span style="font-family: 標楷體; font-size: 14pt;">沖洗眼部</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; margin: 1pt 0cm;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1pt 5.65pt;"><b>Calcium chloride</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 5.65pt;"><b><span style="font-family: 標楷體;">－</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; margin: 1pt 0cm;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1pt 5.65pt;">Sodium chloride</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 5.65pt;"><b><span style="font-family: 標楷體;">－</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; margin: 1pt 0cm;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1pt 5.65pt;"><b>Sodium bicarbonate</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 5.65pt;"><b><span style="font-family: 標楷體;">－</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; margin: 1pt 0cm;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1pt 5.65pt;"><b>Sodium carbonate</b></p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 5.65pt;"><b><span style="font-family: 標楷體;">－</span></b><b> </b></p> </td> </tr> </tbody></table><p style="page-break-before: always; line-height: 20pt; margin: 0cm 0cm 6pt 72pt;"><span style="font-family: 標楷體; font-size: 14pt;">表一、有效成分種類（續）</span> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="margin: 3pt 0cm; padding-top: 1pt;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-top: windowtext 1.5pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-family: 標楷體; font-size: 14pt;">欄 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1.5pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-family: 標楷體; font-size: 14pt;">項 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1.5pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; margin: 3pt 42.55pt; padding-top: 1pt;"><span style="font-family: 標楷體; font-size: 14pt;">有效成分 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1.5pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 3pt 5.65pt;"><span style="font-family: 標楷體; font-size: 14pt;">最高含量(%)</span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 95.5pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1.5pt solid; border-right: windowtext 1.5pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; margin: 3pt 22.7pt; padding-top: 1pt;"><span style="font-family: 標楷體; font-size: 14pt;">適應症 </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; margin: 1pt 0cm;">&nbsp;</p> </td> <td style="border-bottom-color: #f0f0f0; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-right-color: #f0f0f0; padding-top: 0cm;" rowspan="5"> <p style="text-align: center; margin: 0cm 1.4pt 0pt;"><span style="font-size: 14pt;">G</span></p> </td> <td style="border-bottom-color: #f0f0f0; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="5"> <p style="text-align: center; margin: 0cm 1.4pt 0pt;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1pt 5.65pt;"><b>Sodium carbonate, dried</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 5.65pt;"><b><span style="font-family: 標楷體;">－</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 95.5pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1.5pt solid; padding-top: 0cm;" rowspan="5"> <p style="text-align: center; margin: 1pt 5.65pt;"><b><span style="font-family: 標楷體; font-size: 14pt;">沖洗眼部</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; margin: 1pt 0cm;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1pt 5.65pt;"><b>Magnesium sulfate</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 5.65pt;"><b><span style="font-family: 標楷體;">－</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; margin: 1pt 0cm;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1pt 5.65pt;"><b>Sodium phosphate, dibasic</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 5.65pt;"><b><span style="font-family: 標楷體;">－</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; margin: 1pt 0cm;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1pt 5.65pt;"><b>Sodium phosphate, monobasic</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 5.65pt;"><b><span style="font-family: 標楷體;">－</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; margin: 1pt 0cm;">&nbsp;</p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1pt 5.65pt;"><b>Potassium phosphate, monobasic</b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 5.65pt;"><b><span style="font-family: 標楷體;">－</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; margin: 1pt 0cm;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1.5pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-right-color: #f0f0f0; border-top: windowtext 1pt solid; padding-top: 0cm;" rowspan="8"> <p style="text-align: center; margin: 0cm 1.4pt 0pt;"><span style="font-size: 14pt;">H</span></p> </td> <td style="border-bottom-color: #f0f0f0; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="6"> <p style="text-align: center; margin: 0cm 1.4pt 0pt;"><span style="font-size: 14pt;">1</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1pt 5.65pt 1pt 28.9pt;"><span>(a)<span style="font: 7pt times new roman;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></span><span>Cellulose der.<br /> Carboxymethylcellose sodium<br /> Hydroxyethyl cellulose<br /> Hydroxypropyl methylcellose<br /> Methylcellulose</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 5.65pt;"><span><br /> 0.2 - 2.5<br /> 0.2 - 2.5<br /> 0.2 - 2.5<br /> 0.2 - 2.5</span></p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 95.5pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" rowspan="8"> <p style="text-justify: inter-ideograph; text-align: justify; margin: 1pt 5.65pt;"><span style="font-family: 標楷體; font-size: 14pt;">暫時緩解因眼睛乾澀所引起灼熱感與刺激感</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; margin: 1pt 0cm;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1pt 5.65pt 1pt 20.4pt;"><span>(b) </span>Dextran 70</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 5.65pt;">0.1</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; margin: 1pt 0cm;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1pt 5.65pt 1pt 20.4pt;"><span>(c) </span>Gelatin</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 5.65pt;">0.01</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; margin: 1pt 0cm;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1pt 5.65pt 1pt 29.45pt;"><span>(d)<span style="font: 7pt times new roman;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></span><span>Polyols liquid<br /> Glycerin<br /> Polyethylene glycol 300<br /> Polyethylene glycol 400<br /> Polysorbate 80<br /> Propylene glycol</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 5.65pt;"><span><br /> 0.2 &ndash; 1.0<br /> 0.2 &ndash; 1.0<br /> 0.2 &ndash; 1.0<br /> 0.2 &ndash; 1.0<br /> 0.2 &ndash; 1.0</span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 24.55pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; height: 24.55pt; padding-top: 0cm;border-color: #f0f0f0;"> <p style="margin: 1pt 0cm; padding-top: 1pt;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; height: 24.55pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1pt 5.65pt 1pt 20.4pt;"><span>(e) </span>Polyvinyl alcohol</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; height: 24.55pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 5.65pt;">0.1 &ndash; 4.0</p> </td> </tr> <tr style="page-break-inside: avoid; height: 24.6pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; height: 24.6pt; padding-top: 0cm;border-color: #f0f0f0;"> <p style="margin: 1pt 0cm; padding-top: 1pt;">&nbsp;</p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; height: 24.6pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1pt 5.65pt 1pt 18.1pt;"><span>(f)</span> Povidone </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; height: 24.6pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 5.65pt;">0.1 &ndash; 2.0</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="margin: 1pt 0cm; padding-top: 1pt;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1.5pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; margin: 2pt 1.4pt; padding-top: 1pt;"><span style="font-size: 14pt;">2</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1pt 5.65pt 1pt 28.9pt;"><span>(a)<span style="font: 7pt times new roman;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></span><span>Lanolin Preparations<br /> Anhydrous lanolin<br /> Lanolin</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 5.65pt;"><span><br /> 1 &ndash; 10<br /> 1 &ndash; 10</span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 0cm; padding-top: 1pt;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1pt 5.65pt 1pt 29.45pt;"><span>(b)<span style="font: 7pt times new roman;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></span><span>Oleaginous Ingredients<br /> Light mineral oil<br /> Mineral oil<br /> Paraffin<br /> Petrolatum<br /> White ointment<br /> White petrolatum<br /> White wax<br /> Yellow wax</span></p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 5.65pt;"><span><br /> 50<br /> 50<br /> 5<br /> 100<br /> 100<br /> 100<br /> 5<br /> 5</span></p> </td> </tr> </tbody></table><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 3pt 0cm 12pt 72pt; layout-grid-mode: char;"><b><span style="font-size: 14pt;">*</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">可使用各國藥典收載之</span></b><b><span style="font-size: 14pt;">Epinephrine Solution</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">替代之。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; page-break-before: always; line-height: 20pt; margin: 0cm 21pt 9pt 70.9pt;"><span style="font-family: 標楷體; font-size: 14pt;">(二)</span><span style="font-family: 標楷體; font-size: 14pt;">配合規則：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 21pt 6pt 89.6pt;"><span style="font-size: 14pt;">(A)</span><span style="font-family: 標楷體; font-size: 14pt;">一般眼用製劑（</span><span style="font-size: 14pt;">1</span><span style="font-family: 標楷體; font-size: 14pt;">）之配合規則：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 3pt 111.7pt;"><span style="font-size: 14pt;">1、</span><b><span style="font-family: 標楷體; font-size: 14pt;">必須配合成分及可配合成分（見表二）：</span></b> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 3pt 126.45pt;"><span style="font-size: 14pt;">(a)</span><b><span style="font-family: 標楷體; font-size: 14pt;">必須配合成分：指表一中</span></b><b><span style="font-size: 14pt;">A</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">項所含之有效成分。一般眼用製劑（</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">）之配方中，需含一種必須配合成分。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 6pt 126.45pt;"><span style="font-size: 14pt;">(b)</span><b><span style="font-family: 標楷體; font-size: 14pt;">可配合成分：指表一中</span></b><b><span style="font-size: 14pt;">C</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄</span></b><b><span style="font-size: 14pt;">6</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">項之</span></b><b><span style="font-size: 14pt;">Zinc sulfate</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">，或</span></b><b><span style="font-size: 14pt;">H</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">項所含之有效成分。</span></b> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 6pt 111.7pt;"><span style="font-size: 14pt;">2、</span><b><span style="font-family: 標楷體; font-size: 14pt;">各必須配合成分可單方使用。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 6pt 111.7pt;"><span style="font-size: 14pt;">3、</span><span style="font-family: 標楷體; font-size: 14pt;">一種必須配合成分＋</span><span style="font-size: 14pt;">Zinc sulfate</span><span style="font-family: 標楷體; font-size: 14pt;">，複方配合使用。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 21pt 6pt 111.7pt;"><span style="font-size: 14pt;">4、</span><span style="font-family: 標楷體; font-size: 14pt;">一種必須配合成分＋</span><span style="font-size: 14pt;">H</span><span style="font-family: 標楷體; font-size: 14pt;">欄</span><span style="font-size: 14pt;">1</span><span style="font-family: 標楷體; font-size: 14pt;">項之一種有效成分，複方配合使用。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 21pt 9pt 111.7pt;"><span style="font-size: 14pt;">5、</span><span style="font-family: 標楷體; font-size: 14pt;">一種必須配合成分＋</span><span style="font-size: 14pt;">Zinc sulfate</span><span style="font-family: 標楷體; font-size: 14pt;">＋</span><span style="font-size: 14pt;">H</span><span style="font-family: 標楷體; font-size: 14pt;">欄</span><span style="font-size: 14pt;">1</span><span style="font-family: 標楷體; font-size: 14pt;">項之一種有效成分，複方配合使用。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 21pt 6pt 89.6pt;"><span style="font-size: 14pt;">(B)</span><b><span style="font-family: 標楷體; font-size: 14pt;">一般眼用製劑（</span></b><b><span style="font-size: 14pt;">2</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">）之配合規則：</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 3pt 111.7pt;"><span style="font-size: 14pt;">1、</span><b><span style="font-family: 標楷體; font-size: 14pt;">必須配合成分及可配合成分（見表二）：</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 3pt 126.45pt;"><span style="font-size: 14pt;">(a)</span><b><span style="font-family: 標楷體; font-size: 14pt;">必須配合成分：指表一中</span></b><b><span style="font-size: 14pt;">A</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄</span></b><b><span style="font-size: 14pt;">2</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">項，</span></b><b><span style="font-size: 14pt;">C</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄，</span></b><b><span style="font-size: 14pt;">D</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄，</span></b><b><span style="font-size: 14pt;">E</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">項、</span></b><b><span style="font-size: 14pt;">2</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">項、</span></b><b><span style="font-size: 14pt;">3</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">項，或</span></b><b><span style="font-size: 14pt;">F</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">項所含之有效成分。一般眼用製劑（</span></b><b><span style="font-size: 14pt;">2</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">）之配方中，至少需含一種必須配合成分</span></b><span style="font-family: 標楷體; font-size: 14pt;">。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 6pt 126.45pt;"><span style="font-size: 14pt;">(b)</span><b><span style="font-family: 標楷體; font-size: 14pt;">可配合成分：指表一中</span></b><b><span style="font-size: 14pt;">B</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄，</span></b><b><span style="font-size: 14pt;">E</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄</span></b><b><span style="font-size: 14pt;">4</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">項、</span></b><b><span style="font-size: 14pt;">5</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">項、</span></b><b><span style="font-size: 14pt;">6</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">項，或</span></b><b><span style="font-size: 14pt;">F</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄</span></b><b><span style="font-size: 14pt;">2</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">項、</span></b><b><span style="font-size: 14pt;">3</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">項所含之有效成分。</span></b> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 6pt 111.7pt;"><span style="font-size: 14pt;">2、</span><b><span style="font-family: 標楷體; font-size: 14pt;">一般眼用製劑（</span></b><b><span style="font-size: 14pt;">2</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">）之配方中，除上項</span></b><b><span style="font-size: 14pt;"> (a) </span></b><b><span style="font-family: 標楷體; font-size: 14pt;">必須配合成分可相互配合使用外，亦可與上項</span></b><b><span style="font-size: 14pt;"> (b) </span></b><b><span style="font-family: 標楷體; font-size: 14pt;">可配合成分，複方配合使用。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 6pt 111.7pt;"><span style="font-size: 14pt;">3、</span><b><span style="font-family: 標楷體; font-size: 14pt;">以下各欄，僅可各配合一種有效成分使用：</span></b><b><span style="font-size: 14pt;">A</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄</span></b><b><span style="font-size: 14pt;">2</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">項，或</span></b><b><span style="font-size: 14pt;">D</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 9pt 111.7pt;"><span style="font-size: 14pt;">4、</span><b><span style="font-family: 標楷體; font-size: 14pt;">以下各欄，最多可各配合三種有效成分使用，但各欄每一項中僅可使用一種有效成分：</span></b><b><span style="font-size: 14pt;">C</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄、</span></b><b><span style="font-size: 14pt;">E</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄或</span></b><b><span style="font-size: 14pt;">F</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄。</span></b> </p><p style="text-justify: inter-ideograph; text-align: justify; page-break-before: always; line-height: 20pt; margin: 0cm 21pt 6pt 89.6pt;"><span style="font-size: 14pt;">(C)</span><span style="font-family: 標楷體; font-size: 14pt;">人工淚液：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 21pt 3pt 111.7pt;"><span style="font-size: 14pt;">1、</span><b><span style="font-family: 標楷體; font-size: 14pt;">人工淚液（</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">）必須配合成分及可配合成分（見表二）：</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 21pt 3pt 126.45pt;"><span style="font-size: 14pt;">(a)</span><b><span style="font-family: 標楷體; font-size: 14pt;">必須配合成分：指表一中</span></b><b><span style="font-size: 14pt;">F</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄</span></b><b><span style="font-size: 14pt;">2</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">項、</span></b><b><span style="font-size: 14pt;">3</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">項，或</span></b><b><span style="font-size: 14pt;">G</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄所含之有效成分。人工淚液（</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">）之配方中，至少需含一種必須配合成分。</span></b> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 6pt 126.45pt;"><span style="font-size: 14pt;">(b)</span><b><span style="font-family: 標楷體; font-size: 14pt;">可配合成分：指表一中</span></b><b><span style="font-size: 14pt;">F</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">項，或</span></b><b><span style="font-size: 14pt;">H</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">項</span></b><b><span style="font-size: 14pt;"> (a)</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">、</span></b><b><span style="font-size: 14pt;">(e)</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">、</span></b><b><span style="font-size: 14pt;">(f) </span></b><b><span style="font-family: 標楷體; font-size: 14pt;">所含之有效成分。</span></b> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 6pt 111.7pt;"><span style="font-size: 14pt;">2、</span><b><span style="font-family: 標楷體; font-size: 14pt;">人工淚液（</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">），除上項</span></b><b><span style="font-size: 14pt;"> (a) </span></b><b><span style="font-family: 標楷體; font-size: 14pt;">必須配合成分可相互配合使用外，亦可與上項</span></b><b><span style="font-size: 14pt;">(b) </span></b><b><span style="font-family: 標楷體; font-size: 14pt;">可配合成分，複方配合使用；另，亦可以僅含</span></b><b><span style="font-size: 14pt;">G</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄所含之有效成分為必須配合成分。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 6pt 111.7pt;"><span style="font-size: 14pt;">3、</span><span style="font-family: 標楷體; font-size: 14pt;">人工淚液（</span><span style="font-size: 14pt;">2</span><span style="font-family: 標楷體; font-size: 14pt;">），以</span><span style="font-size: 14pt;">H</span><span style="font-family: 標楷體; font-size: 14pt;">欄</span><span style="font-size: 14pt;">1</span><span style="font-family: 標楷體; font-size: 14pt;">項之二至三種有效成分，任意複方配合使用。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 9pt 112.8pt;"><span style="font-size: 14pt;">4、</span><span style="font-family: 標楷體; font-size: 14pt;">人工淚液（</span><span style="font-size: 14pt;">3</span><span style="font-family: 標楷體; font-size: 14pt;">），以</span><span style="font-size: 14pt;">H</span><span style="font-family: 標楷體; font-size: 14pt;">欄</span><span style="font-size: 14pt;">2</span><span style="font-family: 標楷體; font-size: 14pt;">項二種或二種以上之有效成分，任意複方配合使用。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 21pt 6pt 89.6pt;"><span style="font-size: 14pt;">(D)</span><b><span style="font-family: 標楷體; font-size: 14pt;">洗眼劑：</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 21pt 3pt 111.7pt;"><span style="font-size: 14pt;">1、</span><b><span style="font-family: 標楷體; font-size: 14pt;">必須配合成分及可配合成分（見表二）：</span></b> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 21pt 3pt 126.45pt;"><span style="font-size: 14pt;">(a)</span><b><span style="font-family: 標楷體; font-size: 14pt;">必須配合成分：指表一中</span></b><b><span style="font-size: 14pt;">C</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄，</span></b><b><span style="font-size: 14pt;">D</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄，或</span></b><b><span style="font-size: 14pt;">G</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄所含之有效成分。洗眼劑之配方中，至少需含一種必須配合成分。</span></b> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 6pt 126.45pt;"><span style="font-size: 14pt;">(b)</span><b><span style="letter-spacing: -0.2pt; font-family: 標楷體; font-size: 14pt;">可配合成分：指表一中</span></b><b><span style="letter-spacing: -0.2pt; font-size: 14pt;">E</span></b><b><span style="letter-spacing: -0.2pt; font-family: 標楷體; font-size: 14pt;">欄，或</span></b><b><span style="letter-spacing: -0.2pt; font-size: 14pt;">F</span></b><b><span style="letter-spacing: -0.2pt; font-family: 標楷體; font-size: 14pt;">欄所含之有效成分</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">。</span></b> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 6pt 111.7pt;"><span style="font-size: 14pt;">2、</span><b><span style="font-size: 14pt;">D</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄，僅可配合一種有效成分使用。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 6pt 111.7pt;"><span style="font-size: 14pt;">3、</span><b><span style="font-family: 標楷體; font-size: 14pt;">以下各欄，最多可各配合三種有效成分使用，但各欄每一項中僅可使用一種有效成分：</span></b><b><span style="font-size: 14pt;">C</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄，</span></b><b><span style="font-size: 14pt;">E</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄，或</span></b><b><span style="font-size: 14pt;">F</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 6pt 111.7pt;"><span style="font-size: 14pt;">4、</span><b><span style="font-family: 標楷體; font-size: 14pt;">以</span></b><b><span style="font-size: 14pt;">C</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄或</span></b><b><span style="font-size: 14pt;">D</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄所含之有效成分為必須配合成分之洗眼劑：除</span></b><b><span style="font-size: 14pt;">C</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄或</span></b><b><span style="font-size: 14pt;">D</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄所含之有效成分可相互配合使用外，亦可與上項</span></b><b><span style="font-size: 14pt;"> (b) </span></b><b><span style="font-family: 標楷體; font-size: 14pt;">可配合成分，複方配合使用。其適應症需標示為沖洗眼部。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 111.7pt;"><span style="font-size: 14pt;">5、</span><b><span style="font-family: 標楷體; font-size: 14pt;">以</span></b><b><span style="font-size: 14pt;">G</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄所含之有效成分為必須配合成分之洗眼劑：可含一種以上必須配合成分配合。</span></b> </p><p style="text-justify: inter-ideograph; text-align: justify; page-break-before: always; line-height: 20pt; margin: 0cm 21pt 9pt 70.9pt;"><span style="font-family: 標楷體; font-size: 14pt;">(三)</span><span style="font-family: 標楷體; font-size: 14pt;">有效成分之配合量（見表三）：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 21pt 9pt 89.6pt;"><span style="font-size: 14pt;">(A)</span><span style="font-family: 標楷體; font-size: 14pt;">各有效成分之配合量，均不得超過表一所列之最高含量。<b>洗眼劑若含</b></span><b><span style="font-size: 14pt;">C</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄，</span></b><b><span style="font-size: 14pt;">D</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄，</span></b><b><span style="font-size: 14pt;">E</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄及</span></b><b><span style="font-size: 14pt;">F</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄中之有效成分，其各有效成分之最高含量為其表一中最高含量的</span></b><b><span style="font-size: 14pt;">1/10</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">。</span></b><b><span style="font-size: 14pt;">G</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄（無機鹽類）之配合量依淚液之性狀而定，不做含量之規定。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 21pt 9pt 89.6pt;"><span style="font-size: 14pt;">(B)</span><b><span style="font-family: 標楷體; font-size: 14pt;">表一中</span></b><b><span style="font-size: 14pt;">C</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄、</span></b><b><span style="font-size: 14pt;">E</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄或</span></b><b><span style="font-size: 14pt;">F</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄，若配合同欄中二種或二種以上有效成分時，其每一有效成分的配合濃度除以最高含量所得數值的總和，不可大於</span></b><b><span style="font-size: 14pt;">2</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">。但洗眼劑的有效成分的配合濃度除以最高含量所得數值的總和，不可大於</span></b><b><span style="font-size: 14pt;">2/10</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 21pt 9pt 89.6pt;"><span style="font-size: 14pt;">(C)</span><span style="font-family: 標楷體; font-size: 14pt;">一般眼用製劑（</span><span style="font-size: 14pt;">1</span><span style="font-family: 標楷體; font-size: 14pt;">）中，</span><span style="font-size: 14pt;">A</span><span style="font-family: 標楷體; font-size: 14pt;">欄</span><span style="font-size: 14pt;">1</span><span style="font-family: 標楷體; font-size: 14pt;">項僅列單一濃度。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 21pt 9pt 89.6pt;"><span style="font-size: 14pt;">(D)</span><b><span style="font-family: 標楷體; font-size: 14pt;">一般眼用製劑（</span></b><b><span style="font-size: 14pt;">2</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">）中，若含一種必須配合成分時，則此有效成分的最低含量應為表一最高含量的</span></b><b><span style="font-size: 14pt;">1/2</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">。若含二種或二種以上必須配合成分時，則各有效成分的最低含量為表一最高含量的</span></b><b><span style="font-size: 14pt;">1/5</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 21pt 9pt 89.6pt;"><span style="font-size: 14pt;">(E)</span><b><span style="font-family: 標楷體; font-size: 14pt;">人工淚液（</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">）中，</span></b><b><span style="font-size: 14pt;">F</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄有效成分之最低含量應為表一最高含量的</span></b><b><span style="font-size: 14pt;">1/10</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">；若配合</span></b><b><span style="font-size: 14pt;">H</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">項之</span></b><b><span style="font-size: 14pt;"> (e)Polyvinyl alcohol</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">、</span></b><b><span style="font-size: 14pt;">(f)Povidone </span></b><b><span style="font-family: 標楷體; font-size: 14pt;">之有效成分，則</span></b><b><span style="font-size: 14pt;"> (e) </span></b><b><span style="font-family: 標楷體; font-size: 14pt;">及</span></b><b><span style="font-size: 14pt;"> (f) </span></b><b><span style="font-family: 標楷體; font-size: 14pt;">之最低含量，分別為</span></b><b><span style="font-size: 14pt;">0.2% </span></b><b><span style="font-family: 標楷體; font-size: 14pt;">和</span></b><b><span style="font-size: 14pt;">0.25%</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">。人工淚液之</span></b><b><span style="font-size: 14pt;">pH</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">值為</span></b><b><span style="font-size: 14pt;">5.5 - 8.0</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">，滲透壓比為</span></b><b><span style="font-size: 14pt;">0.85 - 1.55</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">（對生理食鹽水滲透壓比）。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 21pt 9pt 89.6pt;"><span style="font-size: 14pt;">(F)</span><b><span style="font-family: 標楷體; font-size: 14pt;">洗眼劑中，若配合表一</span></b><b><span style="font-size: 14pt;">C</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄或</span></b><b><span style="font-size: 14pt;">D</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄有效成分，則其最低含量為本節</span></b><b><span style="font-size: 14pt;"> (A) </span></b><b><span style="font-family: 標楷體; font-size: 14pt;">所定最高含量的</span></b><b><span style="font-size: 14pt;">1/5</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">（即表一最高含量的</span></b><b><span style="font-size: 14pt;">1/50</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">）。若配合表一</span></b><b><span style="font-size: 14pt;">E</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄或</span></b><b><span style="font-size: 14pt;">F</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄的有效成分，則其最低含量為本節</span></b><b><span style="font-size: 14pt;"> (A) </span></b><b><span style="font-family: 標楷體; font-size: 14pt;">所定最高含量的</span></b><b><span style="font-size: 14pt;">1/10</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">（即表一最高含量</span></b><b><span style="font-size: 14pt;">1/100</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">）。洗眼劑的</span></b><b><span style="font-size: 14pt;">pH</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">值為</span></b><b><span style="font-size: 14pt;">5.5 - 8.0</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">，滲透壓比為</span></b><b><span style="font-size: 14pt;">0.60 - 1.55</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">（對生理食鹽水滲透比）。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 21pt 9pt 89.6pt;"><span style="font-size: 14pt;">(G)</span><b><span style="font-family: 標楷體; font-size: 14pt;">如無其他規定，若配合表一中的</span></b><b><span style="font-size: 14pt;">E</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄</span></b><b><span style="font-size: 14pt;">4</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">項、</span></b><b><span style="font-size: 14pt;">5</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">項、</span></b><b><span style="font-size: 14pt;">6</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">項，或</span></b><b><span style="font-size: 14pt;"> F</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄</span></b><b><span style="font-size: 14pt;"> 2</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">項、</span></b><b><span style="font-size: 14pt;">3</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">項所載的有效成分時，其有效成分的最低含量為表一中最高含量的</span></b><b><span style="font-size: 14pt;">1/10</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 21pt 24pt 89.6pt;"><span style="font-size: 14pt;">(H)</span><b><span style="font-family: 標楷體; font-size: 14pt;">以</span></b><b><span style="font-size: 14pt;">G</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄（無機鹽類）所製成的製劑亦可用於人工淚液及洗眼劑，其含量以物性值規範之：</span></b><b><span style="font-size: 14pt;">pH</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">值為其中心值</span></b><b><span style="font-size: 14pt;"> &plusmn; 1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">，滲透壓比為其中心值</span></b><b><span style="font-size: 14pt;"> &plusmn; 0.2</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">。</span></b> </p><p style="text-justify: inter-ideograph; text-align: justify; page-break-before: always; line-height: 20pt; margin: 0cm 0cm 12pt 41.95pt;"><span style="font-size: 18pt;">III、</span><span style="font-family: 標楷體; font-size: 18pt;">劑型</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 24pt 41.95pt;"><span style="font-family: 標楷體; font-size: 14pt;">限於<b>點眼膏劑</b>、<b>眼用凝膠劑</b>、<b>點眼液劑</b>、<b>眼用洗劑</b>、<b>點眼懸液劑</b>。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 41.95pt;"><span style="font-size: 18pt;">IV、</span><span style="font-family: 標楷體; font-size: 18pt;">適應症</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 24pt 41.95pt;"><span style="font-family: 標楷體; font-size: 14pt;">複方眼用製劑其適應症依配合成分而異，如未配合之類別的有效成分不得記載其類別之適應症。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 41.95pt;"><span style="font-size: 18pt;">V、</span><span style="font-family: 標楷體; font-size: 18pt;">用法、用量</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 70.9pt;"><span style="font-family: 標楷體; font-size: 14pt;">(一)</span><span style="font-family: 標楷體; font-size: 14pt;">一般眼用製劑：<b>一天</b></span><b><span style="font-size: 14pt;">3</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">至</span></b><b><span style="font-size: 14pt;">6</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">次</span></b><span style="font-family: 標楷體; font-size: 14pt;">，每次</span><span style="font-size: 14pt;">1</span><span style="font-family: 標楷體; font-size: 14pt;">至</span><span style="font-size: 14pt;">2</span><span style="font-family: 標楷體; font-size: 14pt;">滴。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 70.9pt;"><span style="font-family: 標楷體; font-size: 14pt;">(二)</span><span style="font-family: 標楷體; font-size: 14pt;">人工淚液：需要時使用，<b>每次</b></span><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">至</span></b><b><span style="font-size: 14pt;">2</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">滴</span></b><span style="font-family: 標楷體; font-size: 14pt;">。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 24pt 70.9pt;"><span style="font-family: 標楷體; font-size: 14pt;">(三)</span><b><span style="font-family: 標楷體; font-size: 14pt;">洗眼劑：一天</span></b><b><span style="font-size: 14pt;">3</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">至</span></b><b><span style="font-size: 14pt;">6</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">次，必須清楚指明每次用量。會附上洗眼輔助器，如洗眼用杯，並清楚註明使用量。每次使用前，將洗眼用杯快速以水濕潤，避免污染洗眼用杯的杯緣與杯內面。將杯子裝一次使用量且拿近欲處理的眼部，壓緊以免液體流出，將頭稍向後仰，打開眼瞼且轉動眼球使洗眼液能夠充分清洗到眼部，在使用後用乾淨的水洗淨杯子。如用細管注射器，需要時灌洗眼部，利用瓶上的壓力控制溶液流出的速度</span></b><span style="font-family: 標楷體; font-size: 14pt;">。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 41.95pt;"><span style="font-size: 18pt;">VI、</span><span style="font-family: 標楷體; font-size: 18pt;">注意事項</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 70.9pt;"><span style="font-family: 標楷體; font-size: 14pt;">(一)</span><b><span style="font-family: 標楷體; font-size: 14pt;">為防止兒童誤食請妥善保管。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 70.9pt;"><span style="font-family: 標楷體; font-size: 14pt;">(二)</span><span style="font-family: 標楷體; font-size: 14pt;">避免陽光直射，宜保存於陰涼之處。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 70.9pt;"><span style="font-family: 標楷體; font-size: 14pt;">(三)</span><span style="font-family: 標楷體; font-size: 14pt;">使用前，請洗淨雙手。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 70.9pt;"><span style="font-family: 標楷體; font-size: 14pt;">(四)</span><b><span style="font-family: 標楷體; font-size: 14pt;">請依照藥品標示使用。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 70.9pt;"><span style="font-family: 標楷體; font-size: 14pt;">(五)</span><b><span style="font-family: 標楷體; font-size: 14pt;">過期眼藥水，請勿使用。瓶裝之眼藥水，開瓶</span></b><b><span style="font-size: 14pt;">30</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">天後請勿繼續使用。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 70.9pt;"><span style="font-family: 標楷體; font-size: 14pt;">(六)</span><b><span style="font-family: 標楷體; font-size: 14pt;">單劑量包裝，須一次使用完，未使用完之溶液請勿繼續使用。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; page-break-before: always; line-height: 20pt; margin: 0cm 0cm 12pt 70.9pt;"><span style="font-family: 標楷體; font-size: 14pt;">(七)</span><span style="font-family: 標楷體; font-size: 14pt;">藥液混濁、變色或出現異物時請丟棄。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 70.9pt;"><span style="font-family: 標楷體; font-size: 14pt;">(八)</span><b><span style="font-family: 標楷體; font-size: 14pt;">為避免污染藥品，</span></b><span style="font-family: 標楷體; font-size: 14pt;">使用時勿碰觸藥瓶瓶口。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 70.9pt;"><span style="font-family: 標楷體; font-size: 14pt;">(九)</span><span style="font-family: 標楷體; font-size: 14pt;">使用兩種<b>眼藥水</b>時，請隔開<b>至少</b></span><b><span style="font-size: 14pt;">5</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">分鐘後</span></b><span style="font-family: 標楷體; font-size: 14pt;">點藥。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 70.9pt;"><span style="font-family: 標楷體; font-size: 14pt;">(十)</span><span style="font-family: 標楷體; font-size: 14pt;">使用兩種眼藥時，請先使用藥水再用藥膏；<b>並請隔開至少</b></span><b><span style="font-size: 14pt;">10</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">分鐘後點藥</span></b><span style="font-family: 標楷體; font-size: 14pt;">。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 24pt 70.85pt;"><span style="font-family: 標楷體; font-size: 14pt;">(十一)</span><b><span style="font-family: 標楷體; font-size: 14pt;">使用眼藥膏時可能有視線模糊之現象產生，故建議在睡前使用較適宜。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 41.95pt;"><span style="font-size: 18pt;">VII、</span><span style="font-family: 標楷體; font-size: 18pt;">警語</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 9pt 70.9pt;"><span style="font-family: 標楷體; font-size: 14pt;">(一)</span><span style="font-family: 標楷體; font-size: 14pt;">以下情況應停藥立即就醫：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 9pt 89.6pt;"><span style="font-size: 14pt;">(A)</span><span style="font-family: 標楷體; font-size: 14pt;">連續使用三天（或</span><span style="font-size: 14pt;">72</span><span style="font-family: 標楷體; font-size: 14pt;">小時）症狀未解除。</span> </p><p style="line-height: 20pt; margin: 0cm 0cm 9pt 89.6pt;"><span style="font-size: 14pt;">(B)</span><b><span style="font-family: 標楷體; font-size: 14pt;">使用後產生</span></b><span style="font-family: 標楷體; font-size: 14pt;">眼睛劇痛、視力模糊或眼睛<b>持續</b>發紅、腫、熱、刺激感。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 9pt 89.6pt;"><span style="font-size: 14pt;">(C)</span><span style="font-family: 標楷體; font-size: 14pt;">發生過敏反應。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 89.6pt;"><span style="font-size: 14pt;">(D)</span><span style="font-family: 標楷體; font-size: 14pt;">青光眼（</span><span style="font-size: 14pt;">Glaucoma</span><span style="font-family: 標楷體; font-size: 14pt;">）患者。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 70.9pt;"><span style="font-family: 標楷體; font-size: 14pt;">(二)</span><b><span style="letter-spacing: -0.2pt; font-family: 標楷體; font-size: 14pt;">對眼用製劑之主要成分、防腐劑或其他賦形劑過敏者，不推薦使用</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 70.9pt;"><span style="font-family: 標楷體; font-size: 14pt;">(三)</span><span style="font-family: 標楷體; font-size: 14pt;">正在接受醫師治療或醫師處方眼藥之患者，<b>不應自行購買使用</b>。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 70.9pt;"><span style="font-family: 標楷體; font-size: 14pt;">(四)</span><b><span style="font-family: 標楷體; font-size: 14pt;">過度使用血管收縮劑會增加眼睛紅腫。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 70.9pt;"><span style="font-family: 標楷體; font-size: 14pt;">(五)</span><b><span style="font-family: 標楷體; font-size: 14pt;">含有汞化合物當防腐劑者：要標示所含汞的名稱及含量，及此化合物的作用為防腐劑。並註明：若對含汞化合物（或汞本身）過敏者，或使用數週後產生接觸性眼瞼炎或角結膜炎，則不要使用此類製劑。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 70.9pt;"><span style="font-family: 標楷體; font-size: 14pt;">(六)</span><b><span style="font-family: 標楷體; font-size: 14pt;">青光眼患者，除非經醫師指示，否則不要使用含血管收縮成分之製劑。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 70.9pt;"><span style="font-family: 標楷體; font-size: 14pt;">(七)</span><b><span style="font-family: 標楷體; font-size: 14pt;">含有</span></b><b><span style="font-size: 14pt;">Lysozyme HCl </span></b><b><span style="font-family: 標楷體; font-size: 14pt;">的製劑較易引起過敏，需遵從藥師、藥劑生或醫師指示使用。</span></b><b> </b></p></div><span style="font-family: times new roman,serif; font-size: 14pt;"><br style="page-break-before: always;" clear="all" /></span><p style="line-height: 20pt; margin: 0cm 0cm 6pt;"><span style="font-family: 標楷體; font-size: 14pt;">表二、配合規則</span> </p><div style="text-align: center;"><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 199pt; padding-right: 0cm; border-top: windowtext 1.5pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2" colspan="3"> <p style="text-justify: distribute-all-lines; text-align: justify; margin: 1pt 14.2pt 0pt 5cm;"><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">製劑名</span> </p> <p style="text-justify: distribute-all-lines; text-align: justify; margin: 0cm 127.6pt 1pt 14.2pt;"><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">有效成分</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 127.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1.5pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; margin: 1pt 0cm;"><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">一般眼用製劑</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 191.05pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1.5pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="3"> <p style="text-align: center; margin: 1pt 0cm;"><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">人工淚液</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 127.35pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1.5pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">洗眼劑</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 85.4pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1.5pt solid; border-right: windowtext 1.5pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-justify: distribute-all-lines; text-align: justify; margin: 1pt 1cm;"><span style="layout-grid-mode: line; font-size: 9pt;">&nbsp;</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">備註</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 0cm;"><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">（</span><span style="layout-grid-mode: line; font-size: 9pt;">1</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">）</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">（</span></b><b><span style="layout-grid-mode: line; font-size: 9pt;">2</span></b><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">）</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">（</span></b><b><span style="layout-grid-mode: line; font-size: 9pt;">1</span></b><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">）</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 0cm;"><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">（</span><span style="layout-grid-mode: line; font-size: 9pt;">2</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">）</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 0cm;"><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">（</span><span style="layout-grid-mode: line; font-size: 9pt;">3</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">）</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">（</span></b><b><span style="layout-grid-mode: line; font-size: 9pt;">1</span></b><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">）</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">（</span></b><b><span style="layout-grid-mode: line; font-size: 9pt;">2</span></b><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">）</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom-color: #f0f0f0; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 24.75pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">A</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">欄</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 24pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">1</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">項</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">Vasoconstrictors</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">（四種成分）</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">◎</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 85.4pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">僅可含一種成分</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 24pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">2</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">項</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">Vasoconstrictors</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">（八種成分）</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">◎</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 85.4pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 5.65pt;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">僅可含一種成分</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom-color: #f0f0f0; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 24.75pt; padding-right: 0cm; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">B</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">欄</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 24pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;">&nbsp;</p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">Neostigmine methyl sulfate </span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">○</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 85.4pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1.5pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 9.6pt; margin: 1pt 0cm;">&nbsp;</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom-color: #f0f0f0; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 24.75pt; padding-right: 0cm; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="8"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">C</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">欄</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 24pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">1</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">項</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">&epsilon;</span><span style="layout-grid-mode: line; font-size: 9pt;">-Aminocaproic acid </span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="5"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="8"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">◎</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="8"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="8"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="8"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="8"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">◎</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="8"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 85.4pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1.5pt solid; padding-top: 0cm;" rowspan="8"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 9.6pt; margin: 1pt 5.65pt;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">至多含三種成分，各項中僅可含一種成分</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 24pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">2</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">項</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">Allantoin&nbsp; </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 24pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">3</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">項</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">Berberines</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">（二種成分）</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 24pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">4</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">項</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">Sodium azulene sulfonate&nbsp; </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 24pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">5</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">項</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">Dipotassium glycyrrhetinate&nbsp; </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 24pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">6</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">項</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">Zinc sulfate</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">○</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">Zinc lactate</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 24pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">7</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">項</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">Lysozyme hydrochloride</span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom-color: #f0f0f0; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 24.75pt; padding-right: 0cm; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">D</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">欄</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 24pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;">&nbsp;</p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">Antihistamines</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">（二種成分）</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">◎</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">◎</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 85.4pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1.5pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 5.65pt;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">僅可含一種成分</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom-color: #f0f0f0; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 24.75pt; padding-right: 0cm; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="7"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">E</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">欄</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 24pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">1</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">項</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">Sod. Flavin adenine dinucleotide</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">◎</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="7"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="7"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="7"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="7"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">○</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="7"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 85.4pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1.5pt solid; padding-top: 0cm;" rowspan="7"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 9.6pt; margin: 1pt 5.65pt;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">至多含三種成分，各項中僅可含一種成分</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 24pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">2</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">項</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">Cyancobalamin</span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 24pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">3</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">項</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">Retinols</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">（二種成分）</span> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 10.15pt;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 24pt; padding-right: 0cm; height: 10.15pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">4</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">項</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; height: 10.15pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">Pyridoxine hydrochloride</span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; height: 10.15pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="4"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; height: 10.15pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="4"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">○</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid; height: 10.1pt;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; height: 10.1pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">Pyridoxal phosphate</span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 24pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">5</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">項</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">Pantothenates</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">（三種成分）</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 24pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">6</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">項</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">Tocopherol acetate</span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom-color: #f0f0f0; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 24.75pt; padding-right: 0cm; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">F</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">欄</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 24pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">1</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">項</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">Aspartates</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">（三種成分）</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">◎</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">○</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">○</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 85.4pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1.5pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 9.6pt; margin: 1pt 5.65pt;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">至多含三種成分，各項中僅可含一種成分</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 24pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">2</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">項</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">Taurine</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">（</span><span style="layout-grid-mode: line; font-size: 9pt;">Aminoethyl sulfonic acid</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">）</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">○</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">◎</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 24pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">3</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">項</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">Sodium chondroitin sulfate</span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom-color: #f0f0f0; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 24.75pt; padding-right: 0cm; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">G</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">欄</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 24pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;">&nbsp;</p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">Inorganic salts</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">（十種成分）</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">◎</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">◎</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 85.4pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1.5pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 9.6pt; margin: 1pt 0cm;">&nbsp;</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 24.75pt; padding-right: 0cm; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="8"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">H</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">欄</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 24pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="6"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">1</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">項</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">(a)Cellulose derivatives</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">（四種成分）</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="6"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">○</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="6"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">○</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="6"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">◎</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="6"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="6"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="6"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 85.4pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1.5pt solid; padding-top: 0cm;" rowspan="6"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">與一般眼用製劑（</span><span style="layout-grid-mode: line; font-size: 9pt;">1</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">）配合時，僅可含一種成分</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">(b)Dextran</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">(c)Gelatin</span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">(d)Polyos liquid</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">（五種成分）</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">(e)Polyvinyl alcohol</span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">○</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">(f)Povidone</span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 24pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">2</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">項</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">(a)Lanolin preparations</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">（二種成分）</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">◎</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">&times;</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 85.4pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 9.6pt; margin: 1pt 0cm;">&nbsp;</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 0cm 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">(b)<span style="letter-spacing: -0.2pt;">Oleaginous ingredients</span></span><span style="layout-grid-mode: line; letter-spacing: -0.2pt; font-family: 標楷體; font-size: 9pt;">（八種成分</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">）</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1.5pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 199pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="3"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 9.6pt; margin: 1pt 2cm;"><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">備註</span> </p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 4.25pt;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 4.25pt;"><b></b></p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 4.25pt;"><b></b></p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 9.6pt; margin: 1pt 4.25pt;"><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">可含二至三</span> <span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">種成分</span> </p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 9.6pt; margin: 1pt 4.25pt;"><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">可含二種或二種以上成分</span> </p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 4.25pt;"><b></b></p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 9.6pt; margin: 1pt 4.25pt;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">僅可含</span></b><b><span style="layout-grid-mode: line; font-size: 9pt;">G</span></b><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">欄成分</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 85.4pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 9.6pt; margin: 1pt 4.25pt;">&nbsp;</p> </td> </tr> </tbody></table></div><p style="margin: 0cm 0cm 3pt;"><span style="font-family: 標楷體; font-size: 8pt;">◎：必須配合成分</span><span style="font-size: 8pt;">&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 8pt;">○：可配合成分</span><span style="font-size: 8pt;">&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="layout-grid-mode: line; color: black; font-size: 8pt;">&times;</span><span style="font-family: 標楷體; font-size: 8pt;">：不可配合成分</span><span style="font-size: 8pt;"><br style="page-break-before: always;" clear="all" /></span><span style="font-family: 標楷體; font-size: 14pt;">表三、配合係數</span> </p><div style="text-align: center;"><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 152.05pt; padding-right: 0cm; padding-top: 0cm;border: windowtext 1pt solid;" colspan="3"> <h1 style="text-justify: distribute-all-lines; text-align: justify; line-height: 9.1pt; margin: 1.5pt 1cm;"><span style="font-family: 標楷體; font-size: 9pt; font-weight: normal;">製劑</span> </h1> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 99.95pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 5.65pt;"><span style="font-family: 標楷體; font-size: 9pt;">一般眼用製劑（</span><span style="font-size: 9pt;">1</span><span style="font-family: 標楷體; font-size: 9pt;">）</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 200pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="4"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 5.65pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">一般眼用製劑（</span></b><b><span style="font-size: 9pt;">2</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">）</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 100pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 5.65pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">人工淚液（</span></b><b><span style="font-size: 9pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">）</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 100pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 5.65pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">洗眼劑（</span></b><b><span style="font-size: 9pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">）</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 81.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="4"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 5.65pt;"><span style="font-family: 標楷體; font-size: 9pt;">備註</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 152.05pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3" colspan="3"> <h1 style="text-justify: distribute-all-lines; text-align: justify; line-height: 9.1pt; page-break-after: auto; margin: 1.5pt 1cm;"><span style="font-family: 標楷體; font-size: 9pt; font-weight: normal;">有效成分</span> </h1> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 99.95pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <h1 style="line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-family: 標楷體; font-size: 9pt; font-weight: normal;">各個成分</span> </h1> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 150pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="3"> <h1 style="line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-family: 標楷體; font-size: 9pt;">各個成分</span> </h1> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 9.1pt; margin: 1.5pt 1.4pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">同欄中含二種以上成分的配合係數</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <h1 style="line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-family: 標楷體; font-size: 9pt;">各個成分</span> </h1> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 9.1pt; margin: 1.5pt 1.4pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">同欄中含二種以上成分的配合係數</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <h1 style="line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-family: 標楷體; font-size: 9pt;">各個成分</span> </h1> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 9.1pt; margin: 1.5pt 1.4pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">同欄中含二種以上成分的配合係數</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 49.95pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-family: 標楷體; font-size: 9pt;">必須配合</span><span style="font-size: 9pt;"><br /> </span><span style="font-family: 標楷體; font-size: 9pt;">成分</span><span style="font-size: 9pt;"><br /> </span><span style="font-family: 標楷體; font-size: 9pt;">（一種）</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-family: 標楷體; font-size: 9pt;">可配合</span><span style="font-size: 9pt;"><br /> </span><span style="font-family: 標楷體; font-size: 9pt;">成分</span><span style="font-size: 9pt;"><br /> </span><span style="font-family: 標楷體; font-size: 9pt;">（一種）</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 100pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">必須配合成分</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;"><b><span style="font-family: 標楷體; font-size: 9pt;">可配合成分</span></b><b><span style="font-size: 9pt;"><br /> (</span></b><b><span style="letter-spacing: -0.3pt; font-family: 標楷體; font-size: 9pt;">成分數不拘</span></b><b><span style="font-size: 9pt;">)</span></b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">含一種</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 9.1pt; margin: 1.5pt 1.4pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">含二種以上</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 14.2pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;"><span style="font-size: 9pt;">A<br /> </span><span style="font-family: 標楷體; font-size: 9pt;">欄</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 21.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;"><span style="font-size: 9pt;">1</span><span style="font-family: 標楷體; font-size: 9pt;">項</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 116.6pt; padding-right: 0cm; border-right-color: #f0f0f0; border-left-color: #f0f0f0; padding-top: 0cm;"> <p style="line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-size: 9pt;">Vasoconstrictors</span></p> </td> <td style="border-bottom: windowtext 2.25pt solid; border-left: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 49.95pt; padding-right: 0cm; border-top: windowtext 2.25pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-family: 標楷體; font-size: 9pt;">從表一</span> </p> </td> <td style="border-bottom: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 2.25pt solid; border-right: windowtext 2.25pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;">&nbsp;</p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 100pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;">&nbsp;</span></s></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;">&nbsp;</span></s></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 100pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;">&nbsp;</span></s></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 100pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;">&nbsp;</span></s></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 81.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-family: 標楷體; font-size: 9pt;">僅可含一種</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 21.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;"><span style="font-size: 9pt;">2</span><span style="font-family: 標楷體; font-size: 9pt;">項</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 116.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-size: 9pt;">Vasoconstrictors</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 99.95pt; padding-right: 0cm; border-right-color: #f0f0f0; border-left-color: #f0f0f0; padding-top: 0cm;" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;">&nbsp;</span></s></p> </td> <td style="border-bottom: windowtext 2.25pt solid; border-left: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-top: windowtext 2.25pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-size: 9pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b><span style="font-size: 9pt;">1/2</span></b></p> </td> <td style="border-bottom: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-size: 9pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧≧</span></b><b><span style="font-size: 9pt;">1/5</span></b></p> </td> <td style="border-bottom: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 2.25pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b></b></p> </td> <td style="border-bottom: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 2.25pt solid; border-right: windowtext 2.25pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 100pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;">&nbsp;</span></s></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 100pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;">&nbsp;</span></s></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 81.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">僅可含一種</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 14.2pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;"><span style="font-size: 9pt;">B<br /> </span><span style="font-family: 標楷體; font-size: 9pt;">欄</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 21.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 116.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-size: 9pt;">Neositigmine methyl sulfate</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 99.95pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;">&nbsp;</span></s></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-size: 9pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧≧</span></b><b><span style="font-size: 9pt;">1/2</span></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-size: 9pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧≧</span></b><b><span style="font-size: 9pt;">1/5</span></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 100pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;">&nbsp;</span></s></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 100pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;">&nbsp;</span></s></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 81.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;">&nbsp;</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 14.2pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;"><span style="font-size: 9pt;">C<br /> </span><span style="font-family: 標楷體; font-size: 9pt;">欄</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 21.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;"><span style="font-size: 9pt;">1</span><span style="font-family: 標楷體; font-size: 9pt;">項</span><span style="font-size: 9pt;"><br /> </span><span style="font-family: symbol; font-size: 9pt;">&frac12;</span><span style="font-size: 9pt;"><br /> 7</span><span style="font-family: 標楷體; font-size: 9pt;">項</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 116.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-size: 9pt;">Anti-inflammatory astringents</span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 49.95pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;">&nbsp;</p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;"><span style="font-size: 9pt;">Zinc sulfate</span></p> </td> <td style="border-bottom: windowtext 2.25pt solid; border-left: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-top: windowtext 2.25pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-size: 9pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧≧</span></b><b><span style="font-size: 9pt;">1/5</span></b></p> </td> <td style="border-bottom: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 2.25pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-size: 9pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧≧</span></b><b><span style="font-size: 9pt;">1/5</span></b></p> </td> <td style="border-bottom: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 2.25pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b></b></p> </td> <td style="border-bottom: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 2.25pt solid; border-right: windowtext 2.25pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 5.65pt;"><b><span style="font-size: 9pt;">2</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 100pt; padding-right: 0cm; border-right-color: #f0f0f0; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;">&nbsp;</span></s></b></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-top: windowtext 2.25pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0.85pt;"><b><span style="font-size: 9pt;">1/10</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b><span style="font-size: 9pt;"><br /> </span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b><span style="font-size: 9pt;">1/50</span></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 2.25pt solid; border-right: windowtext 2.25pt solid; padding-top: 0cm;"> <p style="text-align: right; line-height: 9.1pt; margin: 1.5pt 8.5pt 1.5pt 2.85pt;"><b><span style="font-size: 9pt;">2/10</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 81.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">至多含</span></b><b><span style="font-size: 9pt;">3</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">種成分，各項中僅可含一種成分</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 14.2pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;"><span style="font-size: 9pt;">D<br /> </span><span style="font-family: 標楷體; font-size: 9pt;">欄</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 21.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 116.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-size: 9pt;">Antihistamines</span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 99.95pt; padding-right: 0cm; border-right-color: #f0f0f0; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;">&nbsp;</span></s></p> </td> <td style="border-bottom: windowtext 2.25pt solid; border-left: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-size: 9pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧≧</span></b><b><span style="font-size: 9pt;">1/2</span></b></p> </td> <td style="border-bottom: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-size: 9pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧≧</span></b><b><span style="font-size: 9pt;">1/5</span></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b></b></p> </td> <td style="border-bottom: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 2.25pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 100pt; padding-right: 0cm; border-right-color: #f0f0f0; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;">&nbsp;</span></s></b></p> </td> <td style="border-bottom: windowtext 2.25pt solid; border-left: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0.85pt;"><b><span style="font-size: 9pt;">1/10</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b><span style="font-size: 9pt;"><br /> </span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b><span style="font-size: 9pt;">1/50</span></b></p> </td> <td style="border-bottom: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 2.25pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;">&nbsp;</span></s></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 81.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">僅可含一種</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 14.2pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="6"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;"><span style="font-size: 9pt;">E<br /> </span><span style="font-family: 標楷體; font-size: 9pt;">欄</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 21.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;"><span style="font-size: 9pt;">1</span><span style="font-family: 標楷體; font-size: 9pt;">項</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 116.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-size: 9pt;">Sodium flavin adenine dinucleotide</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 99.95pt; padding-right: 0cm; border-right-color: #f0f0f0; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; padding-top: 0cm;" rowspan="3" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;">&nbsp;</span></s></p> </td> <td style="border-bottom: windowtext 2.25pt solid; border-left: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-size: 9pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧≧</span></b><b><span style="font-size: 9pt;">1/2</span></b></p> </td> <td style="border-bottom: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-size: 9pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧≧</span></b><b><span style="font-size: 9pt;">1/5</span></b></p> </td> <td style="border-bottom: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 2.25pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="6"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-size: 9pt;">2</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b><s style="text-line-through: double;"> </s></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 100pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="6" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;">&nbsp;</span></s></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0.85pt;"><b><span style="font-size: 9pt;">1/10</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b><span style="font-size: 9pt;"><br /> </span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b><span style="font-size: 9pt;">1/100</span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="6"> <p style="text-align: right; line-height: 9.1pt; margin: 1.5pt 8.5pt 1.5pt 2.85pt;"><b><span style="font-size: 9pt;">2/10</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 81.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="6"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">至多含</span></b><b><span style="font-size: 9pt;">3</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">種成分，各項中僅可含一種成分</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 21.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;"><span style="font-size: 9pt;">2</span><span style="font-family: 標楷體; font-size: 9pt;">項</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 116.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-size: 9pt;">Cyanocobalamin</span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 21.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;"><span style="font-size: 9pt;">3</span><span style="font-family: 標楷體; font-size: 9pt;">項</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 116.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-size: 9pt;">Retinols</span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 21.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;"><span style="font-size: 9pt;">4</span><span style="font-family: 標楷體; font-size: 9pt;">項</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 116.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-size: 9pt;">Pyridoxine hydrochloride<br /> Pyridoxal phosphate</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 99.95pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;">&nbsp;</span></s></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-size: 9pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧≧</span></b><b><span style="font-size: 9pt;">1/10</span></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0.85pt;"><b><span style="font-size: 9pt;">1/10</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b><span style="font-size: 9pt;"><br /> </span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b><span style="font-size: 9pt;">1/100</span></b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 21.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;"><span style="font-size: 9pt;">5</span><span style="font-family: 標楷體; font-size: 9pt;">項</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 116.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-size: 9pt;">Pantothenatos</span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 21.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;"><span style="font-size: 9pt;">6</span><span style="font-family: 標楷體; font-size: 9pt;">項</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 116.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-size: 9pt;">Tocopherol acetate</span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 14.2pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;"><span style="font-size: 9pt;">F<br /> </span><span style="font-family: 標楷體; font-size: 9pt;">欄</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 21.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;"><span style="font-size: 9pt;">1</span><span style="font-family: 標楷體; font-size: 9pt;">項</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 116.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-size: 9pt;">Aspartates</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 99.95pt; padding-right: 0cm; border-right-color: #f0f0f0; border-left-color: #f0f0f0; padding-top: 0cm;" rowspan="3" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;">&nbsp;</span></s></p> </td> <td style="border-bottom: windowtext 2.25pt solid; border-left: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-top: windowtext 2.25pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-size: 9pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧≧</span></b><b><span style="font-size: 9pt;">1/2</span></b></p> </td> <td style="border-bottom: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 2.25pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-size: 9pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧≧</span></b><b><span style="font-size: 9pt;">1/5</span></b></p> </td> <td style="border-bottom: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 2.25pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 2.25pt solid; border-right: windowtext 2.25pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 5.65pt;"><b><span style="font-size: 9pt;">2</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-size: 9pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧≧</span></b><b><span style="font-size: 9pt;">1/10</span></b></p> </td> <td style="border-bottom: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-right-color: #f0f0f0; border-left-color: #f0f0f0; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 5.65pt;"><b><span style="font-size: 9pt;">2</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b> </b></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; padding-top: 0cm;border: windowtext 1pt solid;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0.85pt;"><b><span style="font-size: 9pt;">1/10</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b><span style="font-size: 9pt;"><br /> </span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b><span style="font-size: 9pt;">1/100</span></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: right; line-height: 9.1pt; margin: 1.5pt 8.5pt 1.5pt 2.85pt;"><b><span style="font-size: 9pt;">2/10</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 81.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">至多含</span></b><b><span style="font-size: 9pt;">3</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">種成分，各項中僅可含一種成分</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 21.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;"><span style="font-size: 9pt;">2</span><span style="font-family: 標楷體; font-size: 9pt;">項</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 116.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-size: 9pt;">Aminoethyl sulfonic acid</span></p> </td> <td style="border-bottom-color: #f0f0f0; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-size: 9pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧≧</span></b><b><span style="font-size: 9pt;">1/10</span></b></p> </td> <td style="border-bottom: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 2.25pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-size: 9pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧≧</span></b><b><span style="font-size: 9pt;">1/10</span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0.85pt;"><b><span style="font-size: 9pt;">1/10</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b><span style="font-size: 9pt;"><br /> </span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b><span style="font-size: 9pt;">1/100</span></b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 21.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;"><span style="font-size: 9pt;">3</span><span style="font-family: 標楷體; font-size: 9pt;">項</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 116.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-size: 9pt;">Sodium chondroitin sulfate</span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 14.2pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;"><span style="font-size: 9pt;">G<br /> </span><span style="font-family: 標楷體; font-size: 9pt;">欄</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 21.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 116.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-size: 9pt;">Inorganic salts</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 99.95pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;">&nbsp;</span></s></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 200pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="4"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;">&nbsp;</span></s></b></p> </td> <td style="border-bottom: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 1.4pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">無設定含量</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 2.25pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 1.4pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">無設定含量</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 100pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;">&nbsp;</span></s></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 81.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 9.1pt; margin: 1.5pt 1.4pt;"><b><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 9pt;">以</span></b><b><span style="letter-spacing: -0.4pt; font-size: 9pt;">G</span></b><b><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 9pt;">欄所製成之人</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">工<span style="letter-spacing: -0.4pt;">淚液及洗眼劑其含</span>量<span style="letter-spacing: -0.4pt;">以物性質規範之</span></span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 14.2pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;"><span style="font-size: 9pt;">H<br /> </span><span style="font-family: 標楷體; font-size: 9pt;">欄</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 21.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;"><span style="font-size: 9pt;">1</span><span style="font-family: 標楷體; font-size: 9pt;">項</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 116.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-size: 9pt;">Hydroxyethyl cellulose, etc.</span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 49.95pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;">&nbsp;</p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-family: 標楷體; font-size: 9pt;">從表一</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 200pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2" colspan="4"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;">&nbsp;</span></s></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-size: 9pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧≧</span></b><b><span style="font-size: 9pt;">1/10</span></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: right; line-height: 9.1pt; margin: 1.5pt 0.55pt 1.5pt 1.4pt;"><b><span style="letter-spacing: -0.7pt; font-family: 標楷體; font-size: 9pt;">無設定含</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">量</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 100pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;">&nbsp;</span></s></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 81.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-family: 標楷體; font-size: 9pt;">人工淚液（</span><span style="font-size: 9pt;">2</span><span style="font-family: 標楷體; font-size: 9pt;">）之配合量從表一</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 21.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;"><span style="font-size: 9pt;">2</span><span style="font-family: 標楷體; font-size: 9pt;">項</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 116.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-size: 9pt;">Lanolin preparation<br /> Oleaginous ingredients</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 99.95pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;">&nbsp;</span></s></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;">&nbsp;</span></s></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;">&nbsp;</span></s></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 81.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-family: 標楷體; font-size: 9pt;">人工淚液（</span><span style="font-size: 9pt;">3</span><span style="font-family: 標楷體; font-size: 9pt;">）之配合量從表一</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom-color: #f0f0f0; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 152.05pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="3"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 9.1pt; margin: 1.5pt 1cm;"><span style="font-family: 標楷體; font-size: 9pt;">備註</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 99.95pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;">&nbsp;</span></s></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 200pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="4"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;">&nbsp;</span></s></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 100pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-size: 9pt;">pH</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">：</span></b><b><span style="font-size: 9pt;">5.5 - 8.0<br /> </span></b><b><span style="font-family: 標楷體; font-size: 9pt;">滲透壓比：</span></b><b><span style="font-size: 9pt;">0.85 - 1.55<br /> </span></b><b><span style="font-family: 標楷體; font-size: 9pt;">（對生理食鹽水）</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 100pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-size: 9pt;">pH</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">：</span></b><b><span style="font-size: 9pt;">5.5 - 8.0<br /> </span></b><b><span style="font-family: 標楷體; font-size: 9pt;">滲透壓比：</span></b><b><span style="font-size: 9pt;">0.60 - 1.55<br /> </span></b><b><span style="font-family: 標楷體; font-size: 9pt;">（對生理食鹽水）</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 81.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;">&nbsp;</p> </td> </tr> <tr style="page-break-inside: avoid; height: 6.7pt;"> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 14.2pt; padding-right: 0cm; height: 6.7pt; border-right-color: #f0f0f0; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;">&nbsp;</span></s></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 21.25pt; padding-right: 0cm; height: 6.7pt; border-right-color: #f0f0f0; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;">&nbsp;</span></s></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 116.6pt; padding-right: 0cm; height: 6.7pt; border-right-color: #f0f0f0; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;">&nbsp;</span></s></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 49.95pt; padding-right: 0cm; height: 6.7pt; border-right-color: #f0f0f0; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 5.65pt;">&nbsp;</p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; height: 6.7pt; border-right-color: #f0f0f0; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;">&nbsp;</span></s></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; height: 6.7pt; border-right-color: #f0f0f0; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;">&nbsp;</span></s></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; height: 6.7pt; border-right-color: #f0f0f0; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;">&nbsp;</span></s></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; height: 6.7pt; border-right-color: #f0f0f0; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;">&nbsp;</span></s></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 49.95pt; padding-right: 0cm; height: 6.7pt; border-right-color: #f0f0f0; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;">&nbsp;</span></s></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; height: 6.7pt; border-right-color: #f0f0f0; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;">&nbsp;</span></s></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; height: 6.7pt; border-right-color: #f0f0f0; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;">&nbsp;</span></s></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; height: 6.7pt; border-right-color: #f0f0f0; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;">&nbsp;</span></s></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; height: 6.7pt; border-right-color: #f0f0f0; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;">&nbsp;</span></s></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 81.6pt; padding-right: 0cm; height: 6.7pt; border-right-color: #f0f0f0; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;">&nbsp;</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 14.2pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;">&nbsp;</p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 21.25pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;">&nbsp;</p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 116.55pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: right; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-size: 9pt;">Note 1</span><span style="font-family: 標楷體; font-size: 9pt;">）</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 5.65pt;">&nbsp;</p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 100pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;" colspan="2"> <p style="line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-family: 標楷體; font-size: 9pt;">：該製劑中不可配合</span> </p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; padding-top: 0cm;border: windowtext 1pt solid;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;">&nbsp;</p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 150pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;" colspan="3"> <p style="line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-family: 標楷體; font-size: 9pt;">：沒有配合規則</span> </p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: right; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-size: 9pt;">Note 2</span><span style="font-family: 標楷體; font-size: 9pt;">）</span> </p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; padding-top: 0cm;border: windowtext 2.25pt solid;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;">&nbsp;</p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 131.6pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;" colspan="2"> <p style="line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-family: 標楷體; font-size: 9pt;">：線框為必須配合成分</span> </p> </td> </tr> </tbody></table></div><p style="line-height: 0.7pt;"><s style="text-line-through: double;"><span style="font-size: 8pt; text-decoration: none;">&nbsp;</span></s></p> 2013-12-04 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=2719&type=0;;https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=2728&type=0;;https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=5762&type=0
1420512 查驗登記類,指示藥品審查基準,解熱鎮痛劑 行政解釋 指示藥品審查基準-解熱鎮痛劑 <div style="layout-grid: 18pt none;" class="WordSection1"><p style="text-align: center; margin: 0cm 0cm 36pt;"><span style="font-family: 標楷體; font-size: 28pt;">解熱鎮痛劑</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 18pt;"><span style="font-family: 標楷體; font-size: 20pt;">壹、適用範圍</span> </p><p style="line-height: 20pt; margin: 0cm 0cm 18pt 36pt;"><b><span style="font-family: 標楷體; font-size: 14pt;">凡內服或肛門栓劑投予，以解熱鎮痛為目的之製劑，均適用本基準。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt;"><span>&nbsp;</span><span style="font-family: 標楷體; font-size: 20pt;">貳、有效成分</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 78.25pt;"><b><span style="font-family: 標楷體; font-size: 16pt;">一、</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">有效成分之種類及含量：</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 111.15pt;"><b><span style="font-family: 標楷體; font-size: 16pt;">(一)</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">本基準可配合之有效成分，記載於表一。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 111.15pt;"><b><span style="font-family: 標楷體; font-size: 16pt;">(二)</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">表一規定</span></b><b><span style="font-size: 14pt;">A</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄及</span></b><b><span style="font-size: 14pt;">B</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄中，各有效成分之</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">次最大配合量及一日最大配合量。其中，</span></b><b><span style="font-size: 14pt;">A</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄可二組擇一使用。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 111.15pt;"><b><span style="font-family: 標楷體; font-size: 16pt;">(三)</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">表一規定</span></b><b><span style="font-size: 14pt;">C</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄中各有效成分一日配合量之上下限，及</span></b><b><span style="font-size: 14pt;">D</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄各有效成分之一日最大配合量。</span></b><b> </b></p><p style="line-height: 20pt; margin: 0cm 0cm 6pt 36pt;"><span style="font-family: 標楷體; font-size: 14pt;">表一、有效成分之種類</span> </p><table style="margin: auto auto auto 37.4pt; border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0" width="600"> <tbody> <tr style="page-break-inside: avoid; height: 25.15pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 18.7pt; padding-right: 1.4pt; height: 25.15pt; padding-top: 0cm;border: windowtext 1pt solid;" rowspan="2"> <p style="text-align: center;"><span style="font-family: 標楷體;">欄</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 18.7pt; padding-right: 1.4pt; height: 25.15pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center;"><span style="font-family: 標楷體;">項</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 205.6pt; padding-right: 1.4pt; height: 25.15pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2" colspan="2"> <p style="text-align: center;"><span style="font-family: 標楷體;">有</span> <span style="font-family: 標楷體;">效</span> <span style="font-family: 標楷體;">成</span> <span style="font-family: 標楷體;">分</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 103.5pt; padding-right: 1.4pt; height: 25.15pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center;">1<span style="font-family: 標楷體;">次最大配合量</span> </p> <p style="text-align: center;"><b><span style="font-size: 11pt;">(</span></b><b><span style="font-family: 標楷體; font-size: 11pt;">最大單位含量</span></b><b><span style="font-size: 11pt;">)</span></b><b> </b><b><sup><span style="font-size: 11pt;">*1</span></sup></b> (mg)</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 103.5pt; padding-right: 1.4pt; height: 25.15pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center;"><span style="font-family: 標楷體;">一日最大配合量</span> (mg)</p> </td> </tr> <tr style="page-break-inside: avoid; height: 25.1pt;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 51.75pt; padding-right: 1.4pt; height: 25.1pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 13pt; margin: 2pt 0cm;"><b><span style="font-family: 標楷體; font-size: 11pt;">第一組</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 51.75pt; padding-right: 1.4pt; height: 25.1pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 13pt; margin: 2pt 0cm;"><b><span style="font-family: 標楷體; font-size: 11pt;">第二組</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 51.75pt; padding-right: 1.4pt; height: 25.1pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 13pt; margin: 2pt 0cm;"><b><span style="font-family: 標楷體; font-size: 11pt;">第一組</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 51.75pt; padding-right: 1.4pt; height: 25.1pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 13pt; margin: 2pt 0cm;"><b><span style="font-family: 標楷體; font-size: 11pt;">第二組</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18.7pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="4"> <p style="text-align: center;">A</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18.7pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;">1</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 205.6pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 13pt; margin: 2pt 0cm;"><span style="font-size: 11pt;">Acetaminophen</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 51.75pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 13pt; margin: 2pt 0cm;"><span style="font-size: 11pt;">325</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 51.75pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 13pt; margin: 2pt 0cm;"><b><span style="font-size: 11pt;">1000</span></b></p> <p style="text-align: center; line-height: 13pt; margin: 2pt 0cm;"><b><span style="font-size: 11pt;">(500)<sup> *1</sup></span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 51.75pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 13pt; margin: 2pt 0cm;"><span style="font-size: 11pt;">1600</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 51.75pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 13pt; margin: 2pt 0cm;"><b><span style="font-size: 11pt;">4000</span></b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18.7pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;">2</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 205.6pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 13pt; margin: 2pt 0cm;"><span style="font-size: 11pt;">Aspirin</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 51.75pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 13pt; margin: 2pt 0cm;"><b><span style="font-size: 11pt;">500</span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 51.75pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 13pt; margin: 2pt 0cm;"><b><span style="font-size: 11pt;">1000</span></b></p> <p style="text-align: center; line-height: 13pt; margin: 2pt 0cm;"><b><span style="font-size: 11pt;">(500)<sup> *1</sup></span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 51.75pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 13pt; margin: 2pt 0cm;"><span style="font-size: 11pt;">1600</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 51.75pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 13pt; margin: 2pt 0cm;"><b><span style="font-size: 11pt;">4000</span></b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18.7pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center;">3</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 205.6pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="line-height: 13pt; margin: 2pt 0cm;"><b><span style="font-size: 11pt;">Ethenzamide</span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 51.75pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; line-height: 13pt; margin: 2pt 0cm;"><b><span style="font-size: 11pt;">500</span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 51.75pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; line-height: 13pt; margin: 2pt 0cm;"><b><span style="font-size: 11pt;">&mdash;</span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 51.75pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; line-height: 13pt; margin: 2pt 0cm;"><b><span style="font-size: 11pt;">1500</span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 51.75pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; line-height: 13pt; margin: 2pt 0cm;"><b><span style="font-size: 11pt;">&mdash;</span></b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 205.6pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="line-height: 13pt; margin: 2pt 0cm;"><span style="font-size: 11pt;">Salicylamide</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 51.75pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; line-height: 13pt; margin: 2pt 0cm;"><span style="font-size: 11pt;">325</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 51.75pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; line-height: 13pt; margin: 2pt 0cm;"><b><span style="font-size: 11pt;">&mdash;</span></b> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 51.75pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; line-height: 13pt; margin: 2pt 0cm;"><span style="font-size: 11pt;">1600</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 51.75pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; line-height: 13pt; margin: 2pt 0cm;"><b><span style="font-size: 11pt;">&mdash;</span></b> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18.7pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center;">B</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18.7pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" rowspan="2"> <p style="text-align: center;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 205.6pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="line-height: 13pt; margin: 2pt 0cm;"><span style="font-size: 11pt;">Caffeine</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 103.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="text-align: center; line-height: 13pt; margin: 2pt 0cm;"><span style="font-size: 11pt;">120</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 103.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="text-align: center; line-height: 13pt; margin: 2pt 0cm;"><span style="font-size: 11pt;">300</span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 205.6pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="line-height: 13pt; margin: 2pt 0cm;"><b><span style="font-size: 11pt;">Caffeine Anhydrous</span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 103.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="text-align: center; line-height: 13pt; margin: 2pt 0cm;"><b><span style="font-size: 11pt;">120</span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 103.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="text-align: center; line-height: 13pt; margin: 2pt 0cm;"><b><span style="font-size: 11pt;">300</span></b></p> </td> </tr> <tr style="height: 66.8pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 450pt; padding-right: 1.4pt; height: 66.8pt; padding-top: 0cm;border-color: #f0f0f0;" colspan="8"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 2pt 0cm 6pt;">&nbsp;</p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 450pt; padding-right: 1.4pt; border-right-color: #f0f0f0; border-left-color: #f0f0f0; padding-top: 0cm;" colspan="8"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 2pt 0cm 6pt;"><span style="font-family: 標楷體; font-size: 14pt;">表一、有效成分之種類（續）</span> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18.7pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 3pt 1.4pt; padding-top: 1pt;"><span style="font-family: 標楷體;">欄</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18.7pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 3pt 1.4pt; padding-top: 1pt;"><span style="font-family: 標楷體;">項</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 205.6pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: distribute-all-lines; text-align: justify; margin: 3pt 2cm;"><span style="font-family: 標楷體;">有</span> <span style="font-family: 標楷體;">效</span> <span style="font-family: 標楷體;">成</span> <span style="font-family: 標楷體;">分</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 207pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="4"> <p style="text-align: center; margin: 3pt 5.65pt; padding-top: 1pt;"><span style="font-family: 標楷體;">一日配合量</span>(mg)</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18.7pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="6"> <p style="text-align: center;"><b>C</b></p> <p style="text-align: center;"><b></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18.7pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center;"><b>1</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 205.6pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="margin: 1.5pt 0cm;"><b><span style="font-size: 11pt;">Vitamin B<sub>1</sub></span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 207pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="4"> <p style="text-align: center; margin: 1.5pt 0cm;"><b><span style="font-size: 11pt;">1.8-30</span></b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 1.4pt 0.5pt 0cm; layout-grid-mode: char;"><b><span style="font-family: 標楷體;">有效成分</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 187.6pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 0cm 1.4pt 0.5pt 7.55pt; layout-grid-mode: char;"><b><span style="font-size: 11pt;">Bisbentiamine</span></b></p> <p style="margin: 0cm 1.4pt 0.5pt 7.55pt; layout-grid-mode: char;"><b><span style="font-size: 11pt;">Bisibutiamine</span></b></p> <p style="margin: 0cm 1.4pt 0.5pt 7.55pt; layout-grid-mode: char;"><b><span style="font-size: 11pt;">Cetotiamine hydrochloride</span></b></p> <p style="margin: 0cm 1.4pt 0.5pt 7.55pt; layout-grid-mode: char;"><b><span style="font-size: 11pt;">Cycotiamine</span></b></p> <p style="margin: 0cm 1.4pt 0.5pt 7.55pt; layout-grid-mode: char;"><b><span style="font-size: 11pt;">Dibenzoyl thiamine</span></b></p> <p style="margin: 0cm 1.4pt 0.5pt 7.55pt; layout-grid-mode: char;"><b><span style="letter-spacing: -0.6pt; font-size: 11pt;">Dibenzoyl thiamine hydrochloride</span></b></p> <p style="margin: 0cm 1.4pt 0.5pt 7.55pt; layout-grid-mode: char;"><b><span style="font-size: 11pt;">Fursultiamine hydrochloride</span></b></p> <p style="margin: 0cm 1.4pt 0.5pt 7.55pt; layout-grid-mode: char;"><b><span style="font-size: 11pt;">Octotiamine</span></b></p> <p style="margin: 0cm 1.4pt 0.5pt 7.55pt; layout-grid-mode: char;"><b><span style="font-size: 11pt;">Prosultiamine</span></b></p> <p style="margin: 0cm 1.4pt 0.5pt 7.55pt; layout-grid-mode: char;"><b><span style="font-size: 11pt;">Thiamine hydrochloride<br /> (Vitamin B<sub>1</sub>)</span></b></p> <p style="margin: 0cm 1.4pt 0.5pt 7.55pt; layout-grid-mode: char;"><b><span style="font-size: 11pt;">Thiamine mononitrate</span></b></p> <p style="margin: 0cm 1.4pt 0.5pt 7.55pt; layout-grid-mode: char;"><b><span style="font-size: 11pt;">Thiamine dicetylsulfate</span></b></p> <p><b><span style="font-size: 11pt;">Thiamine disulfide</span></b> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 207pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="4"> <p style="text-align: center;">&nbsp;</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18.7pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center;"><b>2</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 205.6pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="margin: 1.5pt 0cm;"><b><span style="font-size: 11pt;">Vitamin B<sub>2</sub></span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 207pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="4"> <p style="text-align: center; margin: 1.5pt 0cm;"><b><span style="font-size: 11pt;">2.25-10</span></b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 1.4pt 0.5pt 0cm; layout-grid-mode: char;"><b><span style="font-family: 標楷體;">有效成分</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 187.6pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; margin: 1.5pt 1.4pt 1.5pt 7.6pt; layout-grid-mode: char;"><b><span style="font-size: 11pt;">Riboflavin (Vitamin B<sub>2</sub>)</span></b></p> <p style="text-justify: inter-ideograph; text-align: justify; margin: 1.5pt 1.4pt 1.5pt 7.6pt; layout-grid-mode: char;"><b><span style="font-size: 11pt;">Riboflavin butyrate</span></b></p> <p style="margin: 1.5pt 0cm 1.5pt 7.6pt;"><b><span style="font-size: 11pt;">Riboflavin sodium phosphate</span></b> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 207pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="4"> <p style="text-align: center; margin: 1.5pt 0cm;">&nbsp;</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18.7pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center;"><b>3</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 205.6pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="margin: 1.5pt 0cm;"><b><span style="font-size: 11pt;">Vitamin C</span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 207pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="4"> <p style="text-align: center; margin: 1.5pt 0cm;"><b><span style="font-size: 11pt;">82.5-500</span></b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1.5pt 0cm;"><b><span style="font-family: 標楷體;">有效成分</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 187.6pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; margin: 1.5pt 1.4pt 1.5pt 7.6pt; layout-grid-mode: char;"><b><span style="font-size: 11pt;">Ascorbic acid (Vitamin C)</span></b></p> <p style="text-justify: inter-ideograph; text-align: justify; margin: 1.5pt 1.4pt 1.5pt 7.6pt; layout-grid-mode: char;"><b><span style="font-size: 11pt;">L-Ascorbyl palmitate</span></b></p> <p style="text-justify: inter-ideograph; text-align: justify; margin: 1.5pt 1.4pt 1.5pt 7.6pt; layout-grid-mode: char;"><b><span style="font-size: 11pt;">L-Ascorbyl stearate</span></b></p> <p style="text-justify: inter-ideograph; text-align: justify; margin: 1.5pt 1.4pt 1.5pt 7.6pt; layout-grid-mode: char;"><b><span style="font-size: 11pt;">Calcium ascorbate</span></b></p> <p style="margin: 1.5pt 0cm 1.5pt 7.6pt;"><b><span style="font-size: 11pt;">Sodium ascorbate</span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 207pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="4"> <p style="text-align: center; margin: 1.5pt 0cm;"><b></b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18.7pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center;"><span style="font-family: 標楷體;">欄</span><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18.7pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center;"><span style="font-family: 標楷體;">項</span><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 205.6pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2" colspan="2"> <p style="text-align: center;"><span style="font-family: 標楷體;">有效成分</span><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 207pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="4"> <p style="text-align: center; margin: 3pt 0cm;"><span style="font-family: 標楷體;">一日最大配合量</span><span>(g)<b><sup>*2</sup></b></span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 103.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; margin: 1pt 1.4pt;"><span style="font-family: 標楷體;">浸</span> <span style="font-family: 標楷體;">膏</span><sup><span><br /> </span></sup><span style="letter-spacing: -0.7pt; font-size: 9pt;">(</span><span style="letter-spacing: -0.7pt; font-family: 標楷體; font-size: 9pt;">原生藥換算量</span><span style="letter-spacing: -0.7pt; font-size: 9pt;">)</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 103.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; margin: 1pt 1.4pt;"><span style="font-family: 標楷體;">粉</span> <span style="font-family: 標楷體;">末</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18.7pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="4"> <p style="text-align: center;"><b>D</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18.7pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" rowspan="4"> <p style="text-align: center;"><b></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 205.6pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="margin: 1.5pt 5.65pt; layout-grid-mode: char;"><b><span style="font-size: 11pt;">Glycyrrhizae radix </span></b><b><span style="font-family: 標楷體; font-size: 11pt;">甘草</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 103.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; margin: 1.5pt 0cm; layout-grid-mode: char;"><b><span style="font-size: 11pt;">5</span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 103.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; margin: 1.5pt 0cm; layout-grid-mode: char;"><b><span style="font-size: 11pt;">1.5</span></b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 205.6pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="margin: 1.5pt 5.65pt; layout-grid-mode: char;"><b><span style="font-size: 11pt;">Cinnamomi cortex </span></b><b><span style="font-family: 標楷體; font-size: 11pt;">桂皮</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 103.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; margin: 1.5pt 0cm; layout-grid-mode: char;"><b><span style="font-size: 11pt;">5</span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 103.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; margin: 1.5pt 0cm; layout-grid-mode: char;"><b><span style="font-size: 11pt;">1</span></b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 205.6pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="margin: 1.5pt 5.65pt; layout-grid-mode: char;"><b><span style="font-size: 11pt;">Zingiberis rhizoma </span></b><b><span style="font-family: 標楷體; font-size: 11pt;">生薑</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 103.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; margin: 1.5pt 0cm; layout-grid-mode: char;"><b><span style="font-size: 11pt;">3</span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 103.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; margin: 1.5pt 0cm; layout-grid-mode: char;"><b><span style="font-size: 11pt;">1</span></b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 205.6pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="margin: 1.5pt 5.65pt; layout-grid-mode: char;"><b><span style="font-size: 11pt;">Paeoniae radix </span></b><b><span style="font-family: 標楷體; font-size: 11pt;">芍藥</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 103.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; margin: 1.5pt 0cm; layout-grid-mode: char;"><b><span style="font-size: 11pt;">5</span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 103.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; margin: 1.5pt 0cm; layout-grid-mode: char;"><b><span style="font-size: 11pt;">2</span></b></p> </td> </tr> </tbody></table><p style="line-height: 20pt; margin: 3pt 0cm 3pt 63pt;"><span style="font-size: 14pt;">*1. </span><b><span style="font-family: 標楷體; font-size: 14pt;">最大單位含量：為限制錠劑、膠囊、栓劑、散劑</span></b><b><span style="font-size: 14pt;">&hellip;&hellip;</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">等之每製劑單位（例如：每錠、每顆、每包</span></b><b><span style="font-size: 14pt;">&hellip;&hellip;</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">）中有效成分之最高含量。</span></b> </p><p style="line-height: 20pt; margin: 3pt 0cm 18pt 62.85pt;"><span style="font-size: 14pt;">*2. </span><b><span style="font-family: 標楷體; font-size: 14pt;">同一成分之浸膏與粉末不可同時使用。浸膏之一日最大配合量係以原生藥經抽提製成浸膏所用的原生藥量表示之。</span></b><b> </b></p><p style="line-height: 20pt; margin: 0cm 0cm 12pt;"><span style="font-family: 標楷體; font-size: 14pt;">二、配合規則（見表二）：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 72.05pt; layout-grid-mode: char;"><b><span style="font-family: 標楷體; font-size: 14pt;">（一）必須配合成分：</span></b><b> </b></p><ol> <li>第一組製劑之必須配合成分：指表一A欄中之各有效成分。配方中至少需含一種，最多可同時配合三種必須配合成分。 <ol> <li>第二組製劑之必須配合成分：指表一A欄1項及2項中之有效成分。配方中至少需含一種，最多可同時配合二種必須配合成分。</li> </ol> </li></ol><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 72.05pt; layout-grid-mode: char;"><b><span style="font-family: 標楷體; font-size: 14pt;">（二）可配合成分：</span></b><b> </b></p><ol> <li>指表一B欄、C欄及D欄中之有效成分，可與A欄必須配合成分複方配合使用。若第二組製劑配合D欄成分時，須檢附十大先進國中一國以上採用之處方依據。</li> <li>B欄中至多可配合一種成分。</li></ol><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 18pt 72.05pt; layout-grid-mode: char;"><b><span style="font-family: 標楷體; font-size: 14pt;">（三）製劑中含生藥成分者（表一</span></b><b><span style="font-size: 14pt;">D</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄），應做生藥成分之定性試驗；對於藥典等公定書所收載之生藥有指標成分定量者，應做定量試驗。</span></b> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt; layout-grid-mode: char;"><b><span style="font-family: 標楷體; font-size: 14pt;">三、有效成分之配合量（見表二）</span></b><span style="font-family: 標楷體; font-size: 14pt;">：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 9pt 63pt;"><b><span style="font-family: 標楷體; font-size: 16pt;">(一)</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">表一</span></b><b><span style="font-size: 14pt;">A</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄成分：</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 9pt 90pt; layout-grid-mode: char;"><span style="font-size: 16pt;">1、</span><b><span style="font-family: 標楷體; font-size: 14pt;">各有效成分之</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">次最大配合量及一日最大配合量，依表一該製劑配合組別之規定。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 9pt 90pt; layout-grid-mode: char;"><span style="font-size: 16pt;">2、</span><b><span style="font-family: 標楷體; font-size: 14pt;">各有效成分之每次最高配合劑量及每日最高劑量不得超過表一所列之</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">次最大配合量及一日最大配合量。</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">第二組</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">製劑中含</span></b><b><span style="font-size: 14pt;">Acetaminophen</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">或</span></b><b><span style="font-size: 14pt;">Aspirin</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">時，每製劑單位最高含量不得超過表一最大單位含量之規定。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 48pt 89.9pt; layout-grid-mode: char;"><span style="font-size: 16pt;">3、</span><b><span style="font-family: 標楷體; font-size: 14pt;">同欄中配合一種有效成分時，</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">該配合成分之配合係數應介於</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">及</span></b><b><span style="font-size: 14pt;">1/2</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">之間</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 9pt 90pt; layout-grid-mode: char;"><span style="font-size: 16pt;">4、</span><b><span style="font-family: 標楷體; font-size: 14pt;">第一組製劑：同欄中配合二種或三種有效成分時，</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">該欄之配合係數應介於</span></b><b><span style="font-size: 14pt;">38/30</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">及</span></b><b><span style="font-size: 14pt;">1/2</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">之間，且該欄各配合成分每日劑量之配合係數下限不得小於</span></b><b><span style="font-size: 14pt;">1/5</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 18pt 89.9pt; layout-grid-mode: char;"><span style="font-size: 16pt;">5、</span><b><span style="font-family: 標楷體; font-size: 14pt;">第二組製劑：同欄中配合二種有效成分時，</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">該欄之配合係數應介於</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">及</span></b><b><span style="font-size: 14pt;">1/2</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">之間，且該欄各配合成分每日劑量之配合係數下限不得小於</span></b><b><span style="font-size: 14pt;">1/5</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 6pt 153pt;"><span style="font-size: 16pt;">6、</span><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p style="text-align: center;"><b><sub><span style="font-size: 14pt;">i = 1</span></sub></b></p> </div> </td> </tr> </tbody></table><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p style="text-align: center;"><b><sub><span style="font-size: 14pt;">n</span></sub></b></p> </div> </td> </tr> </tbody></table><b><span style="font-family: 標楷體; font-size: 14pt;">配合係數＝</span></b><b><span style="font-size: 14pt;">&Sigma;</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">（</span></b><b><span style="font-size: 14pt;">X<sub>i</sub> / mX<sub>i</sub></span></b><b><span style="font-family: 標楷體; font-size: 14pt;">）</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 6pt 153pt;"><b><span style="letter-spacing: -1.3pt; font-family: 標楷體; font-size: 14pt;">＝</span></b><b><span style="letter-spacing: -1.6pt; font-family: 標楷體; font-size: 14pt;">（</span></b><b><span style="letter-spacing: -1.6pt; font-size: 14pt;">X<sub>1</sub> / mX<sub>1</sub></span></b><b><span style="letter-spacing: -1.6pt; font-family: 標楷體; font-size: 14pt;">）</span></b><b><span style="letter-spacing: -1.6pt; font-size: 14pt;">+</span></b><b><span style="letter-spacing: -1.6pt; font-family: 標楷體; font-size: 14pt;">（</span></b><b><span style="letter-spacing: -1.6pt; font-size: 14pt;">X<sub>2</sub> / mX<sub>2</sub></span></b><b><span style="letter-spacing: -1.6pt; font-family: 標楷體; font-size: 14pt;">）</span></b><b><span style="letter-spacing: -1.6pt; font-size: 14pt;">+&hellip;&hellip;+</span></b><b><span style="letter-spacing: -1.6pt; font-family: 標楷體; font-size: 14pt;">（</span></b><b><span style="letter-spacing: -1.6pt; font-size: 14pt;">X<sub>n</sub> / mX<sub>n</sub></span></b><b><span style="letter-spacing: -1.3pt; font-family: 標楷體; font-size: 14pt;">）</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 3pt 90pt;"><b><span style="font-size: 14pt;">X<sub>i</sub></span></b><b><span style="font-family: 標楷體; font-size: 14pt;">：各欄配合成分</span></b><b><span style="font-size: 14pt;">i</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">之每日劑量</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 3pt 90pt;"><b><span style="font-size: 14pt;">mX<sub>i</sub></span></b><b><span style="font-family: 標楷體; font-size: 14pt;">：各欄配合成分</span></b><b><span style="font-size: 14pt;">i</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">之一日最大配合量（第一、二組製劑應分別採用其規定之一日最大配合量）</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 89.85pt;"><b><span style="font-size: 14pt;">n</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">：各欄之配合成分數</span></b> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 9pt 62.95pt; layout-grid-mode: char;"><b><span style="font-family: 標楷體; font-size: 16pt;">(二)</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">配方中含表一</span></b><b><span style="font-size: 14pt;">B</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄成分：</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 9pt 90pt; layout-grid-mode: char;"><span style="font-size: 16pt;">1、</span><b><span style="font-family: 標楷體; font-size: 14pt;">各有效成分之每次最高配合劑量及每日最高劑量不得超過表一所列之</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">次最大配合量及一日最大配合量。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 9pt 90pt; layout-grid-mode: char;"><span style="font-size: 16pt;">2、</span><b><span style="font-family: 標楷體; font-size: 14pt;">配方中含</span></b><b><span style="font-size: 14pt;">B</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄有效成分時，該欄之配合係數應介於</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">及</span></b><b><span style="font-size: 14pt;">1/5</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">之間。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 9pt 105.95pt;"><span style="font-size: 16pt;">3、</span><b><span style="font-family: 標楷體; font-size: 14pt;">配合係數＝</span></b><b><span style="font-size: 14pt;">X / mX</span></b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 89.85pt;"><b><span style="font-size: 14pt;">X</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">：</span></b><b><span style="font-size: 14pt;">B</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄中，配合成分</span></b><b><span style="font-size: 14pt;">x</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">之每日劑量</span></b><b><span style="font-size: 14pt;"><br />mX</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">：</span></b><b><span style="font-size: 14pt;">B</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄中，配合成分</span></b><b><span style="font-size: 14pt;">x</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">之一日最大配合量</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 9pt 63pt; layout-grid-mode: char;"><b><span style="font-family: 標楷體; font-size: 16pt;">(三)</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">配方中含表一</span></b><b><span style="font-size: 14pt;">C</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄成分：</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 9pt 90pt; layout-grid-mode: char;"><span style="font-size: 16pt;">1、</span><b><span style="font-size: 14pt;">C</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄各配合成分一日配合量之上下限依表一之規定。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 72pt 89.9pt; layout-grid-mode: char;"><span style="font-size: 16pt;">2、</span><b><span style="font-size: 14pt;">C</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">項、</span></b><b><span style="font-size: 14pt;">2</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">項及</span></b><b><span style="font-size: 14pt;">3</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">項中配合二種或二種以上成分時，該項之配合係數不可大於</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">。即該項各配合成分之每日劑量除以該成分之一日最大配合量，所得數值的總和不可大於</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 6pt 153pt;"><span style="font-size: 16pt;">3、</span><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p style="text-align: center;"><b><sub><span style="font-size: 14pt;">i = 1</span></sub></b></p> </div> </td> </tr> </tbody></table><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p style="text-align: center;"><b><sub><span style="font-size: 14pt;">n</span></sub></b></p> </div> </td> </tr> </tbody></table><b><span style="font-family: 標楷體; font-size: 14pt;">配合係數＝</span></b><b><span style="font-size: 14pt;">&Sigma;</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">（</span></b><b><span style="font-size: 14pt;">X<sub>i</sub> / mX<sub>i</sub></span></b><b><span style="font-family: 標楷體; font-size: 14pt;">）</span></b><b><span style="font-size: 14pt;"><br /></span></b><b><span style="letter-spacing: -1.3pt; font-family: 標楷體; font-size: 14pt;">＝</span></b><b><span style="letter-spacing: -1.6pt; font-family: 標楷體; font-size: 14pt;">（</span></b><b><span style="letter-spacing: -1.6pt; font-size: 14pt;">X<sub>1</sub> / mX<sub>1</sub></span></b><b><span style="letter-spacing: -1.6pt; font-family: 標楷體; font-size: 14pt;">）</span></b><b><span style="letter-spacing: -1.6pt; font-size: 14pt;">+</span></b><b><span style="letter-spacing: -1.6pt; font-family: 標楷體; font-size: 14pt;">（</span></b><b><span style="letter-spacing: -1.6pt; font-size: 14pt;">X<sub>2</sub> / mX<sub>2</sub></span></b><b><span style="letter-spacing: -1.6pt; font-family: 標楷體; font-size: 14pt;">）</span></b><b><span style="letter-spacing: -1.6pt; font-size: 14pt;">+&hellip;&hellip;+</span></b><b><span style="letter-spacing: -1.6pt; font-family: 標楷體; font-size: 14pt;">（</span></b><b><span style="letter-spacing: -1.6pt; font-size: 14pt;">X<sub>n</sub> / mX<sub>n</sub></span></b><b><span style="letter-spacing: -1.3pt; font-family: 標楷體; font-size: 14pt;">）</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 3pt 135pt;"><b><span style="font-size: 14pt;">X<sub>i</sub></span></b><b><span style="font-family: 標楷體; font-size: 14pt;">：</span></b><b><span style="font-size: 14pt;">C</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄配合成分</span></b><b><span style="font-size: 14pt;">i</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">之每日劑量</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 3pt 135pt;"><b><span style="font-size: 14pt;">mX<sub>i</sub></span></b><b><span style="font-family: 標楷體; font-size: 14pt;">：</span></b><b><span style="font-size: 14pt;">C</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄配合成分</span></b><b><span style="font-size: 14pt;">i</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">之一日最大配合量</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 108pt; layout-grid-mode: char;"><b><span style="font-size: 14pt;">n</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">：</span></b><b><span style="font-size: 14pt;">C</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄之配合成分數</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 9pt 63pt; layout-grid-mode: char;"><b><span style="font-family: 標楷體; font-size: 16pt;">(四)</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">配方中含表一</span></b><b><span style="font-size: 14pt;">D</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄成分：</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 9pt 90pt; layout-grid-mode: char;"><span style="font-size: 16pt;">1、</span><b><span style="font-family: 標楷體; font-size: 14pt;">同欄中配合一種成分時，</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">該欄之配合係數應介於</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">及</span></b><b><span style="font-size: 14pt;">1/10</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">之間</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 9pt 90pt; layout-grid-mode: char;"><span style="font-size: 16pt;">2、</span> <span style="z-index: 251659264; position: absolute; left: 0pt;"><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div style="padding-bottom: 0pt; padding-left: 0pt; padding-right: 0pt; padding-top: 0pt;" class="shape"> <p style="text-align: center;"><b><sub><span style="font-size: 14pt;">n</span></sub></b></p> </div> </td> </tr> </tbody></table></span><b><span style="font-family: 標楷體; font-size: 14pt;">同欄中配合二種或二種以上成分時，該配合成分之配合係數不可大於</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">，</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">且該欄各配合成分每日劑量之配合係數下限不得小於</span></b><b><span style="font-size: 14pt;">1/10</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 6pt 153pt;"><span style="font-size: 16pt;">3、</span> <span style="z-index: 251658240; position: absolute; left: 0pt;"><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div style="padding-bottom: 0pt; padding-left: 0pt; padding-right: 0pt; padding-top: 0pt;" class="shape"> <p style="text-align: center;"><b><sub><span style="font-size: 14pt;">i = 1</span></sub></b></p> </div> </td> </tr> </tbody></table></span><b><span style="font-family: 標楷體; font-size: 14pt;">配合係數＝</span></b><b><span style="font-size: 14pt;">&Sigma;</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">（</span></b><b><span style="font-size: 14pt;">X<sub>i</sub> / mX<sub>i</sub></span></b><b><span style="font-family: 標楷體; font-size: 14pt;">）</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 6pt 153pt;"><b><span style="letter-spacing: -1.3pt; font-family: 標楷體; font-size: 14pt;">＝</span></b><b><span style="letter-spacing: -1.6pt; font-family: 標楷體; font-size: 14pt;">（</span></b><b><span style="letter-spacing: -1.6pt; font-size: 14pt;">X<sub>1</sub> / mX<sub>1</sub></span></b><b><span style="letter-spacing: -1.6pt; font-family: 標楷體; font-size: 14pt;">）</span></b><b><span style="letter-spacing: -1.6pt; font-size: 14pt;">+</span></b><b><span style="letter-spacing: -1.6pt; font-family: 標楷體; font-size: 14pt;">（</span></b><b><span style="letter-spacing: -1.6pt; font-size: 14pt;">X<sub>2</sub> / mX<sub>2</sub></span></b><b><span style="letter-spacing: -1.6pt; font-family: 標楷體; font-size: 14pt;">）</span></b><b><span style="letter-spacing: -1.6pt; font-size: 14pt;">+&hellip;&hellip;+</span></b><b><span style="letter-spacing: -1.6pt; font-family: 標楷體; font-size: 14pt;">（</span></b><b><span style="letter-spacing: -1.6pt; font-size: 14pt;">X<sub>n</sub> / mX<sub>n</sub></span></b><b><span style="letter-spacing: -1.3pt; font-family: 標楷體; font-size: 14pt;">）</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 3pt 135pt;"><b><span style="font-size: 14pt;">X<sub>i</sub></span></b><b><span style="font-family: 標楷體; font-size: 14pt;">：</span></b><b><span style="font-size: 14pt;">D</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄配合成分</span></b><b><span style="font-size: 14pt;">i</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">之每日劑量</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 3pt 135pt;"><b><span style="font-size: 14pt;">mX<sub>i</sub></span></b><b><span style="font-family: 標楷體; font-size: 14pt;">：</span></b><b><span style="font-size: 14pt;">D</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄配合成分</span></b><b><span style="font-size: 14pt;">i</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">之一日最大配合量</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 30pt 108pt; layout-grid-mode: char;"><b><span style="font-size: 14pt;">n</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">：</span></b><b><span style="font-size: 14pt;">D</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄之配合成分數</span></b><b> </b></p><p style="line-height: 20pt; margin: 0cm 0cm 18pt;"><span style="font-family: 標楷體; font-size: 20pt;">參、劑型</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 5.65pt 18pt 59.3pt;"><span style="font-family: 標楷體; font-size: 14pt;">一、限於錠劑、<b>膜衣錠、糖衣錠</b>、膠囊劑、<b>軟膠囊劑、內服</b>液劑、<b>懸液劑</b>、糖漿劑、散劑、<b>溶液用粉劑、糖漿用粉劑、內服</b>顆粒劑、<b>糖漿用</b>顆粒劑、<b>細粒劑</b>。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 5.65pt 18pt 59.1pt;"><b><span style="font-family: 標楷體; font-size: 14pt;">二、內服液劑（含糖漿劑）成人</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">次用量須</span></b><b><span style="font-size: 14pt;">5mL</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">以上，零售最大單位包裝不得超過三日用量。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 5.65pt 18pt 36pt;"><b><span style="font-family: 標楷體; font-size: 14pt;">三、含</span></b><b><span style="font-size: 14pt;">Salicylates</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">水楊酸類產品可為腸溶劑型。</span></b><b> </b></p><p style="line-height: 20pt; margin: 0cm 0cm 78pt 67.5pt;"><span style="font-family: 標楷體; font-size: 14pt;">四、<b>含</b></span><b><span style="font-size: 14pt;">A</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">項、</span></b><b><span style="font-size: 14pt;">2</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">項或</span></b><b><span style="font-size: 14pt;">3</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">項</span></b><b><span style="font-size: 14pt;">Salicylamide</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">之單方製劑得有栓劑</span></b><span style="font-family: 標楷體; font-size: 14pt;">。</span> </p><p style="line-height: 20pt; margin: 0cm 0cm 18pt;"><span style="font-family: 標楷體; font-size: 20pt;">肆、適應症</span> </p><p style="line-height: 20pt; margin: 0cm 0cm 30pt 36pt;"><b><span style="font-family: 標楷體; font-size: 14pt;">退燒、止痛（緩解頭痛、牙痛、咽喉痛、關節痛、神經痛、肌肉酸痛、月經痛）。</span></b><b> </b></p><h1 style="line-height: 20pt; margin: 0cm 0cm 18pt;"><span style="font-family: 標楷體; font-size: 20pt;">伍、用法用量</span> </h1><p style="line-height: 20pt; margin: 0cm 0cm 18pt 59.2pt;"><span style="font-family: 標楷體; font-size: 14pt;">一、<b>第一組製劑：發燒</b>或需要時服用，若症狀持續，則每</span><span style="font-size: 14pt;">4~6</span><span style="font-family: 標楷體; font-size: 14pt;">小時可重複服用<b>。每</b></span><b><span style="font-size: 14pt;">24</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">小時內不可超過</span></b><b>○</b><b><span style="font-family: 標楷體; font-size: 14pt;">次。</span></b><b><s> </s></b></p><p style="line-height: 20pt; margin: 0cm 0cm 18pt 59.2pt;"><b><span style="font-family: 標楷體; font-size: 14pt;">二、第二組製劑：發燒或需要時服用，若症狀持續，則每</span></b><b><span style="font-size: 14pt;">4~6</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">小時可重複服用，每次</span></b><b>○</b><b><span style="font-size: 14pt;">~</span></b><b>○</b><b><span style="font-family: 標楷體; font-size: 14pt;">錠（或顆、包</span></b><b><span style="font-size: 14pt;">&hellip;&hellip;</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">），初次應使用最小建議劑量，再視症狀增減用量。每</span></b><b><span style="font-size: 14pt;">24</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">小時內不可超過</span></b><b>○</b><b><span style="font-family: 標楷體; font-size: 14pt;">次。</span></b><b> </b></p><p style="line-height: 20pt; margin: 0cm 0cm 18pt 59.2pt;"><b><span style="font-family: 標楷體; font-size: 14pt;">三、含</span></b><b><span style="font-size: 14pt;">Salicylates</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">水楊酸類產品，須記載「飯後半小時內服用為宜」</span></b><span style="font-family: 標楷體; font-size: 14pt;">。</span> </p><p style="line-height: 20pt; margin: 0cm 0cm 18pt 36pt;"><b><span style="font-family: 標楷體; font-size: 14pt;">四、腸溶製劑應整粒吞服，不得剝半或嚼碎。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 18pt 45.1pt;"><b><span style="font-family: 標楷體; font-size: 14pt;">五、栓劑不得剝半使用</span></b><b><span style="font-family: 標楷體; font-size: 11pt;">。</span></b><b> </b></p><p style="line-height: 20pt; margin: 0cm 0cm 6pt 36pt;"><span style="font-family: 標楷體; font-size: 14pt;">六、年齡分配係數：</span> </p><p style="line-height: 20pt; margin: 0cm 5.65pt 30pt 72pt;"><span style="font-size: 14pt;">12</span><span style="font-family: 標楷體; font-size: 14pt;">歲以上，適用成人劑量。</span><span style="font-size: 14pt;"><br />6</span><span style="font-family: 標楷體; font-size: 14pt;">歲以上未滿</span><span style="font-size: 14pt;">12</span><span style="font-family: 標楷體; font-size: 14pt;">歲，適用成人劑量之</span><span style="font-size: 14pt;">1/2</span><span style="font-family: 標楷體; font-size: 14pt;">。</span><span style="font-size: 14pt;"><br />3</span><span style="font-family: 標楷體; font-size: 14pt;">歲以上未滿</span> <span style="font-size: 14pt;">6</span><span style="font-family: 標楷體; font-size: 14pt;">歲，適用成人劑量之</span><span style="font-size: 14pt;">1/4</span><span style="font-family: 標楷體; font-size: 14pt;">。</span><span style="font-size: 14pt;"><br />3</span><span style="font-family: 標楷體; font-size: 14pt;">歲以下之嬰幼兒，<b>請洽醫師診治，不宜自行使用</b>。</span> </p><p style="line-height: 20pt; margin: 0cm 0cm 18pt;"><span style="font-family: 標楷體; font-size: 20pt;">陸、注意事項</span> </p><p style="line-height: 20pt; margin: 0cm 0cm 18pt 63pt;"><span style="font-size: 16pt;">一、<span style="font: 7pt times new roman;">&nbsp; </span></span><b><span style="font-family: 標楷體; font-size: 14pt;">為防止兒童誤食請妥善保管</span></b><span style="font-family: 標楷體; font-size: 14pt;">。</span> </p><p style="line-height: 20pt; margin: 0cm 0cm 18pt 63pt;"><span style="font-size: 16pt;">二、<span style="font: 7pt times new roman;">&nbsp; </span></span><span style="font-family: 標楷體; font-size: 14pt;">避免陽光直射，宜保存於陰涼之處。</span> </p><p style="line-height: 20pt; margin: 0cm 0cm 18pt 62.95pt;"><span style="font-size: 16pt;">三、<span style="font: 7pt times new roman;">&nbsp; </span></span><span style="font-family: 標楷體; font-size: 14pt;">除非<b>有醫師藥師藥劑生</b>指示，孕婦及授乳婦不建議自行使用。</span> </p><p style="line-height: 20pt; margin: 0cm 0cm 18pt 63pt;"><b><span style="font-size: 16pt;">四、 </span></b><span style="font-family: 標楷體; font-size: 14pt;">勿超過建議劑量，<b>若有不適情況產生，</b>應<b>停止使用並請教醫師藥師藥劑生</b>。</span><b> </b></p><p style="line-height: 20pt; margin: 0cm 0cm 18pt 62.95pt;"><span style="font-size: 16pt;">五、<span style="font: 7pt times new roman;">&nbsp; </span></span><span style="font-family: 標楷體; font-size: 14pt;">懸液劑使用前須振搖均勻，並使用廠商所附量器量取藥量。</span> </p><p style="line-height: 20pt; margin: 0cm 0cm 18pt 63pt;"><b><span style="font-size: 16pt;">六、 </span></b><b><span style="font-family: 標楷體; font-size: 14pt;">栓劑限使用於肛門，若藥劑過軟時，請置於低溫待較硬後再使用。</span></b><b> </b></p><p style="line-height: 20pt; margin: 0cm 0cm 30pt 62.95pt;"><b><span style="font-size: 16pt;">七、 </span></b><b><span style="font-family: 標楷體; font-size: 14pt;">不得併服含酒精飲料。</span></b><b> </b></p><p style="line-height: 20pt; margin: 0cm 0cm 16pt;"><span style="font-family: 標楷體; font-size: 20pt;">柒、警語</span> </p><p style="line-height: 20pt; margin: 0cm 0cm 16pt 62.95pt;"><span style="font-size: 14pt;">一、<span style="font: 7pt times new roman;">&nbsp;&nbsp;&nbsp; </span></span><span style="font-family: 標楷體; font-size: 14pt;">服用後，若有發疹、發紅、噁心、嘔吐、食慾不振、頭暈、耳鳴等症狀時，應停藥並就醫。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 24pt;"><span style="font-size: 14pt;">二、<span style="font: 7pt times new roman;">&nbsp;&nbsp;&nbsp; </span></span><span style="font-family: 標楷體; font-size: 14pt;">除非<b>有醫師藥師藥劑生</b>指示，請遵循下列情況服用：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 81pt;"><span style="font-size: 14pt;">(一)<span style="font: 7pt times new roman;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></span><span style="font-size: 14pt;">3</span><span style="font-family: 標楷體; font-size: 14pt;">歲以下不建議自行使用。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 18pt 81pt;"><span style="font-size: 14pt;">(二)<span style="font: 7pt times new roman;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></span><span style="font-family: 標楷體; font-size: 14pt;">曾經因藥物引起過敏症狀者不得使用。</span> </p><p style="line-height: 20pt; margin: 0cm 0cm 16pt 62.95pt;"><b><span style="font-size: 14pt;">三、<span style="font: 7pt times new roman;">&nbsp;&nbsp; </span></span></b><b><span style="font-family: 標楷體; font-size: 14pt;">服用本類製劑三天後，發燒、疼痛症狀未見改善，應停藥就醫。</span></b><b> </b></p><p style="line-height: 20pt; margin: 0cm 0cm 16pt 62.95pt;"><b><span style="font-size: 14pt;">四、<span style="font: 7pt times new roman;">&nbsp;&nbsp; </span></span></b><b><span style="font-family: 標楷體; font-size: 14pt;">成人不得連續服用本類製劑超過</span></b><b><span style="font-size: 14pt;">7</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">天，小孩不得超過</span></b><b><span style="font-size: 14pt;">3</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">天，視情形需要，繼續服用本類製劑前，請洽醫師。</span></b><b> </b></p><p style="line-height: 20pt; margin: 0cm 0cm 10pt 62.95pt;"><b><span style="font-size: 14pt;">五、<span style="font: 7pt times new roman;">&nbsp;&nbsp; </span></span></b><b><span style="font-family: 標楷體; font-size: 14pt;">含</span></b><b><span style="font-size: 14pt;">Acetaminophen</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">（表一</span></b><b><span style="font-size: 14pt;">A</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">項）之本類製劑，增列下述警語：</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 16pt 62.95pt;"><b><span style="font-family: 標楷體; font-size: 14pt;">酒精警語：若每日喝三杯或更多之酒精性飲料，請詢問醫師是否能服用本藥，因為</span></b><b><span style="font-size: 14pt;">Acetaminophen</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">可能造成肝損害。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 62.95pt;"><b><span style="font-size: 14pt;">六、<span style="font: 7pt times new roman;">&nbsp;&nbsp; </span></span></b><b><span style="font-family: 標楷體; font-size: 14pt;">含</span></b><b><span style="font-size: 14pt;">Acetaminophen</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">（表一</span></b><b><span style="font-size: 14pt;">A</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">項）配合其他解熱鎮痛成分（表一</span></b><b><span style="font-size: 14pt;">A</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄</span></b><b><span style="font-size: 14pt;">2</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">項及</span></b><b><span style="font-size: 14pt;">3</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">項）之本類製劑，增列下述警語：</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 48pt 62.95pt;"><b><span style="font-family: 標楷體; font-size: 14pt;">酒精警語：若每日喝三杯或更多之酒精性飲料，請詢問醫師是否能服用本藥，因為【產品成分】可能造成肝損害及胃出血。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 63pt;"><b><span style="font-size: 14pt;">七、<span style="font: 7pt times new roman;">&nbsp;&nbsp; </span></span></b><b><span style="font-family: 標楷體; font-size: 14pt;">含水楊酸類（表一</span></b><b><span style="font-size: 14pt;">A</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄</span></b><b><span style="font-size: 14pt;">2</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">項及</span></b><b><span style="font-size: 14pt;">3</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">項）之本類製劑，增列下述警語：</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 62.95pt;"><b><span style="font-family: 標楷體; font-size: 14pt;">本藥含【成分名稱】，應注意下列事項：</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 18pt 89.9pt;"><b><span style="font-size: 14pt;">(一)<span style="font: 7pt times new roman;">&nbsp; </span></span></b><b><span style="font-family: 標楷體; font-size: 14pt;">酒精警語：若每日喝三杯或更多之酒精性飲料，請詢問醫師是否能服用本藥，因為【產品成分】可能造成胃出血。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 90pt;"><b><span style="font-size: 14pt;">(二)<span style="font: 7pt times new roman;">&nbsp; </span></span></b><span style="letter-spacing: -0.3pt; font-family: 標楷體; font-size: 14pt;">除非<b>有醫師藥師藥劑生</b>指示，</span><span style="font-family: 標楷體; font-size: 14pt;">請遵循下列情況服用<b><span style="letter-spacing: -0.1pt;">：</span></b></span><b> </b></p><ol> <li><span style="font-family: 標楷體; font-size: 14pt;">本藥不得使用於</span><b><span style="font-size: 14pt;">12</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">歲以下</span></b><span style="font-family: 標楷體; font-size: 14pt;">兒童<b>，亦不得使用於成人</b>之水痘或流行性感冒症狀之解除。因其可能與一種罕見而嚴重之疾病</span><span style="font-size: 14pt;">─</span><span style="font-family: 標楷體; font-size: 14pt;">雷氏症候群（</span><span style="font-size: 14pt;">Reye's Syndrome</span><span style="font-family: 標楷體; font-size: 14pt;">）有相關性。</span> </li> <li><span style="font-family: 標楷體; font-size: 14pt;">曾有消化性潰瘍或使用抗凝血劑之患者，不得服用本藥。</span> </li></ol><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 18pt 90pt;"><span style="font-size: 14pt;">(三)<span style="font: 7pt times new roman;">&nbsp; </span></span><b><span style="font-family: 標楷體; font-size: 14pt;">蠶豆症（</span></b><b><span style="font-size: 14pt;">6-</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">磷酸葡萄糖脫氫酶缺乏症，</span></b><b><span style="font-size: 14pt;">Glucose-6-Phosphate Dehydrogenase Deficiency</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">）患者，不得服用本藥。</span></b> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 18pt 90pt;"><span style="font-size: 14pt;">(四)<span style="font: 7pt times new roman;">&nbsp; </span></span><span style="font-family: 標楷體; font-size: 14pt;">可能引起胃腸不適、胃腸出血、皮膚出疹、出血傾向、<b>氣喘</b>、耳鳴等不適症狀。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 18pt 63pt;"><b><span style="font-size: 14pt;">八、<span style="font: 7pt times new roman;">&nbsp;&nbsp; </span></span></b><b><span style="font-family: 標楷體; font-size: 14pt;">含咖啡因成分（表一</span></b><b><span style="font-size: 14pt;">B</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄）之本類製劑加入下述警語：</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 18pt 62.95pt;"><b><span style="font-family: 標楷體; font-size: 14pt;">本藥含咖啡因類成分，應限制再服用含咖啡因藥品、飲料（如：茶、咖啡、可樂等），過多的咖啡因會引起神經緊張，興奮與失眠，且常會引起心搏過速。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 66.4pt;"><b><span style="font-family: 標楷體; font-size: 14pt;">九、含甘草（表一</span></b><b><span style="font-size: 14pt;">D</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄）一日配合量超過</span></b><b><span style="font-size: 14pt;">1 g</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">（或浸膏之原生藥換算量為</span></b><b><span style="font-size: 14pt;">1 g</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">以上）之本類製劑，加入下述警語：</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 63pt;"><b><span style="font-family: 標楷體; font-size: 14pt;">本藥含【成分名稱】，應注意下列事項：</span></b><b> </b></p><p style="line-height: 20pt; margin: 0cm 0cm 12pt 94.5pt;"><b><span style="font-size: 14pt;">(</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">一</span></b><b><span style="font-size: 14pt;">)</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">除非有醫師藥師藥劑生指示，高齡者與有嚴重腹痛、噁心、嘔吐、水腫症狀及高血壓、心臟功能障礙、腎臟功能障礙之病患請勿服用本藥。</span></b><b> </b></p><p style="line-height: 20pt; margin: 0cm 0cm 18pt 94.4pt;"><b><span style="font-size: 14pt;">(</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">二</span></b><b><span style="font-size: 14pt;">)</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">服用中發現有尿量減少、面部或手足浮腫、眼皮沉重、手部僵硬，血壓升高、頭痛等現象，應立即停藥就醫。</span></b><b> </b></p><p style="line-height: 20pt; margin: 0cm 0cm 12pt 26.95pt;"><b><span style="font-family: 標楷體; font-size: 14pt;">十、栓劑之本類製劑加入下述警語：</span></b><b> </b></p><p style="line-height: 20pt; margin: 0cm 0cm 18pt 94.4pt;"><b><span style="font-family: 標楷體; font-size: 14pt;">會造成直腸刺激感、腹部不適，腹瀉者不宜使用。</span></b><b> </b></p></div><b><span style="font-family: times new roman,serif; font-size: 14pt;"><br style="page-break-before: always;" clear="all" /></span></b><p><b><span style="font-family: 標楷體;">表二、配合規則、配合係數</span></b><b> </b></p><table style="margin: auto auto auto 0.75pt; border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0" width="972"> <tbody> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1.5pt double; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 99pt; padding-right: 0cm; border-right-color: #f0f0f0; border-top: windowtext 1.5pt solid; padding-top: 0cm;" rowspan="3" colspan="3"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 11.4pt; margin: 1pt 17pt; layout-grid-mode: char;"><span style="font-family: 標楷體; font-size: 9pt;">有效成分</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1.5pt double; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 189pt; padding-right: 0cm; border-top: windowtext 1.5pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="4"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 11.4pt; margin: 1pt 42.55pt; layout-grid-mode: char;"><span style="font-family: 標楷體; font-size: 9pt;">第一組製劑</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 171pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1.5pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="4"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 11.4pt; margin: 1pt 42.55pt; layout-grid-mode: char;"><span style="font-family: 標楷體; font-size: 9pt;">第二組製劑</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 270pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1.5pt solid; border-right: windowtext 1.5pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 11.4pt; margin: 1pt 3cm; layout-grid-mode: char;"><span style="font-family: 標楷體; font-size: 9pt;">備註</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom-color: #f0f0f0; border-left: windowtext 1.5pt double; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 27pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt; layout-grid-mode: char;"><span style="font-family: 標楷體; font-size: 9pt;">配合規則</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 54pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 11.4pt; margin: 1pt 1.4pt;"><span style="letter-spacing: -0.1pt; font-family: 標楷體; font-size: 9pt;">同類成</span><span style="font-family: 標楷體; font-size: 9pt;">分</span><span style="font-size: 9pt;"><br /> </span><span style="letter-spacing: -0.1pt; font-family: 標楷體; font-size: 9pt;">配合一</span><span style="font-family: 標楷體; font-size: 9pt;">種</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 108pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 0cm; layout-grid-mode: char;"><span style="font-family: 標楷體; font-size: 9pt;">同類成分</span><span style="font-size: 9pt;"><br /> </span><span style="font-family: 標楷體; font-size: 9pt;">至少配合二種</span> </p> </td> <td style="border-bottom: windowtext 1.5pt double; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 27pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt; layout-grid-mode: char;"><span style="font-family: 標楷體; font-size: 9pt;">配合規則</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 54pt; padding-right: 0cm; border-right-color: #f0f0f0; border-left-color: #f0f0f0; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 11.4pt; margin: 1pt 1.4pt;"><span style="letter-spacing: -0.1pt; font-family: 標楷體; font-size: 9pt;">同類成</span><span style="font-family: 標楷體; font-size: 9pt;">分</span><span style="font-size: 9pt;"><br /> </span><span style="letter-spacing: -0.1pt; font-family: 標楷體; font-size: 9pt;">配合一</span><span style="font-family: 標楷體; font-size: 9pt;">種</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 0cm; layout-grid-mode: char;"><span style="font-family: 標楷體; font-size: 9pt;">同類成分</span><span style="font-size: 9pt;"><br /> </span><span style="font-family: 標楷體; font-size: 9pt;">至少配合二種</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1.5pt double; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 54pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 11.4pt; margin: 1pt 1.4pt;"><span style="letter-spacing: -0.1pt; font-family: 標楷體; font-size: 9pt;">配合係</span><span style="font-family: 標楷體; font-size: 9pt;">數</span> </p> </td> <td style="border-bottom: windowtext 1.5pt double; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 11.4pt; margin: 1pt 1.4pt;"><span style="letter-spacing: -0.1pt; font-family: 標楷體; font-size: 9pt;">配合係</span><span style="font-family: 標楷體; font-size: 9pt;">數</span> </p> </td> <td style="border-bottom: windowtext 1.5pt double; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 11.4pt; margin: 1pt 0.55pt;"><span style="letter-spacing: -1.4pt; font-family: 標楷體; font-size: 9pt;">各成分一</span><span style="font-family: 標楷體; font-size: 9pt;">日</span><span style="font-size: 9pt;"><br /> </span><span style="letter-spacing: -1.4pt; font-family: 標楷體; font-size: 9pt;">配合量下</span><span style="font-family: 標楷體; font-size: 9pt;">限</span> </p> </td> <td style="border-bottom: windowtext 1.5pt double; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 54pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 11.4pt; margin: 1pt 1.4pt;"><span style="letter-spacing: -0.1pt; font-family: 標楷體; font-size: 9pt;">配合係</span><span style="font-family: 標楷體; font-size: 9pt;">數</span> </p> </td> <td style="border-bottom: windowtext 1.5pt double; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 11.4pt; margin: 1pt 1.4pt;"><span style="letter-spacing: -0.1pt; font-family: 標楷體; font-size: 9pt;">配合係</span><span style="font-family: 標楷體; font-size: 9pt;">數</span> </p> </td> <td style="border-bottom: windowtext 1.5pt double; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 11.4pt; margin: 1pt 0.55pt;"><span style="letter-spacing: -1.4pt; font-family: 標楷體; font-size: 9pt;">各成分一</span><span style="font-family: 標楷體; font-size: 9pt;">日</span><span style="font-size: 9pt;"><br /> </span><span style="letter-spacing: -1.4pt; font-family: 標楷體; font-size: 9pt;">配合量下</span><span style="font-family: 標楷體; font-size: 9pt;">限</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 18pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt; layout-grid-mode: char;"><span style="font-size: 9pt;">A<br /> </span><span style="font-family: 標楷體; font-size: 9pt;">欄</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 81pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1.5pt double; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 11.4pt; margin: 1pt 5.65pt; layout-grid-mode: char;"><span style="font-size: 9pt;">1</span><span style="font-family: 標楷體; font-size: 9pt;">項</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 27pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1.5pt double; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt; layout-grid-mode: char;"><span style="font-family: 標楷體; font-size: 9pt;">◎</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 54pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 11.4pt; margin: 1pt 1.4pt;"><span style="letter-spacing: -2pt; font-size: 9pt;">1</span><span style="letter-spacing: -2pt; font-family: 標楷體; font-size: 9pt;">≧</span> <span style="letter-spacing: -0.2pt; font-family: 標楷體; font-size: 9pt;">≧</span><span style="letter-spacing: -0.2pt; font-size: 9pt;">1/2</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt;"><b><span style="letter-spacing: -0.2pt; font-size: 9pt;">38/30</span></b><span style="letter-spacing: -2pt; font-family: 標楷體; font-size: 9pt;">≧</span> <span style="letter-spacing: -0.2pt; font-family: 標楷體; font-size: 9pt;">≧</span><span style="letter-spacing: -0.2pt; font-size: 9pt;">1/2</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt;"><b><span style="font-size: 9pt;">1/5</span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 27pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt; layout-grid-mode: char;"><span style="font-family: 標楷體; font-size: 9pt;">◎</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 54pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 11.4pt; margin: 1pt 1.4pt;"><span style="letter-spacing: -0.2pt; font-size: 9pt;">1</span><span style="letter-spacing: -2pt; font-family: 標楷體; font-size: 9pt;">≧</span> <span style="letter-spacing: -0.2pt; font-family: 標楷體; font-size: 9pt;">≧</span><span style="letter-spacing: -0.2pt; font-size: 9pt;">1/2</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;" rowspan="2"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 11.4pt; margin: 1pt 1.4pt;"><span style="letter-spacing: -0.2pt; font-size: 9pt;">1</span><span style="letter-spacing: -2pt; font-family: 標楷體; font-size: 9pt;">≧</span> <span style="letter-spacing: -0.2pt; font-family: 標楷體; font-size: 9pt;">≧</span><span style="letter-spacing: -0.2pt; font-size: 9pt;">1/2</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt;"><b><span style="font-size: 9pt;">1/5</span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 270pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1.5pt double; border-right: windowtext 1.5pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 11.4pt; margin: 1pt 2.85pt 0.5pt 11.9pt; layout-grid-mode: char;"><span style="font-family: wingdings; font-size: 11pt;">l </span><span style="font-family: 標楷體; font-size: 9pt;">至少需含一種</span><b> </b></p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 11.4pt; margin: 1pt 2.85pt 0.5pt 11.9pt; layout-grid-mode: char;"><span style="font-family: wingdings; font-size: 11pt;">l </span><span style="font-family: 標楷體; font-size: 9pt;">第一組製劑最多可配合三種成分</span><b> </b></p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 11.4pt; margin: 0cm 2.85pt 1pt 11.9pt; layout-grid-mode: char;"><span style="font-family: wingdings; font-size: 11pt;">l </span><span style="font-family: 標楷體; font-size: 9pt;">第二組製劑最多可配合二種成分</span><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 81pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1.5pt double; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 11.4pt; margin: 1pt 5.65pt; layout-grid-mode: char;"><span style="font-size: 9pt;">2</span><span style="font-family: 標楷體; font-size: 9pt;">項</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 27pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt; layout-grid-mode: char;"><span style="font-family: 標楷體; font-size: 9pt;">◎</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 27pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt; layout-grid-mode: char;"><span style="font-family: 標楷體; font-size: 9pt;">◎</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 81pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1.5pt double; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 11.4pt; margin: 1pt 5.65pt; layout-grid-mode: char;"><span style="font-size: 9pt;">3</span><span style="font-family: 標楷體; font-size: 9pt;">項</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 27pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt; layout-grid-mode: char;"><span style="font-family: 標楷體; font-size: 9pt;">◎</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 27pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt; layout-grid-mode: char;"><span style="font-size: 9pt;">&times;</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 54pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 11.4pt; margin: 1pt 1.4pt;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 11.4pt; margin: 1pt 1.4pt;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt;"><b></b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 18pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt; layout-grid-mode: char;"><b><span style="font-size: 9pt;">B<br /> </span></b><b><span style="font-family: 標楷體; font-size: 9pt;">欄</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 81pt; padding-right: 0cm; border-right-color: #f0f0f0; border-left-color: #f0f0f0; padding-top: 0cm;" colspan="2"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 11.4pt; margin: 1pt 5.65pt; layout-grid-mode: char;"><b><span style="font-family: 標楷體; font-size: 9pt;">咖啡因</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1.5pt double; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 27pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt; layout-grid-mode: char;"><b><span style="font-size: 9pt;">○</span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 54pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 11.4pt; margin: 1pt 1.4pt;"><b><span style="letter-spacing: -0.2pt; font-size: 9pt;">1</span></b><b><span style="letter-spacing: -2pt; font-family: 標楷體; font-size: 9pt;">≧</span></b><b> </b><b><span style="letter-spacing: -0.2pt; font-family: 標楷體; font-size: 9pt;">≧</span></b><b><span style="letter-spacing: -0.2pt; font-size: 9pt;">1/5</span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt;"><b></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt;"><b></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 27pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt; layout-grid-mode: char;"><b><span style="font-size: 9pt;">○</span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 54pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 11.4pt; margin: 1pt 1.4pt;"><b><span style="letter-spacing: -0.2pt; font-size: 9pt;">1</span></b><b><span style="letter-spacing: -2pt; font-family: 標楷體; font-size: 9pt;">≧</span></b><b> </b><b><span style="letter-spacing: -0.2pt; font-family: 標楷體; font-size: 9pt;">≧</span></b><b><span style="letter-spacing: -0.2pt; font-size: 9pt;">1/5</span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt;"><b></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt;"><b></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 270pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 11.4pt; margin: 0cm 2.85pt 1pt; layout-grid-mode: char;"><b><span style="font-family: 標楷體; font-size: 9pt;">最多配合一種成分</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 18pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 0cm; layout-grid-mode: char;"><b><span style="font-size: 9pt;">C</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">欄</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 18pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt; layout-grid-mode: char;"><b><span style="letter-spacing: -1pt; font-size: 9pt;">1</span></b><b><span style="letter-spacing: -1pt; font-family: 標楷體; font-size: 9pt;">項</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt;"><b><span style="font-size: 9pt;">Vitamin B<sub>1</sub></span></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 27pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt; layout-grid-mode: char;"><b><span style="font-size: 9pt;">○</span></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 54pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">從表一</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt;"><b><span style="font-size: 9pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">從表一</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 27pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt; layout-grid-mode: char;"><b><span style="font-size: 9pt;">○</span></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 54pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">從表一</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt;"><b><span style="font-size: 9pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">從表一</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 270pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 11.4pt; margin: 1pt 2.85pt 0.5pt; layout-grid-mode: char;"><b><span style="font-size: 9pt;">&ldquo;</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">從表一</span></b><b><span style="font-size: 9pt;">&rdquo;</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">：從表一一日配合量上下限之規定</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 18pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt; layout-grid-mode: char;"><b><span style="letter-spacing: -1pt; font-size: 9pt;">2</span></b><b><span style="letter-spacing: -1pt; font-family: 標楷體; font-size: 9pt;">項</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt;"><b><span style="font-size: 9pt;">Vitamin B<sub>2</sub></span></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 27pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt; layout-grid-mode: char;"><b><span style="font-size: 9pt;">○</span></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 54pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">從表一</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt;"><b><span style="font-size: 9pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">從表一</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 27pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt; layout-grid-mode: char;"><b><span style="font-size: 9pt;">○</span></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 54pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">從表一</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt;"><b><span style="font-size: 9pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">從表一</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 18pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt; layout-grid-mode: char;"><b><span style="letter-spacing: -1pt; font-size: 9pt;">3</span></b><b><span style="letter-spacing: -1pt; font-family: 標楷體; font-size: 9pt;">項</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt;"><b><span style="font-size: 9pt;">Vitamin C</span></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 27pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt; layout-grid-mode: char;"><b><span style="font-size: 9pt;">○</span></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 54pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">從表一</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt;"><b><span style="font-size: 9pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">從表一</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 27pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt; layout-grid-mode: char;"><b><span style="font-size: 9pt;">○</span></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 54pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">從表一</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt;"><b><span style="font-size: 9pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">從表一</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1.5pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 18pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt; layout-grid-mode: char;"><b><span style="font-size: 9pt;">D<br /> </span></b><b><span style="font-family: 標楷體; font-size: 9pt;">欄</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 81pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 11.4pt; margin: 1pt 5.65pt; layout-grid-mode: char;"><b><span style="font-family: 標楷體; font-size: 9pt;">生藥</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 27pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt; layout-grid-mode: char;"><b><span style="font-size: 9pt;">○</span></b></p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 54pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 11.4pt; margin: 1pt 1.4pt;"><b><span style="letter-spacing: -0.5pt; font-size: 9pt;">1</span></b><b><span style="letter-spacing: -2.2pt; font-family: 標楷體; font-size: 9pt;">≧</span></b><b> </b><b><span style="letter-spacing: -0.5pt; font-family: 標楷體; font-size: 9pt;">≧</span></b><b><span style="letter-spacing: -0.5pt; font-size: 9pt;">1/1</span></b><b><span style="font-size: 9pt;">0 </span></b></p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt;"><b><span style="letter-spacing: -0.5pt; font-size: 9pt;">1</span></b><b><span style="letter-spacing: -2.2pt; font-family: 標楷體; font-size: 9pt;">≧</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt;"><b><span style="letter-spacing: -0.5pt; font-size: 9pt;">1/1</span></b><b><span style="font-size: 9pt;">0</span></b></p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 27pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt; layout-grid-mode: char;"><b><span style="font-size: 9pt;">○</span></b></p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 54pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 11.4pt; margin: 1pt 1.4pt;"><b><span style="letter-spacing: -0.5pt; font-size: 9pt;">1</span></b><b><span style="letter-spacing: -2.2pt; font-family: 標楷體; font-size: 9pt;">≧</span></b><b> </b><b><span style="letter-spacing: -0.5pt; font-family: 標楷體; font-size: 9pt;">≧</span></b><b><span style="letter-spacing: -0.5pt; font-size: 9pt;">1/1</span></b><b><span style="font-size: 9pt;">0 </span></b></p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt;"><b><span style="letter-spacing: -0.5pt; font-size: 9pt;">1</span></b><b><span style="letter-spacing: -2.2pt; font-family: 標楷體; font-size: 9pt;">≧</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt;"><b><span style="letter-spacing: -0.5pt; font-size: 9pt;">1/1</span></b><b><span style="font-size: 9pt;">0</span></b></p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 270pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 11.4pt; margin: 0cm 2.85pt 1pt; layout-grid-mode: char;"><b><span style="font-family: 標楷體; font-size: 9pt;">第二組製劑配合</span></b><b><span style="font-size: 9pt;">F</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">欄成分時，須檢附十大先進國中一國以上採用之處方依據</span></b><b> </b></p> </td> </tr> </tbody></table><p style="line-height: 11.5pt; margin: 3pt 0cm 0pt; layout-grid-mode: char;"><span style="font-family: 標楷體; font-size: 11pt;">◎</span><span style="font-family: 標楷體; font-size: 11pt;">：必須配合成分</span><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp; ○</span><span style="font-family: 標楷體; font-size: 11pt;">：可配合成分</span> </p> 2013-12-04
1420513 查驗登記類,指示藥品審查基準,綜合感冒藥 行政解釋 指示藥品審查基準-綜合感冒劑 詳如附件 2013-12-04 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4511&type=0
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1420515 查驗登記類,指示藥品審查基準,瀉藥 行政解釋 指示藥品審查基準-瀉劑 <p style="text-align: center;"><span style="font-family: 新細明體,serif; font-size: 14pt;">瀉</span> <span style="font-family: 新細明體,serif; font-size: 14pt;">　劑</span><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">壹、適用範圍</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 67: ;"><span style="font-family: 新細明體,serif;">一、凡用以<b>軟便或</b>緩解便祕為目的<b>之</b>內服<b>製</b>劑<b>或栓劑</b>，均適用本基準。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 67: ;"><b><span style="font-family: 新細明體,serif;">二、僅以本基準所列之</span>A</b><b><span style="font-family: 新細明體,serif;">欄</span>1</b><b><span style="font-family: 新細明體,serif;">項（</span>c</b><b><span style="font-family: 新細明體,serif;">）、</span>C</b><b><span style="font-family: 新細明體,serif;">欄及</span>D</b><b><span style="font-family: 新細明體,serif;">欄生藥成分為製劑者，不適用本基準。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">貳、有效成分</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 36pt: ;"><b><span style="font-family: 新細明體,serif;">一、有效成分之種類及含量：</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 62: ;"><b>(</b><b><span style="font-family: 新細明體,serif;">一</span>) </b><b><span style="font-family: 新細明體,serif;">本基準可配合之有效成分，記載於表一。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 98: ;"><b>(</b><b><span style="font-family: 新細明體,serif;">二</span>) </b><b><span style="font-family: 新細明體,serif;">表一規定</span>A</b><b><span style="font-family: 新細明體,serif;">欄中各有效成分之</span>1</b><b><span style="font-family: 新細明體,serif;">次最大配合量及一日最大配合量；</span>B</b><b><span style="font-family: 新細明體,serif;">欄各有效成分之</span>1</b><b><span style="font-family: 新細明體,serif;">次配合量上下限及一日最大配合量；</span>C</b><b><span style="font-family: 新細明體,serif;">欄及</span>D</b><b><span style="font-family: 新細明體,serif;">欄中各有效成分之一日最大配合量。</span></b> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 36pt: ;"><span style="font-family: 新細明體,serif;">表一、有效成分之種類</span> </p><div style="text-align: center;"><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0" width="600"> <tbody> <tr style="page-break-inside: avoid; height: 31.15pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; height: 31.15pt; padding-top: 0cm;border: windowtext 1pt solid;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt 0cm; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">欄</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; height: 31.15pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">項</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; height: 31.15pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">有</span> &nbsp;<span style="font-family: 新細明體,serif;">效</span> &nbsp;<span style="font-family: 新細明體,serif;">成</span> &nbsp;<span style="font-family: 新細明體,serif;">分</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 122.3pt; padding-right: 1.4pt; height: 31.15pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt; layout-grid-mode: char;">1<span style="font-family: 新細明體,serif;">次最大</span> </p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">配合量</span>(g)</p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 121.5pt; padding-right: 1.4pt; height: 31.15pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt 0cm; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">一日最大</span> </p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt 0cm; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">配合量</span>(g)</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom-color: #f0f0f0; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="7"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span>A<b> </b></span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="7"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">1</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt 0cm; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">（</span>a</b><b><span style="font-family: 新細明體,serif;">）</span></b>Bisacodyl</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 122.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt; layout-grid-mode: char;">0.015</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 121.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt; layout-grid-mode: char;">0.015</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">（</span>b</b><b><span style="font-family: 新細明體,serif;">）</span><span>Sennosides<sup> *2</sup></span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 122.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt; layout-grid-mode: char;">0.024</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 121.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt; layout-grid-mode: char;">0.024</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">有</span> &nbsp;<span style="font-family: 新細明體,serif;">效</span> &nbsp;<span style="font-family: 新細明體,serif;">成</span> &nbsp;<span style="font-family: 新細明體,serif;">分</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 122.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt; layout-grid-mode: char;">1<span style="font-family: 新細明體,serif;">次最大</span><sup>*1</sup> </p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">配合量</span>(g)</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 121.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt 0cm; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">一日最大</span><sup>*1</sup> </p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">配合量</span>(g)</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 63.8pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">浸膏</span> </p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; -0: ;">(<span style="font-family: 新細明體,serif;">原生藥換算量</span>)</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 58.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">粉末</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 67.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">浸膏</span> </p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">(<span style="font-family: 新細明體,serif;">原生藥換算量</span>)</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 54pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">粉末</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">（</span>c</b><b><span style="font-family: 新細明體,serif;">）生藥</span> </b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 122.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b></b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 121.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b></b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>Aloe </b><b><span style="font-family: 新細明體,serif;">蘆薈</span> </b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 63.8pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>0.38</b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 58.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>0.38</b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 67.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>0.75</b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 54pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>0.75</b></p> </td> </tr> <tr style="page-break-inside: avoid; height: 17.65pt;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; height: 17.65pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>Cascara Sagrada </b><b><span style="font-family: 新細明體,serif;">美鼠李</span> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 63.8pt; padding-right: 1.4pt; height: 17.65pt; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>1.5</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 58.5pt; padding-right: 1.4pt; height: 17.65pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">―</span> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 67.5pt; padding-right: 1.4pt; height: 17.65pt; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>3</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 54pt; padding-right: 1.4pt; height: 17.65pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">―</span> </b></p> </td> </tr> <tr style="page-break-inside: avoid; height: 23.75pt;"> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; height: 23.75pt; border-right-color: #f0f0f0; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: windowtext; padding-left: 1.4pt; width: 18pt; layout-flow: vertical-ideographic; padding-right: 1.4pt; border-top-width: 1pt; height: 23.75pt; border-right-color: #f0f0f0; border-left-color: #f0f0f0; padding-top: 0cm;" valign="bottom"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b></b></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; height: 23.75pt; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b></b></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 63.8pt; padding-right: 1.4pt; height: 23.75pt; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b></b></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 58.5pt; padding-right: 1.4pt; height: 23.75pt; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b></b></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 67.5pt; padding-right: 1.4pt; height: 23.75pt; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b></b></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 54pt; padding-right: 1.4pt; height: 23.75pt; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b></b></p> </td> </tr> <tr style="page-break-inside: avoid; height: 36.25pt;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 450pt; padding-right: 1.4pt; height: 36.25pt; border-right-color: #f0f0f0; border-left-color: #f0f0f0; padding-top: 0cm;" valign="bottom" colspan="7"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">表一、有效成分之種類（續）</span><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt 0cm; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">欄</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">項</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">有</span> &nbsp;<span style="font-family: 新細明體,serif;">效</span> &nbsp;<span style="font-family: 新細明體,serif;">成</span> &nbsp;<span style="font-family: 新細明體,serif;">分</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 122.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt; layout-grid-mode: char;">1<span style="font-family: 新細明體,serif;">次最大</span><sup>*1</sup> </p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">配合量</span>(g)</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 121.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt 0cm; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">一日最大</span><sup>*1</sup> </p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">配合量</span>(g)</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 63.8pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">浸膏</span> </p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">(<span style="font-family: 新細明體,serif;">原生藥換算量</span>)</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 58.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">粉末</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 67.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">浸膏</span> </p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">(<span style="font-family: 新細明體,serif;">原生藥換算量</span>)</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 54pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">粉末</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="13"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">A</p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="7"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">1</p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">（</span>c</b><b><span style="font-family: 新細明體,serif;">）生藥</span> </b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 122.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b></b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 121.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b></b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>Frangula Bark </b><b><span style="font-family: 新細明體,serif;">歐鼠李皮</span> </b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 63.8pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>1.5</b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 58.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">―</span> </b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 67.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>3</b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 54pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">―</span> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>Pharbitidis Semen </b><b><span style="font-family: 新細明體,serif;">牽牛子</span> </b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 63.8pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">―</span> </b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 58.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>0.1</b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 67.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">―</span> </b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 54pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>0.3</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>Rhei Rhizoma </b><b><span style="font-family: 新細明體,serif;">大黃</span> </b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 63.8pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>2</b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 58.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>1.5</b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 67.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>4</b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 54pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>3</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>Rosae Fructus </b><b><span style="font-family: 新細明體,serif;">營實</span> </b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 63.8pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>1.7</b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 58.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>0.67</b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 67.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>5</b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 54pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>2</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>Sennae Folium </b><b><span style="font-family: 新細明體,serif;">番瀉葉</span> </b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 63.8pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>3</b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 58.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>0.75</b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 67.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>6</b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 54pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>1.5</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>Sennae Fructus </b><b><span style="font-family: 新細明體,serif;">番瀉果</span> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 63.8pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">―</span> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 58.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>0.75</b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 67.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">―</span> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 54pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>1.5</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">項</span><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">有</span> &nbsp;<span style="font-family: 新細明體,serif;">效</span> &nbsp;<span style="font-family: 新細明體,serif;">成</span> &nbsp;<span style="font-family: 新細明體,serif;">分</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 122.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt; layout-grid-mode: char;">1<span style="font-family: 新細明體,serif;">次最大</span> </p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">配合量</span>(g)</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 121.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt 0cm; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">一日最大</span> </p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt 0cm; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">配合量</span>(g)</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">2</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">Magnesium hydroxide</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 122.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">0.5</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 121.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">2.1</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">Magnesium oxide</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 122.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">0.5</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 121.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">2</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">3</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">Calcium polycarbophil</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 122.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">1</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 121.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">6</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span>Psyllium <b>Husk<sup>*3</sup></b></span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 122.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">3.4</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 121.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">10</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">4</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 3: ;"><span>Docusate sodium (Dioctyl sodium sulfosuccinate; DSS)<b></b></span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 122.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span>0.2<br /> <b>(0.12)<sup>*4</sup></b></span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 121.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">0.2</p> </td> </tr> <tr style="page-break-inside: avoid; height: 18pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; height: 18pt; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">欄</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; height: 18pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">項</span><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; height: 18pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">有</span> &nbsp;<span style="font-family: 新細明體,serif;">效</span> &nbsp;<span style="font-family: 新細明體,serif;">成</span> &nbsp;<span style="font-family: 新細明體,serif;">分</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 122.3pt; padding-right: 1.4pt; height: 18pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt; layout-grid-mode: char;">1<span style="font-family: 新細明體,serif;">次</span> </p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">配合量</span>(g)</p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 121.5pt; padding-right: 1.4pt; height: 18pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt 0cm; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">一日最大</span> </p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt 0cm; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">配合量</span>(g)</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">B</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">1</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">Bisacodyl</p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 122.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt; layout-grid-mode: char;"><b>0.005</b><b><span style="font-family: 新細明體,serif;">－</span></b>0.01</p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 121.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt; layout-grid-mode: char;">0.01</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">2</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">Glycerin</p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 122.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>1.5</b><b><span style="font-family: 新細明體,serif;">－</span></b>3</p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 121.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">3</p> </td> </tr> <tr style="page-break-inside: avoid; height: 23.3pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; height: 23.3pt; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">欄</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; height: 23.3pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">項</span><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; height: 23.3pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">有</span> &nbsp;<span style="font-family: 新細明體,serif;">效</span> &nbsp;<span style="font-family: 新細明體,serif;">成</span> &nbsp;<span style="font-family: 新細明體,serif;">分</span><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243.8pt; padding-right: 1.4pt; height: 23.3pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="4"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">一日最大配合量</span><span>(g)<sup> *1</sup><b></b></span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 4.2pt;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 122.3pt; padding-right: 1.4pt; height: 4.2pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">浸膏</span> </p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">（原生藥換算量）</span><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 121.5pt; padding-right: 1.4pt; height: 4.2pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">粉末</span><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <h1 style="line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: times new roman,serif; font-size: 11pt;">C</span></b></h1> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>Glycyrrhizae Radix </b><b><span style="font-family: 新細明體,serif;">甘草</span> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 122.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>5</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 121.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>1.5</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>Moutan Cortex </b><b><span style="font-family: 新細明體,serif;">牡丹皮</span> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 122.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>4</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 121.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>1.3</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>Smilacis Rhizoma </b><b><span style="font-family: 新細明體,serif;">土茯苓</span> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 122.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>5</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 121.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>1.5</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="5"> <h1 style="line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: times new roman,serif; font-size: 11pt;">D</span></b></h1> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="5"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>Cinnamomi Cortex </b><b><span style="font-family: 新細明體,serif;">桂皮</span> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 122.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>2.5</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 121.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>0.5</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>Coptidis Rhizoma </b><b><span style="font-family: 新細明體,serif;">黃連</span> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 122.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>1.5</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 121.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>0.75</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>Foeniculi Fructus </b><b><span style="font-family: 新細明體,serif;">小茴香</span> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 122.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>1.5</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 121.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>0.5</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>Magnoliae Cortex </b><b><span style="font-family: 新細明體,serif;">厚朴</span> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 122.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>2.5</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 121.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>0.75</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>Scutellariae Radix </b><b><span style="font-family: 新細明體,serif;">黃苓</span> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 122.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>3</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 121.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>1.5</b></p> </td> </tr> </tbody></table></div><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 74: ;"><b>*1. </b><b><span style="font-family: 新細明體,serif;">同一成分之浸膏與粉末不可同時使用。浸膏（或粉末）欄內若無</span>1</b><b><span style="font-family: 新細明體,serif;">次最大配合量及一日最大配合量規定時，則該成分不得以浸膏（或粉末）配合使用。浸膏之</span>1</b><b><span style="font-family: 新細明體,serif;">次最大配合量及一日最大配合量係以原生藥經抽提製成浸膏所用的原生藥量表示之。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 72pt: ;"><b>*2. Sennosides</b><b><span style="font-family: 新細明體,serif;">所定之</span>1</b><b><span style="font-family: 新細明體,serif;">次最大配合量及一日最大配合量，以其所含之</span>Sennoside A</b><b><span style="font-family: 新細明體,serif;">、</span>Sennoside B</b><b><span style="font-family: 新細明體,serif;">或</span>Sennoside A</b><b><span style="font-family: 新細明體,serif;">＆</span>B</b><b><span style="font-family: 新細明體,serif;">定量之（不含鹽基）。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 73: ;"><b>*3. Psyllium Husk</b><b><span style="font-family: 新細明體,serif;">：包括</span><i>Plantago ovata </i>[Blond Psyllium</b><b><span style="font-family: 新細明體,serif;">或</span>Indian Psyllium</b><b><span style="font-family: 新細明體,serif;">或</span>Ispaghula]</b><b><span style="font-family: 新細明體,serif;">、</span><i>Plantago psyllium</i></b><b><span style="font-family: 新細明體,serif;">及</span><i>Plantago indica</i><span> (<i>Plantago arenaria) </i>[ Spanish or French Psyllium (Fam. Plantaginaceae)]</span></b><b><span style="font-family: 新細明體,serif;">的種皮。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 73: ;"><b>*4. </b><b><span style="font-family: 新細明體,serif;">內服製劑同時配合</span>A</b><b><span style="font-family: 新細明體,serif;">欄</span>4</b><b><span style="font-family: 新細明體,serif;">項</span>Docusate sodium (Dioctyl sodium sulfosuccinate; DSS)</b><b><span style="font-family: 新細明體,serif;">及</span>A</b><b><span style="font-family: 新細明體,serif;">欄其他有效成分且用法用量為一日</span>1</b><b><span style="font-family: 新細明體,serif;">次時，計算該欄配合係數及</span>Docusate sodium</b><b><span style="font-family: 新細明體,serif;">每日最高劑量之下限所使用之</span>Docusate sodium 1</b><b><span style="font-family: 新細明體,serif;">次最大配合量以</span>0.12 g</b><b><span style="font-family: 新細明體,serif;">為準。</span></b> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 36pt: ;"><b><span style="font-family: 新細明體,serif;">二、配合規則（見表二）</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 40: ;"><b><span>&nbsp;(</span></b><b><span style="font-family: 新細明體,serif;">一</span>) </b><b><span style="font-family: 新細明體,serif;">內服製劑：</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 117pt: ;"><b>1</b><b><span style="font-family: 新細明體,serif;">、必須配合成分：指表一</span>A</b><b><span style="font-family: 新細明體,serif;">欄</span>1</b><b><span style="font-family: 新細明體,serif;">項、</span>2</b><b><span style="font-family: 新細明體,serif;">項、</span>3</b><b><span style="font-family: 新細明體,serif;">項及</span>4</b><b><span style="font-family: 新細明體,serif;">項中所含之有效成分；配方中至少需含一種必須配合成分。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 117pt: ;"><b>2</b><b><span style="font-family: 新細明體,serif;">、可配合成分：指表一</span>C</b><b><span style="font-family: 新細明體,serif;">欄及</span>D</b><b><span style="font-family: 新細明體,serif;">欄中所含之有效成分。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 117pt: ;"><b>3</b><b><span style="font-family: 新細明體,serif;">、除另有規定外，上述</span>1</b><b><span style="font-family: 新細明體,serif;">之必須配合成分可相互配合使用，亦可與上述</span>2</b><b><span style="font-family: 新細明體,serif;">之可配合成分複方配合使用。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 117pt: ;"><b>4</b><b><span style="font-family: 新細明體,serif;">、表一</span>A</b><b><span style="font-family: 新細明體,serif;">欄</span>3</b><b><span style="font-family: 新細明體,serif;">項之</span>Calcium polycarbophil</b><b><span style="font-family: 新細明體,serif;">限為單方製劑。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 116: ;"><b>5</b><b><span style="font-family: 新細明體,serif;">、</span>A</b><b><span style="font-family: 新細明體,serif;">欄</span>1</b><b><span style="font-family: 新細明體,serif;">項有效成分中，</span>Sennae Folium(</b><b><span style="font-family: 新細明體,serif;">番瀉葉</span>)</b><b><span style="font-family: 新細明體,serif;">或</span>Sennae Fructus(</b><b><span style="font-family: 新細明體,serif;">番瀉果</span>) </b><b><span style="font-family: 新細明體,serif;">不可與</span>Sennosides</b><b><span style="font-family: 新細明體,serif;">同時配合使用，但</span>Sennae Folium(</b><b><span style="font-family: 新細明體,serif;">番瀉葉</span>)</b><b><span style="font-family: 新細明體,serif;">與</span>Sennae Fructus(</b><b><span style="font-family: 新細明體,serif;">番瀉果</span>) </b><b><span style="font-family: 新細明體,serif;">可同時配合使用。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 116: ;"><b>6</b><b><span style="font-family: 新細明體,serif;">、必須配合成分中，</span>A</b><b><span style="font-family: 新細明體,serif;">欄</span>1</b><b><span style="font-family: 新細明體,serif;">項最多可同時配合四種有效成分；</span>A</b><b><span style="font-family: 新細明體,serif;">欄</span>2</b><b><span style="font-family: 新細明體,serif;">項、</span>3</b><b><span style="font-family: 新細明體,serif;">項及</span>4</b><b><span style="font-family: 新細明體,serif;">項中各項最多可配合一種有效成分。但所有的必須配合成分最多只可同時配合四種。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 116: ;"><b>7</b><b><span style="font-family: 新細明體,serif;">、可配合成分中，</span>C</b><b><span style="font-family: 新細明體,serif;">欄最多可同時配合三種有效成分；</span>D</b><b><span style="font-family: 新細明體,serif;">欄最多可同時配合四種有效成分。但所有的可配合成分最多只可同時配合五種。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 116: ;"><b>8</b><b><span style="font-family: 新細明體,serif;">、製劑中含生藥成分者（表一</span>A</b><b><span style="font-family: 新細明體,serif;">欄</span>1</b><b><span style="font-family: 新細明體,serif;">項（</span>c</b><b><span style="font-family: 新細明體,serif;">）、</span>C</b><b><span style="font-family: 新細明體,serif;">欄及</span>D</b><b><span style="font-family: 新細明體,serif;">欄），應做生藥成分之定性試驗；對於藥典等公定書所收載之生藥有指標成分定量者，應做定量試驗。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 54pt: ;"><b>(</b><b><span style="font-family: 新細明體,serif;">二</span>) </b><b><span style="font-family: 新細明體,serif;">栓劑：</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 85: ;"><b>1</b><b><span style="font-family: 新細明體,serif;">、必須配合成分：指表一</span>B</b><b><span style="font-family: 新細明體,serif;">欄</span>1</b><b><span style="font-family: 新細明體,serif;">項及</span>2</b><b><span style="font-family: 新細明體,serif;">項中之有效成分。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 85: ;"><b>2</b><b><span style="font-family: 新細明體,serif;">、限為單方製劑。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span>&nbsp;&nbsp;&nbsp; </span></b><b><span style="font-family: 新細明體,serif;">表二、配合規則及配合係數</span> </b></p><div style="text-align: center;"><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="page-break-inside: avoid; height: 24.5pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 112.5pt; padding-right: 1.4pt; height: 24.5pt; padding-top: 0cm;border: windowtext 1pt solid;" valign="top" rowspan="2" colspan="4"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 7.65pt 0pt 0cm; layout-grid-mode: char;"><b><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></b><b><span style="font-family: 新細明體,serif;">製</span> <span>&nbsp;&nbsp;&nbsp;</span></b><b><span style="font-family: 新細明體,serif;">劑</span> </b></p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span>&nbsp;</span></b><b><span style="font-family: 新細明體,serif;">有</span> </b><b><span style="font-family: 新細明體,serif;">效</span> </b><b><span style="font-family: 新細明體,serif;">成</span> </b><b><span style="font-family: 新細明體,serif;">分</span> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 58.5pt; padding-right: 1.4pt; height: 24.5pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">配合規則</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 56.8pt; padding-right: 1.4pt; height: 24.5pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">同欄成分</span> </b></p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">配合一種</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 109.7pt; padding-right: 1.4pt; height: 24.5pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">同欄成分</span> </b></p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">至少配合二種</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 133.3pt; padding-right: 1.4pt; height: 24.5pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">備</span><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></b><b><span style="font-family: 新細明體,serif;">註</span> </b></p> </td> </tr> <tr style="page-break-inside: avoid; height: 33pt;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 29.8pt; padding-right: 1.4pt; height: 33pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">內服</span> </b></p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">製劑</span> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 28.7pt; padding-right: 1.4pt; height: 33pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">栓劑</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 56.8pt; padding-right: 1.4pt; height: 33pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">配合係數</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 45pt; padding-right: 1.4pt; height: 33pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">配合係數</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 64.7pt; padding-right: 1.4pt; height: 33pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="letter-spacing: -1pt; font-family: 新細明體,serif;">各成分每日</span> </b></p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="letter-spacing: -1pt; font-family: 新細明體,serif;">最高劑量之下限</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid; height: 10.75pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; height: 10.75pt; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="6"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>A</b></p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">欄</span> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 22.5pt; padding-right: 1.4pt; height: 10.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>1</b><b><span style="font-family: 新細明體,serif;">項</span> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 54pt; padding-right: 1.4pt; height: 10.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">刺激性瀉藥</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; height: 10.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>(a)</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 29.8pt; padding-right: 1.4pt; height: 10.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="6"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">◎</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 28.7pt; padding-right: 1.4pt; height: 10.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="6"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>&times;</b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 56.8pt; padding-right: 1.4pt; height: 10.75pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="6"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>1</b><b><span style="font-family: 新細明體,serif;">≧≧</span>1/2</b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 45pt; padding-right: 1.4pt; height: 10.75pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="6"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>2</b><b><span style="font-family: 新細明體,serif;">≧≧</span>1/2</b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 64.7pt; padding-right: 1.4pt; height: 10.75pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>1/5</b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 90pt; padding-right: 1.4pt; height: 10.75pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt;"><b><span style="letter-spacing: -0.7pt; font-family: 標楷體; font-size: 11pt;">最多可配合四種成分</span></b><b> </b></p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 43.3pt; padding-right: 1.4pt; height: 10.75pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="6"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>A</b><b><span style="font-family: 新細明體,serif;">欄成分最多可同時配合四種成分</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid; height: 10.75pt;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; height: 10.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>(b)</b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 64.7pt; padding-right: 1.4pt; height: 10.75pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>1/5</b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid; height: 10.75pt;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; height: 10.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>(c)</b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 64.7pt; padding-right: 1.4pt; height: 10.75pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>1/10</b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid; height: 20pt;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 22.5pt; padding-right: 1.4pt; height: 20pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>2</b><b><span style="font-family: 新細明體,serif;">項</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 72pt; padding-right: 1.4pt; height: 20pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">鹽類瀉藥</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 64.7pt; padding-right: 1.4pt; height: 20pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>1/5</b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 90pt; padding-right: 1.4pt; height: 20pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt;"><b><span style="font-family: 標楷體; font-size: 11pt;">最多配合一種成分</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid; height: 20pt;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 22.5pt; padding-right: 1.4pt; height: 20pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>3</b><b><span style="font-family: 新細明體,serif;">項</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 72pt; padding-right: 1.4pt; height: 20pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">膨脹性瀉藥</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 64.7pt; padding-right: 1.4pt; height: 20pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>1/5</b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 90pt; padding-right: 1.4pt; height: 20pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="letter-spacing: -0.5pt; font-family: 新細明體,serif;">最多配合一種成分；</span> </b></p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="letter-spacing: -0.6pt;">Calcium polycarbophil</span></b><b><span style="font-family: 新細明體,serif;">限為單方製劑</span> </b></p> </td> </tr> <tr style="page-break-inside: avoid; height: 20pt;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 22.5pt; padding-right: 1.4pt; height: 20pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>4</b><b><span style="font-family: 新細明體,serif;">項</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 72pt; padding-right: 1.4pt; height: 20pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">溼潤性瀉藥</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 64.7pt; padding-right: 1.4pt; height: 20pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>1/5</b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 90pt; padding-right: 1.4pt; height: 20pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">最多配合一種成分</span> </b></p> </td> </tr> <tr style="page-break-inside: avoid; height: 20pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; height: 20pt; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>B</b></p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">欄</span> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 22.5pt; padding-right: 1.4pt; height: 20pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>1</b><b><span style="font-family: 新細明體,serif;">項</span> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 72pt; padding-right: 1.4pt; height: 20pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">刺激性瀉藥</span> </b></p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>Bisacodyl</b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 29.8pt; padding-right: 1.4pt; height: 20pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>&times;</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 28.7pt; padding-right: 1.4pt; height: 20pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">◎</span> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 56.8pt; padding-right: 1.4pt; height: 20pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">從表一</span> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 45pt; padding-right: 1.4pt; height: 20pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 64.7pt; padding-right: 1.4pt; height: 20pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 133.3pt; padding-right: 1.4pt; height: 20pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">限為單方製劑</span> </b></p> </td> </tr> <tr style="page-break-inside: avoid; height: 20pt;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 22.5pt; padding-right: 1.4pt; height: 20pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>2</b><b><span style="font-family: 新細明體,serif;">項</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 72pt; padding-right: 1.4pt; height: 20pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">高滲透壓瀉藥</span> </b></p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>Glycerin</b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid; height: 33pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; height: 33pt; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>C</b></p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">欄</span> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 94.5pt; padding-right: 1.4pt; height: 33pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="3"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">輔助緩和</span> </b></p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">瀉下成分</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 29.8pt; padding-right: 1.4pt; height: 33pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">○</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 28.7pt; padding-right: 1.4pt; height: 33pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>&times;</b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 56.8pt; padding-right: 1.4pt; height: 33pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>1</b><b><span style="font-family: 新細明體,serif;">≧≧</span>1/10</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 45pt; padding-right: 1.4pt; height: 33pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>2</b><b><span style="font-family: 新細明體,serif;">≧</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 64.7pt; padding-right: 1.4pt; height: 33pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>1/10</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 90pt; padding-right: 1.4pt; height: 33pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="letter-spacing: -0.7pt; font-family: 新細明體,serif;">最多可配合三種成分</span> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 43.3pt; padding-right: 1.4pt; height: 33pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 1: ;"><b>C</b><b><span style="font-family: 新細明體,serif;">欄及</span>D</b><b><span style="font-family: 新細明體,serif;">欄成分最多可同時配合五種成分</span> </b></p> </td> </tr> <tr style="page-break-inside: avoid; height: 33pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; height: 33pt; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>D</b></p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; -1: ;"><b><span style="font-family: 新細明體,serif;">欄</span> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 94.5pt; padding-right: 1.4pt; height: 33pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="3"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">健胃成分</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 29.8pt; padding-right: 1.4pt; height: 33pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">○</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 28.7pt; padding-right: 1.4pt; height: 33pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>&times;</b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 56.8pt; padding-right: 1.4pt; height: 33pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>1</b><b><span style="font-family: 新細明體,serif;">≧≧</span>1/5</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 45pt; padding-right: 1.4pt; height: 33pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>2</b><b><span style="font-family: 新細明體,serif;">≧≧</span>1/5</b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 64.7pt; padding-right: 1.4pt; height: 33pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">無設定</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 90pt; padding-right: 1.4pt; height: 33pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="letter-spacing: -0.7pt; font-family: 新細明體,serif;">最多可配合四種成分</span> </b></p> </td> </tr> </tbody></table></div><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></b><b><span style="font-family: 新細明體,serif;">◎：必須配合成分　　○：可配合成分　　</span>&times;</b><b><span style="font-family: 新細明體,serif;">：不可配合成分</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 31: ;"><b><span style="font-family: 新細明體,serif;">三、有效成分之配合量（見表二）</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 62: ;"><b>(</b><b><span style="font-family: 新細明體,serif;">一</span>) </b><b><span style="font-family: 新細明體,serif;">內服製劑</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 98: ;"><b>1</b><b><span style="font-family: 新細明體,serif;">、表一</span>A</b><b><span style="font-family: 新細明體,serif;">欄成分：</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 144pt: ;"><b><span style="font-family: 新細明體,serif;">（</span>1</b><b><span style="font-family: 新細明體,serif;">）各有效成分之每次最高配合劑量及每日最高劑量不得超過表一所列之</span>1</b><b><span style="font-family: 新細明體,serif;">次最大配合量及一日最大配合量。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 144pt: ;"><b><span style="font-family: 新細明體,serif;">（</span>2</b><b><span style="font-family: 新細明體,serif;">）同欄中配合一種有效成分時，該配合成分之配合係數應介於</span>1</b><b><span style="font-family: 新細明體,serif;">及</span>1/2</b><b><span style="font-family: 新細明體,serif;">之間。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 148: ;"><b><span style="font-family: 新細明體,serif;">（</span>3</b><b><span style="font-family: 新細明體,serif;">）同欄中配合二種或二種以上有效成分時，該欄之配合係數應介於</span>2</b><b><span style="font-family: 新細明體,serif;">及</span>1/2</b><b><span style="font-family: 新細明體,serif;">之間，且配合成分中含</span>A</b><b><span style="font-family: 新細明體,serif;">欄</span>1</b><b><span style="font-family: 新細明體,serif;">項（</span>a</b><b><span style="font-family: 新細明體,serif;">）、（</span>b</b><b><span style="font-family: 新細明體,serif;">）及</span>A</b><b><span style="font-family: 新細明體,serif;">欄</span>2</b><b><span style="font-family: 新細明體,serif;">項、</span>3</b><b><span style="font-family: 新細明體,serif;">項、</span>4</b><b><span style="font-family: 新細明體,serif;">項時，該項各配合成分每日最高劑量之配合係數下限不得小於</span>1/5</b><b><span style="font-family: 新細明體,serif;">，若配合成分中含</span>A</b><b><span style="font-family: 新細明體,serif;">欄</span>1</b><b><span style="font-family: 新細明體,serif;">項（</span>c</b><b><span style="font-family: 新細明體,serif;">）時，該項各配合成分每日最高劑量之配合係數下限不得小於</span>1/10</b><b><span style="font-family: 新細明體,serif;">。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 89: ;"><b>2</b><b><span style="font-family: 新細明體,serif;">、配方中含表一</span>C</b><b><span style="font-family: 新細明體,serif;">欄成分：</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 144pt: ;"><b><span style="font-family: 新細明體,serif;">（</span>1</b><b><span style="font-family: 新細明體,serif;">）各有效成分之每日最高劑量不得超過表一所列之一日最大配合量；配合</span>C</b><b><span style="font-family: 新細明體,serif;">欄時，各有效成分每次最高配合劑量不得超過表一所列一日最大配合量之</span>1/3</b><b><span style="font-family: 新細明體,serif;">。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 148: ;"><b><span style="font-family: 新細明體,serif;">（</span>2</b><b><span style="font-family: 新細明體,serif;">）同欄中配合一種有效成分時，該成分之配合係數應介於</span>1</b><b><span style="font-family: 新細明體,serif;">及</span>1/10</b><b><span style="font-family: 新細明體,serif;">之間。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 144pt: ;"><b><span style="font-family: 新細明體,serif;">（</span>3</b><b><span style="font-family: 新細明體,serif;">）同欄中配合二種或二種以上有效成分時，該欄之配合係數不可大於</span>2</b><b><span style="font-family: 新細明體,serif;">，且該欄各配合成分每日最高劑量之配合係數下限不得小於</span>1/10</b><b><span style="font-family: 新細明體,serif;">。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 89: ;"><b>3</b><b><span style="font-family: 新細明體,serif;">、配方中含表一</span>D</b><b><span style="font-family: 新細明體,serif;">欄成分：</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 144pt: ;"><b><span style="font-family: 新細明體,serif;">（</span>1</b><b><span style="font-family: 新細明體,serif;">）各有效成分之每日最高劑量不得超過表一所列之一日最大配合量；配合</span>D</b><b><span style="font-family: 新細明體,serif;">欄時，各有效成分每次最高配合劑量不得超過表一所列一日最大配合量之</span>1/3</b><b><span style="font-family: 新細明體,serif;">。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 144pt: ;"><b><span style="font-family: 新細明體,serif;">（</span>2</b><b><span style="font-family: 新細明體,serif;">）同欄中配合一種有效成分時，該成分之配合係數應介於</span>1</b><b><span style="font-family: 新細明體,serif;">及</span>1/5</b><b><span style="font-family: 新細明體,serif;">之間。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 144pt: ;"><b><span style="font-family: 新細明體,serif;">（</span>3</b><b><span style="font-family: 新細明體,serif;">）同欄中配合二種或二種以上有效成分時，該欄之配合係數應介於</span>2</b><b><span style="font-family: 新細明體,serif;">及</span>1/5</b><b><span style="font-family: 新細明體,serif;">之間。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 4cm: ;"><b>4</b><b><span style="font-family: 新細明體,serif;">、</span>A</b><b><span style="font-family: 新細明體,serif;">欄各成分配合係數之計算方式，依用法用量之不同有以下三種計算方式：</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 153pt: ;"><b><span style="font-family: 新細明體,serif;">（</span>1</b><b><span style="font-family: 新細明體,serif;">）一日</span>1</b><b><span style="font-family: 新細明體,serif;">次之用法：</span><span><br /></span></b><b><span style="font-family: 新細明體,serif;">所配合成分之每日最高劑量，除以該成分</span>1</b><b><span style="font-family: 新細明體,serif;">次最大配合量。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 153pt: ;"><b><span style="font-family: 新細明體,serif;">（</span>2</b><b><span style="font-family: 新細明體,serif;">）一日</span>1~2</b><b><span style="font-family: 新細明體,serif;">次之用法：</span><span><br /></span></b><b><span style="font-family: 新細明體,serif;">所配合成分之每日最高劑量，除以該成分</span>1</b><b><span style="font-family: 新細明體,serif;">次最大配合量乘以</span>2</b><b><span style="font-family: 新細明體,serif;">所得數值或該成分之一日最大配合量，擇兩者中數值較小者。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 153pt: ;"><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p><b><sub><span style="font-size: 14pt;">&nbsp;i = 1</span></sub></b></p> </div> </td> </tr> </tbody></table><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p><b><sub><span style="font-size: 14pt;">&nbsp;<span style="letter-spacing: -1pt;">&nbsp;</span>n</span></sub></b></p> </div> </td> </tr> </tbody></table><b><span style="font-family: 新細明體,serif;">（</span>3</b><b><span style="font-family: 新細明體,serif;">）一日</span>1~3</b><b><span style="font-family: 新細明體,serif;">次之用法：</span><span><br /></span></b><b><span style="font-family: 新細明體,serif;">所配合成分之每日最高劑量，除以該成分一日最大配合量。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 175: ;"><b><span style="font-family: 新細明體,serif;">配合係數</span> =</b><b><span style="font-family: 新細明體,serif;">&Sigma;</span><span>(X<sub>i</sub> / mX<sub>i</sub>)</span></b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 94: ;"><b><span style="letter-spacing: -1pt;">= (X<sub>1</sub> / mX<sub>1</sub>) + (X<sub>2</sub> / mX<sub>2</sub>) +&hellip;&hellip;+ (X<sub>n</sub> / mX<sub>n</sub>)</span></b></p><table style="margin: auto auto auto 145.4pt; border-collapse: collapse;" border="0" cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 49.5pt; padding-right: 1.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span>X<sub>i</sub></span></b><b><span style="font-family: 新細明體,serif;">：</span> </b></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 275.25pt; padding-right: 1.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">各欄配合成分</span>i</b><b><span style="font-family: 新細明體,serif;">之每日最高劑量</span> </b></p> </td> </tr> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 49.5pt; padding-right: 1.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span>mX<sub>i</sub></span></b><b><span style="font-family: 新細明體,serif;">：</span> </b></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 275.25pt; padding-right: 1.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">各欄配合成分</span>i</b><b><span style="font-family: 新細明體,serif;">之一日最大配合量</span> </b></p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 19: ;"><b><span style="font-family: 新細明體,serif;">（或</span>1</b><b><span style="font-family: 新細明體,serif;">次最大配合量、</span>1</b><b><span style="font-family: 新細明體,serif;">次最大配合量乘以</span>2</b><b><span style="font-family: 新細明體,serif;">，視用法用量而定）</span> </b></p> </td> </tr> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 49.5pt; padding-right: 1.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>n</b><b><span style="font-family: 新細明體,serif;">：</span> </b></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 275.25pt; padding-right: 1.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">各欄之配合成分數</span> </b></p> </td> </tr> </tbody></table><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 114: ;"><b>5</b><b><span style="font-family: 新細明體,serif;">、</span>k</b><b><span style="font-family: 新細明體,serif;">值（每日劑量範圍）之計算：</span><span><br /></span></b><b><span style="font-family: 新細明體,serif;">因應瀉劑之用法用量不同，需加入</span>k</b><b><span style="font-family: 新細明體,serif;">值之計算，以確認其每日最高及最低劑量範圍是否適當。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 197: ;"><b>k =</b><b><span style="font-family: 新細明體,serif;">配合成分之每日最高劑量</span> / </b><b><span style="font-family: 新細明體,serif;">配合成分之</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 197: ;"><b><span style="font-family: 新細明體,serif;">每日最低劑量</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 89: ;"><b>k</b><b><span style="font-family: 新細明體,serif;">值之允許範圍為</span>1</b><b><span style="font-family: 新細明體,serif;">＜</span>k</b><b><span style="font-family: 新細明體,serif;">≦</span>4 </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 99pt: ;"><b>6</b><b><span style="font-family: 新細明體,serif;">、</span>C</b><b><span style="font-family: 新細明體,serif;">欄及</span>D</b><b><span style="font-family: 新細明體,serif;">欄各成分配合係數之計算方式：</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 175: ;"><b><span style="font-family: 新細明體,serif;">配合係數</span> =</b><b><span style="font-family: 新細明體,serif;">&Sigma;</span><span>(X<sub>i</sub> / mX<sub>i</sub>)</span></b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 94: ;"><b><span style="letter-spacing: -1pt;">= (X<sub>1</sub> / mX<sub>1</sub>) + (X<sub>2</sub> / mX<sub>2</sub>) +&hellip;&hellip;+ (X<sub>n</sub> / mX<sub>n</sub>)</span></b></p><table style="margin: auto auto auto 145.4pt; border-collapse: collapse;" border="0" cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 49.5pt; padding-right: 1.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span>X<sub>i</sub></span></b><b><span style="font-family: 新細明體,serif;">：</span> </b></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 275.25pt; padding-right: 1.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">各欄配合成分</span>i</b><b><span style="font-family: 新細明體,serif;">之每日最高劑量</span> </b></p> </td> </tr> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 49.5pt; padding-right: 1.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span>mX<sub>i</sub></span></b><b><span style="font-family: 新細明體,serif;">：</span> </b></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 275.25pt; padding-right: 1.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">各欄配合成分</span>i</b><b><span style="font-family: 新細明體,serif;">之一日最大配合量</span> </b></p> </td> </tr> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 49.5pt; padding-right: 1.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>n</b><b><span style="font-family: 新細明體,serif;">：</span> </b></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 275.25pt; padding-right: 1.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">各欄之配合成分數</span> </b></p> </td> </tr> </tbody></table><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 62: ;"><b><span>&nbsp;(</span></b><b><span style="font-family: 新細明體,serif;">二</span>) </b><b><span style="font-family: 新細明體,serif;">栓劑</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 126pt: ;"><b>1</b><b><span style="font-family: 新細明體,serif;">、表一</span>B</b><b><span style="font-family: 新細明體,serif;">欄</span>1</b><b><span style="font-family: 新細明體,serif;">項及</span>2</b><b><span style="font-family: 新細明體,serif;">項各成分之</span>1</b><b><span style="font-family: 新細明體,serif;">次配合量上下限及一日最大配合量依表一之規定。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 98: ;"><b>2</b><b><span style="font-family: 新細明體,serif;">、無需計算配合係數及</span>k</b><b><span style="font-family: 新細明體,serif;">值。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">參、劑型</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 67: ;"><span style="font-family: 新細明體,serif;">一、限於錠劑、<b>膜衣錠、糖衣錠、</b>膠囊劑、<b>軟膠囊劑</b>、丸劑<b>、內服</b>液劑、散劑、<b>內服</b>顆粒劑、<b>細粒劑</b>。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 67: ;"><b><span style="font-family: 新細明體,serif;">二、內服液劑限使用於</span>A</b><b><span style="font-family: 新細明體,serif;">欄</span>2</b><b><span style="font-family: 新細明體,serif;">項鹽類瀉藥成分。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 36pt: ;"><b><span style="font-family: 新細明體,serif;">三、含</span>A</b><b><span style="font-family: 新細明體,serif;">欄</span>1</b><b><span style="font-family: 新細明體,serif;">項（</span>a</b><b><span style="font-family: 新細明體,serif;">）</span>Bisacodyl</b><b><span style="font-family: 新細明體,serif;">之內服製劑限為腸溶劑型。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 72pt: ;"><b><span style="font-family: 新細明體,serif;">四、含</span>B</b><b><span style="font-family: 新細明體,serif;">欄</span>1</b><b><span style="font-family: 新細明體,serif;">項</span></b>Bisacodyl<b><span style="font-family: 新細明體,serif;">及</span>B</b><b><span style="font-family: 新細明體,serif;">欄</span>2</b><b><span style="font-family: 新細明體,serif;">項</span></b>Glycerin<span style="font-family: 新細明體,serif;">得有栓劑。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">肆、適應症</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 36pt: ;"><b><span style="font-family: 新細明體,serif;">軟便。若配合成分中含</span>A</b><b><span style="font-family: 新細明體,serif;">欄</span>1</b><b><span style="font-family: 新細明體,serif;">項刺激性瀉藥成分，適應症可為</span></b><span style="font-family: 新細明體,serif;">緩解便祕</span><b><span style="font-family: 新細明體,serif;">。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">伍、用法用量</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 67: ;"><b><span style="font-family: 新細明體,serif;">一、各製劑用法用量之標示請參考表三。其中，內服製劑訂定用法用量時需規定每次使用劑量之上下限範圍</span>(</b><b><span style="font-family: 新細明體,serif;">如</span>1</b><b><span style="font-family: 新細明體,serif;">次○</span>~</b><b><span style="font-family: 新細明體,serif;">○</span>)</b><b><span style="font-family: 新細明體,serif;">。</span> </b></p><p style="line-height: 16pt; layout-grid-mode: char; 72pt: ;"><span style="font-family: 標楷體; font-size: 11pt;">二、年齡分配係數： </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 67: ;"><b>12</b><b><span style="font-family: 新細明體,serif;">歲以上，適用成人劑量。</span><span><br />6</span></b><b><span style="font-family: 新細明體,serif;">歲以上未滿</span>12</b><b><span style="font-family: 新細明體,serif;">歲，適用成人劑量之</span>1/2</b><b><span style="font-family: 新細明體,serif;">。</span><span><br />3</span></b><b><span style="font-family: 新細明體,serif;">歲以上未滿</span>6</b><b><span style="font-family: 新細明體,serif;">歲，適用成人劑量之</span>1/4</b><b><span style="font-family: 新細明體,serif;">。</span><span><br /></span></b><b><span style="font-family: 新細明體,serif;">未滿</span>3</b><b><span style="font-family: 新細明體,serif;">歲之嬰幼兒，請洽醫師診治，不宜自行使用。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 72pt: ;"><b><span style="font-family: 新細明體,serif;">三、若製劑中含</span>A</b><b><span style="font-family: 新細明體,serif;">欄</span>3</b><b><span style="font-family: 新細明體,serif;">項</span></b><span style="font-family: 新細明體,serif;">膨脹性瀉藥<b>成分，</b>每次服用至少須與</span><span>240 m<b>l</b></span><span style="font-family: 新細明體,serif;">水一起服用。</span><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 45: ;"><b><span style="font-family: 新細明體,serif;">四、腸溶製劑應整粒吞服，不得剝半或嚼碎。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 45: ;"><b><span style="font-family: 新細明體,serif;">五、栓劑不得剝半使用。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 24: ;"><b><span style="font-family: 新細明體,serif;">表三、用法用量</span> </b></p><table style="margin: auto auto auto 24pt; border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="page-break-inside: avoid;"> <td style="border-bottom-color: #f0f0f0; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 58.4pt; padding-right: 1.4pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">製</span><span>&nbsp;&nbsp;&nbsp; </span></b><b><span style="font-family: 新細明體,serif;">劑</span> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 405pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">用</span> </b><b><span style="font-family: 新細明體,serif;">法</span> </b><b><span style="font-family: 新細明體,serif;">用</span> </b><b><span style="font-family: 新細明體,serif;">量</span> </b></p> </td> </tr> <tr style="page-break-inside: avoid; height: 109.55pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 58.4pt; padding-right: 1.4pt; height: 109.55pt; padding-top: 0cm;border: windowtext 1pt solid;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 3.5pt 0pt 3.3pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">內</span><span>&nbsp;&nbsp;&nbsp; </span></b><b><span style="font-family: 新細明體,serif;">服</span> </b></p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 3.5pt 0pt 3.3pt; layout-grid-mode: char;"><b></b></p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 3.5pt 0pt 3.3pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">製</span><span>&nbsp;&nbsp;&nbsp; </span></b><b><span style="font-family: 新細明體,serif;">劑</span> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 405pt; padding-right: 1.4pt; height: 109.55pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 2.85pt 0pt 3.4pt; layout-grid-mode: char;"><b>(a) </b><b><span style="font-family: 新細明體,serif;">一日</span>1</b><b><span style="font-family: 新細明體,serif;">次，</span>1</b><b><span style="font-family: 新細明體,serif;">次○</span>~</b><b><span style="font-family: 新細明體,serif;">○，於睡前（或空腹時）服用。</span> </b></p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 2.85pt 0pt 21.1pt; layout-grid-mode: char;"><b>(b) </b><b><span style="font-family: 新細明體,serif;">一日</span>1~2</b><b><span style="font-family: 新細明體,serif;">次，</span>1</b><b><span style="font-family: 新細明體,serif;">次○</span>~</b><b><span style="font-family: 新細明體,serif;">○，一日以</span>2</b><b><span style="font-family: 新細明體,serif;">次為限，於早晚（或服用間隔須</span>4</b><b><span style="font-family: 新細明體,serif;">小時以上），空腹時</span>(</b><b><span style="font-family: 新細明體,serif;">或隨餐</span>)</b><b><span style="font-family: 新細明體,serif;">服用。</span> </b></p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 2.85pt 0pt 21.1pt; layout-grid-mode: char;"><b>(c) </b><b><span style="font-family: 新細明體,serif;">一日</span>1~3</b><b><span style="font-family: 新細明體,serif;">次，</span>1</b><b><span style="font-family: 新細明體,serif;">次○</span>~</b><b><span style="font-family: 新細明體,serif;">○，一日以</span>3</b><b><span style="font-family: 新細明體,serif;">次為限，服用間隔須</span>4</b><b><span style="font-family: 新細明體,serif;">小時以上，於飯前</span>(</b><b><span style="font-family: 新細明體,serif;">或隨餐</span>)</b><b><span style="font-family: 新細明體,serif;">服用。</span> </b></p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 2.85pt 0pt 3.4pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">以上三種用法，均須加註</span> "</b><b><span style="font-family: 新細明體,serif;">初次應使用最小劑量，再視通便情況增減用量</span>"</b><b><span style="font-family: 新細明體,serif;">。</span> </b></p> </td> </tr> <tr style="page-break-inside: avoid; height: 24.8pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 58.4pt; padding-right: 1.4pt; height: 24.8pt; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 2: ;"><b><span style="font-family: 新細明體,serif;">栓</span><span>&nbsp;&nbsp;&nbsp; </span></b><b><span style="font-family: 新細明體,serif;">劑</span> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 405pt; padding-right: 1.4pt; height: 24.8pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 3: ;"><b>1</b><b><span style="font-family: 新細明體,serif;">次使用</span>1</b><b><span style="font-family: 新細明體,serif;">個。（未見效果時，得再使用</span>1</b><b><span style="font-family: 新細明體,serif;">個。）</span><sup>*5</sup> </b></p> </td> </tr> </tbody></table><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 22: ;"><b>*5. </b><b><span style="font-family: 新細明體,serif;">請標明每日可使用個數。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">陸、注意事項</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 37: ;"><b><span style="font-family: 新細明體,serif;">一、為防止兒童誤食請妥善保管。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 37: ;"><span style="font-family: 新細明體,serif;">二、避免陽光直射，宜保存於陰涼之處。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 68: ;"><span style="font-family: 新細明體,serif;">三、除非<b>有醫師藥師藥劑生</b>指示，孕婦及授乳婦不建議自行使用。</span> </p><p style="line-height: 16pt;"><span style="font-family: 全真楷書; font-size: 11pt;">四、勿超過建議劑量，<b>若有不適情況產生，</b>應<b>停止使用並請教醫師藥師藥劑生</b>。</span><b> </b></p><p style="line-height: 16pt;"><span style="font-family: 全真楷書; font-size: 11pt;">五、液劑使用前須振搖均勻，並使用廠商所附量器量取藥量。</span> </p><p style="line-height: 16pt;"><b><span style="font-family: 全真楷書; font-size: 11pt;">六、栓劑限使用於肛門，若藥劑過軟時，請置於低溫待較硬後再使用。</span></b><b> </b></p><p style="line-height: 16pt;"><b><span style="font-family: 全真楷書; font-size: 11pt;">七、栓劑使用時，應待便意強度持續後再行排便。若使用後立即排便，可能將本藥完全排空而導致失效。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 63pt: ;"><span style="font-family: 新細明體,serif;">八、瀉劑不應長期使用，一旦排便正常，即應停藥。除非<b>有醫師藥師藥劑生</b>指示，不得連續使用一星期以上，應儘量以含纖維飲食，充分攝取水分及運動來改善便祕。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">柒、警語</span></b> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 70: ;"><b><span>一、<span style="font: 7pt times new roman;">&nbsp;&nbsp;&nbsp;&nbsp; </span></span></b><b><span style="font-family: 新細明體,serif;">除非有醫師藥師藥劑生指示，不得併用其他瀉劑。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 67: ;"><b><span style="font-family: 新細明體,serif;">二、除非有醫師藥師藥劑生指示，曾經因本類藥物引起過敏症狀者不得使用。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 67: ;"><b><span style="font-family: 新細明體,serif;">三、內服製劑使用期間，若有噁心、嘔吐、嚴重腹痛或發疹等過敏症狀時，應停止使用並請教醫師藥師藥劑生。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 67: ;"><span style="font-family: 新細明體,serif;">四、若有血便及自發性<b>腸道</b>出血狀況，應<b>立即停藥</b>就醫。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 67: ;"><b><span style="font-family: 新細明體,serif;">五、使</span></b><span style="font-family: 新細明體,serif;">用一星期後無效者，應<b>立即停藥</b>就醫。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 67: ;"><b><span style="font-family: 新細明體,serif;">六、使用期間會有腹瀉發生，若腹瀉持續不止或加劇的情況下，應停止使用並請教醫師藥師藥劑生。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 70: ;"><b><span style="font-family: 新細明體,serif;">七、</span></b><span style="font-family: 新細明體,serif;">除非<b>有醫師藥師藥劑生</b>指示<b>，未滿</b></span><b>3</b><span style="font-family: 新細明體,serif;">歲<b>之嬰幼兒</b>不得使用<b>。</b></span><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 70pt: ;"><b><span style="font-family: 新細明體,serif;">八、含</span></b><span style="font-family: 新細明體,serif;">刺激性瀉藥<b>成分（表一</b></span><b>A</b><b><span style="font-family: 新細明體,serif;">欄</span>1</b><b><span style="font-family: 新細明體,serif;">項及</span>B </b><b><span style="font-family: 新細明體,serif;">欄</span>1</b><b><span style="font-family: 新細明體,serif;">項）之本類製劑加入下述警語：</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 67: ;">(<span style="font-family: 新細明體,serif;">一</span>)<span style="font-family: 新細明體,serif;">禁止用於胃腸道阻塞、腹痛、嘔吐、噁心之患者。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 85: ;">(<span style="font-family: 新細明體,serif;">二</span>)<span style="font-family: 新細明體,serif;">長期使用會造成電解質不平衡與水分缺乏。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 85: ;">(<span style="font-family: 新細明體,serif;">三</span>)<b><span style="font-family: 新細明體,serif;">含</span> Bisacodyl</b><b><span style="font-family: 新細明體,serif;">之內服製劑加入下述警語：</span></b> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 89: ;"><b><span style="font-family: 新細明體,serif;">含</span> </b>Bisacodyl<b><span style="font-family: 新細明體,serif;">之腸溶製</span></b><span style="font-family: 新細明體,serif;">劑須整粒吞服，不得咬碎<b>或磨粉</b>，且使用藥前後一小時不得使用制酸劑或牛乳。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 67: ;">(<span style="font-family: 新細明體,serif;">四</span>)<b><span style="font-family: 新細明體,serif;">含</span>Senna</b><b><span style="font-family: 新細明體,serif;">類之本類製劑加入下述警語：</span></b> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 117pt: ;">1<span style="font-family: 新細明體,serif;">、</span>Senna<span style="font-family: 新細明體,serif;">類會使酸性尿呈黃、棕色，鹼性尿呈粉紅或紫紅色；且會使結腸<b>黏</b>膜變黑。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 117pt: ;"><b>2</b><b><span style="font-family: 新細明體,serif;">、本藥含</span>Senna</b><b><span style="font-family: 新細明體,serif;">類成分，若有皮膚紅、皮膚癢等過敏症狀時，應停止使用並請教醫師藥師藥劑生。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 85: ;"><b>(</b><b><span style="font-family: 新細明體,serif;">五</span>)</b><b><span style="font-family: 新細明體,serif;">含蘆薈之本類製劑加入下述警語：</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 89: ;"><b><span style="font-family: 新細明體,serif;">大量使用含蘆薈之製劑，會引起骨盆腔內之臟器充血，孕婦、經期中婦女及腎炎、痔瘡之患者應留意。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 85: ;"><b>(</b><b><span style="font-family: 新細明體,serif;">六</span>)</b><b><span style="font-family: 新細明體,serif;">含大黃之本類製劑加入下述警語：</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 89: ;"><b><span style="font-family: 新細明體,serif;">本藥含大黃成分，若有皮膚紅、皮膚癢等過敏症狀時，應停止使用並請教醫師藥師藥劑生。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 67: ;"><b><span style="font-family: 新細明體,serif;">九、含</span></b><span style="font-family: 新細明體,serif;">鹽類瀉藥<b>成分（表一</b></span><b>A</b><b><span style="font-family: 新細明體,serif;">欄</span>2</b><b><span style="font-family: 新細明體,serif;">項）之本類製劑加入下述警語：</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 90pt: ;">(<span style="font-family: 新細明體,serif;">一</span>)<span style="font-family: 新細明體,serif;">禁止用於胃腸道阻塞、腹痛、嘔吐、噁心之患者。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 89: ;">(<span style="font-family: 新細明體,serif;">二</span>)<span style="font-family: 新細明體,serif;">長期使用會造成電解質不平衡與水分缺乏。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 89: ;"><b>(</b><b><span style="font-family: 新細明體,serif;">三</span>)</b><b><span style="font-family: 新細明體,serif;">除非有醫師藥師藥劑生指示，腎臟功能障礙之病患請勿服用本藥。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm -10.2pt 0pt 67.5pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">十、含</span></b><span style="font-family: 新細明體,serif;">膨脹性瀉藥<b>成分（表一</b></span><b>A</b><b><span style="font-family: 新細明體,serif;">欄</span> 3</b><b><span style="font-family: 新細明體,serif;">項）之本類製劑加入下述警語：</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 85: ;">(<span style="font-family: 新細明體,serif;">一</span>)<span style="font-family: 新細明體,serif;">禁止用於胃腸道阻塞、腹痛、嘔吐、噁心、腸道潰瘍、狹窄或粘黏之患者。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 85: ;">(<span style="font-family: 新細明體,serif;">二</span>)<span style="font-family: 新細明體,serif;">需</span>12<span style="font-family: 新細明體,serif;">小時至三天才會發生作用。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 85: ;">(<span style="font-family: 新細明體,serif;">三</span>)<span style="font-family: 新細明體,serif;">不適用於須限制水份之患者。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 85: ;">(<span style="font-family: 新細明體,serif;">四</span>)<span style="font-family: 新細明體,serif;">使用時須依指示加<b>足量</b>水服用，<b>否則易</b>引起胸痛、嘔吐、口水過多、容易嗆到<b>等食道阻塞之症狀或徵候</b>，須<b>停止使用並請教醫師藥師藥劑生</b>。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm -10.2pt 0pt 67.5pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">十、含</span></b><span style="font-family: 新細明體,serif;">溼潤性瀉藥<b>成分（表一</b></span><b>A</b><b><span style="font-family: 新細明體,serif;">欄</span>4</b><b><span style="font-family: 新細明體,serif;">項）之本類製劑加入下述警語：</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 90pt: ;">(<span style="font-family: 新細明體,serif;">一</span>)<span style="font-family: 新細明體,serif;">禁止用於胃腸道阻塞、腹痛、嘔吐、噁心、腸道潰瘍、狹窄或粘黏之患者。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 90pt: ;">(<span style="font-family: 新細明體,serif;">二</span>)<span style="font-family: 新細明體,serif;">溼潤性瀉<b>藥成分</b>，不可與礦物油合用。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 90: ;">(<span style="font-family: 新細明體,serif;">三</span>)<span style="font-family: 新細明體,serif;">長期使用會造成電解質不平衡與水分缺乏。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 72pt: ;"><b><span style="font-family: 新細明體,serif;">十一、含</span></b><span style="font-family: 新細明體,serif;">高滲透壓瀉藥<b>成分（表一</b></span><b>B</b><b><span style="font-family: 新細明體,serif;">欄</span>2</b><b><span style="font-family: 新細明體,serif;">項）之本類製劑加入下述警語：</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 90: ;"><span style="font-family: 新細明體,serif;">禁止用於胃腸道阻塞、腹痛、嘔吐、噁心之患者。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 76: ;"><b><span style="font-family: 新細明體,serif;">十二、含甘草（表一</span>C</b><b><span style="font-family: 新細明體,serif;">欄）一日配合量超過</span>1 g</b><b><span style="font-family: 新細明體,serif;">（或浸膏之原生藥換算量為</span>1 g</b><b><span style="font-family: 新細明體,serif;">以上）之本類製劑加入下述警語：</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 94: ;"><b>(</b><b><span style="font-family: 新細明體,serif;">一</span>)</b><b><span style="font-family: 新細明體,serif;">除非有醫師藥師藥劑生指示，高齡者與有嚴重腹痛、噁心、嘔吐、水腫症狀及高血壓、心臟功能障礙、腎臟功能障礙之病患請勿服用本藥。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 94: ;"><b>(</b><b><span style="font-family: 新細明體,serif;">二</span>)</b><b><span style="font-family: 新細明體,serif;">服用中發現有尿量減少、面部或手足浮腫、眼皮沉重、手部僵硬，血壓升高、頭痛等現象，應立即停藥就醫。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 35: ;"><b><span style="font-family: 新細明體,serif;">十三、栓劑之本類製劑加入下述警語：</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 94: ;"><span style="font-family: 新細明體,serif;">會造成直腸刺激感<b>、腹部不適。</b></span> </p> 2013-12-04
1420516 查驗登記類,指示藥品審查基準,鎮咳祛痰劑 行政解釋 指示藥品審查基準鎮-咳祛痰劑 詳如附件 2013-12-04 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4513&type=0
1420517 查驗登記類,指示藥品審查基準,鎮暈劑 行政解釋 指示藥品審查基準-鎮暈劑 詳如附件 2013-12-04 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4514&type=0
1420518 臨床試驗類,研究用人體檢體採集與使用注意事項 行政解釋 研究用人體檢體採集與使用注意事項 <p style="text-align: center;"><b><span style="font-family: 標楷體; color: #333333; font-size: 14pt;">研究用人體檢體採集與使用注意事項 </span></b></p><p style="text-align: center;">&nbsp;</p><p><span style="font-family: 標楷體;">一、為確保研究用檢體之正當採集及使用，保障檢體提供者之權益，並促 </span></p><p><span style="font-family: 標楷體;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體;">進科學之正當發展，特訂定本注意事項。 </span></p><p><span style="font-family: 標楷體;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體;">採集檢體供研究使用，除依法令規定外，依本注意事項為之。 </span></p><p><span style="font-family: 標楷體;">二、本注意事項用詞定義如下： </span></p><p><span style="font-family: 標楷體;">（一）檢體：指與人體分離之細胞、組織、器官、體液或其衍生物質（含 </span></p><p><span style="font-family: 標楷體;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體;">遺傳物質），包括剩餘檢體、採集自胎兒或屍體之檢體。 </span></p><p><span style="font-family: 標楷體;">（二）檢體提供者：指接受檢體採集之人。 </span></p><p><span style="font-family: 標楷體;">（三）檢體使用者：指直接使用檢體、指示他人使用檢體或依與檢體提供 </span></p><p><span style="font-family: 標楷體;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體;">者間之契約等特定關係而得使用檢體之人或機構。 </span></p><p><span style="font-family: 標楷體;">（四）檢體保管者：指保存檢體之人或機構。 </span></p><p><span style="font-family: 標楷體;">（五）編碼：以數字或英文字母等代碼，取代檢體提供者姓名、身份證字 </span></p><p><span style="font-family: 標楷體;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體;">號、病歷號等可供辨識個人資訊之作業方式。 </span></p><p><span style="font-family: 標楷體;">（六）去連結：於檢體編碼後，將代碼與檢體提供者可供辨識個人資訊之 </span></p><p><span style="font-family: 標楷體;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體;">對照資料完全永久消除之作業方式。 </span></p><p><span style="font-family: 標楷體;">（七）剩餘檢體：係指病理檢驗、醫事檢驗或研究剩餘之檢體。 </span></p><p><span style="font-family: 標楷體;">三、採集與使用檢體應先提具研究計畫書，並經人體試驗委員會或其他類 </span></p><p><span style="font-family: 標楷體;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體;">似之倫理委員會（以下簡稱倫理委員會）審核同意，始得為之。 </span></p><p><span style="font-family: 標楷體;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體;">以剩餘檢體進行研究，應於使用前提具研究計畫送倫理委員會審核。 </span></p><p><span style="font-family: 標楷體;">四、檢體之採集與使用不得違背醫學倫理，並應注意防制對人類、特定族 </span></p><p><span style="font-family: 標楷體;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體;">群及生態環境之危害。 </span></p><p><span style="font-family: 標楷體;">五、採集檢體供研究使用，除法律有規定者外，應告知檢體提供者下列事 </span></p><p><span style="font-family: 標楷體;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體;">項，並取得其同意： </span></p><p><span style="font-family: 標楷體;">（一）檢體採集之目的及其可能使用範圍與使用期間。 </span></p><p><span style="font-family: 標楷體;">（二）檢體採集之方法、種類、數量及採集部位。 </span></p><p><span style="font-family: 標楷體;">（三）檢體採集可能發生之併發症與危險。 </span></p><p><span style="font-family: 標楷體;">（四）檢體提供者之權益與檢體使用者、保管者之義務。 </span></p><p><span style="font-family: 標楷體;">（五）研究之重要性。 </span></p><p><span style="font-family: 標楷體;">（六）被選為參與者的原因。 </span></p><p><span style="font-family: 標楷體;">（七）預期之研究成果。 </span></p><p><span style="font-family: 標楷體;">（八）合理範圍內可預見之風險或不便。 </span></p><p><span style="font-family: 標楷體;">（九）保障檢體提供者個人隱私的機制。 </span></p><p><span style="font-family: 標楷體;">（十）檢體提供者得拒絕參與研究，並得隨時退出研究，及其退出之程序 </span></p><p><span style="font-family: 標楷體;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體;">。檢體提供者之拒絕或退出，不影響其應有之醫療照顧。 </span></p><p><span style="font-family: 標楷體;">（十一）研究檢體所得資訊對檢體提供者及其親屬或族群可能造成的影響 </span></p><p><span style="font-family: 標楷體;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體;">。 </span></p><p><span style="font-family: 標楷體;">（十二）檢體保管者與檢體使用者。 </span></p><p><span style="font-family: 標楷體;">（十三）檢體是否有提供、讓與或授權國內或國外之他人使用檢體之情形 </span></p><p><span style="font-family: 標楷體;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體;">。 </span></p><p><span style="font-family: 標楷體;">（十四）剩餘檢體之處理情形。 </span></p><p><span style="font-family: 標楷體;">（十五）研究經費來源及所有參與研究之機構。 </span></p><p><span style="font-family: 標楷體;">（十六）其他依各研究計畫之需要，與檢體採集、病歷檢閱、追蹤檢查檢 </span></p><p><span style="font-family: 標楷體;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體;">驗或病情資訊相關之重要事項。 </span></p><p><span style="font-family: 標楷體;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體;">以剩餘檢體供研究使用，除前項第二款及第三款外，其餘告知事項仍 </span></p><p><span style="font-family: 標楷體;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體;">應告知檢體提供者，取得同意。 </span></p><p><span style="font-family: 標楷體;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體;">前二項告知與同意應以書面為之，並輔以口頭告知，務使檢體提供者 </span></p><p><span style="font-family: 標楷體;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體;">明瞭其內容。 </span></p><p><span style="font-family: 標楷體;">六、採集胎兒之檢體，需經其母親同意。 </span></p><p><span style="font-family: 標楷體;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體;">檢體提供者為未滿七歲之未成年人，由其法定代理人代為同意；滿七 </span></p><p><span style="font-family: 標楷體;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體;">歲以上之未成年人，應由法定代理人與檢體提供者共同同意；檢體提 </span></p><p><span style="font-family: 標楷體;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體;">供者為無意思能力者，由法定代理人代為同意，無法定代理人時，由 </span></p><p><span style="font-family: 標楷體;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體;">最近親屬代為同意；屍體檢體之提供應得其最近親屬或本人生前之書 </span></p><p><span style="font-family: 標楷體;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體;">面同意。 </span></p><p><span style="font-family: 標楷體;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體;">前項最近親屬範圍如下： </span></p><p><span style="font-family: 標楷體;">（一）配偶。 </span></p><p><span style="font-family: 標楷體;">（二）成年之直系血親卑親屬。 </span></p><p><span style="font-family: 標楷體;">（三）父母。 </span></p><p><span style="font-family: 標楷體;">（四）兄弟姊妹。 </span></p><p><span style="font-family: 標楷體;">（五）祖父母。 </span></p><p><span style="font-family: 標楷體;">（六）曾祖父母或三親等旁系血親。 </span></p><p><span style="font-family: 標楷體;">（七）一親等直系姻親。 </span></p><p><span style="font-family: 標楷體;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體;">最近親屬書面同意得以一人行之；最近親屬意見不一致時，依前項各 </span></p><p><span style="font-family: 標楷體;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體;">款先後定其順序。 </span></p><p><span style="font-family: 標楷體;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體;">前項同一順序之人，以親等近者為先，親等同者，以同居親屬為先， </span></p><p><span style="font-family: 標楷體;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體;">無同居親屬者，以年長者為先。 </span></p><p><span style="font-family: 標楷體;">七、採集與使用檢體可能衍生其他如商業利益等權益時，檢體使用者應告 </span></p><p><span style="font-family: 標楷體;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體;">知檢體提供者並為必要之書面約定。 </span></p><p><span style="font-family: 標楷體;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體;">前項檢體採集自胎兒、屍體、未成年人或無意思能力者時，檢體使用 </span></p><p><span style="font-family: 標楷體;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體;">者應告知前點規定得為同意之人，並為必要之書面約定。 </span></p><p><span style="font-family: 標楷體;">八、當研究成果可合理預期對可辨識之檢體提供者個人健康有重大影響時 </span></p><p><span style="font-family: 標楷體;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體;">，檢體使用者經倫理委員會審核，且檢體提供者選擇知悉時，檢體使 </span></p><p><span style="font-family: 標楷體;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體;">用者應告知並協助提供必要之相關諮詢。 </span></p><p><span style="font-family: 標楷體;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體;">前項之倫理委員會審查，應考量檢體提供者健康危害的程度，與預防 </span></p><p><span style="font-family: 標楷體;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體;">及治療成本效益等因素。 </span></p><p><span style="font-family: 標楷體;">九、檢體使用者應在檢體提供者所同意或依法得使用之範圍內使用檢體。 </span></p><p><span style="font-family: 標楷體;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體;">使用檢體如逾越前項範圍，應依第三點、第五點及第七點規定辦理審 </span></p><p><span style="font-family: 標楷體;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體;">查及告知程序。 </span></p><p><span style="font-family: 標楷體;">十、除法律有規定者外，檢體提供者得拒絕接受採集、終止檢體使用之同 </span></p><p><span style="font-family: 標楷體;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體;">意或變更所同意之使用範圍。但檢體與個人資料已去連結者不在此限 </span></p><p><span style="font-family: 標楷體;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體;">。 </span></p><p><span style="font-family: 標楷體;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體;">檢體提供者拒絕檢體之採集或使用，應不影響其醫療或個人之權益。 </span></p><p><span style="font-family: 標楷體;">十一、檢體保管者或檢體使用者應妥善保存及管理檢體。 </span></p><p><span style="font-family: 標楷體;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體;">檢體使用完畢或檢體提供者終止檢體使用之同意時，應確實銷毀檢 </span></p><p><span style="font-family: 標楷體;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體;">體，非經檢體提供者事前之書面同意，不得繼續保存。但檢體已去 </span></p><p><span style="font-family: 標楷體;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體;">連結者不在此限。 </span></p><p><span style="font-family: 標楷體;">十二、檢體保管者與檢體使用者應尊重並保護檢體提供者之人格權。 </span></p><p><span style="font-family: 標楷體;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體;">對於因檢體採集、保存、使用所知悉之檢體提供者秘密、隱私或個 </span></p><p><span style="font-family: 標楷體;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體;">人資料，不得無故洩漏。 </span></p><p><span style="font-family: 標楷體;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體;">檢體保存及處理過程應以編碼、去連結或其他匿名方式為之。 </span></p><p><span style="font-family: 標楷體;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體;">檢體使用者將檢體所得資訊提供予第三人或公開其資料時，應以無 </span></p><p><span style="font-family: 標楷體;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體;">從識別檢體提供者個人資料之方式處理。 </span></p><p><span style="font-family: 標楷體;">十三、非經倫理委員會之審查，確保檢體提供者及我國民眾之權益及安全 </span></p><p><span style="font-family: 標楷體;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體;">，檢體不應讓與或授權國外使用。 </span></p><p><span style="font-family: 標楷體;">十四、具下列情形之一者，得不受第五點與第七點規定之限制，但應依第 </span></p><p><span style="font-family: 標楷體;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體;">三點規定經倫理委員會審查通過後，始得為之： </span></p><p><span style="font-family: 標楷體;">&nbsp; </span><span style="font-family: 標楷體;">（一）難以辨認檢體提供者身分。 </span></p><p><span style="font-family: 標楷體;">&nbsp; </span><span style="font-family: 標楷體;">（二）因無法追蹤或聯絡等原因，難以重新取得檢體提供者同意。 </span></p><p><span style="font-family: 標楷體;">&nbsp; </span><span style="font-family: 標楷體;">（三）本注意事項修正頒行前，已可公開取得之檢體。 </span></p><p><span style="font-family: 標楷體;">十五、依本注意事項採集之檢體使用於教學時，準用第十二點之規定。 </span></p> 2013-12-04
1420519 其他類,捐血者健康標準 法規命令 捐血者健康標準 <p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本標準依血液製劑條例第十四條第二項規定訂定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">捐血者須符合下列條件，始得捐血：</span> </p><p><span style="font-family: 新細明體,serif;">一、</span> <span style="font-family: 新細明體,serif;">年齡：</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">十七歲以上，六十五歲以下，一般健康情況良好。</span> </p><p><span style="font-family: calibri;">&nbsp; (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">未滿十七歲者，應視體能狀況，並經法定代理人之同意，始得捐血。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">逾六十五歲者，除應健康情況良好外，並應取得醫師之同意，始得捐血。</span> </p><p><span style="font-family: 新細明體,serif;">二、體重：</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">女性應四十五公斤以上，男性應五十公斤以上。</span> </p><p><span style="font-family: calibri;">&nbsp; (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">捐分離術血小板、分離術白血球及分離術血漿者，應五十公斤以上。</span> </p><p><span style="font-family: 新細明體,serif;">三、體溫：口溫不超過攝氏三七．五度。</span> </p><p><span style="font-family: 新細明體,serif;">四、血壓：收縮壓九○～一六○毫米汞柱，舒張壓五○～九五毫米汞柱，如兩者之距離低於三○或高於九○毫米汞柱，須經醫師許可。</span> </p><p><span style="font-family: 新細明體,serif;">五、血液檢查：</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">血紅素：男性十三公克％以上</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">使用硫酸銅法時血液比重一‧○五四</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">。女性十二公克％以上</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">使用硫酸銅法時血液比重一‧○五二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">血小板：捐血小板者，其血小板數目應在</span><span style="font-family: calibri;"> 15</span><span style="font-family: 新細明體,serif;">&times;</span><span style="font-family: calibri;">10,000</span><span style="font-family: 新細明體,serif;">／</span><span style="font-family: calibri;">mm3&nbsp; </span><span style="font-family: 新細明體,serif;">以上。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;(</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">白血球：捐白血球者，其絕對顆粒球數目應在</span><span style="font-family: calibri;"> 3,000</span><span style="font-family: 新細明體,serif;">／</span><span style="font-family: calibri;">mm3 </span><span style="font-family: 新細明體,serif;">以上。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 新細明體,serif;">四</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">血漿總蛋白：捐血漿者，應於首次捐血暨每隔半年加驗血漿總蛋白量，其血漿總蛋白應在</span><span style="font-family: calibri;"> 6g/d1&nbsp; </span><span style="font-family: 新細明體,serif;">以上。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 3 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">捐血者每次之捐血量及捐血間隔如下：</span> </p><p><span style="font-family: 新細明體,serif;">一、每次捐血以二五○毫升為原則，但體重六○公斤以上者，每次捐血得為五○○毫升。</span> </p><p><span style="font-family: 新細明體,serif;">二、每次捐血二五○毫升者，其捐血間隔應為二個月以上；每次捐血五○○毫升者，其捐血間隔應為三個月以上。但男性年捐血量應在一、五○○毫升以內；女性年捐血量應在一、○○○毫升以內。</span> </p><p><span style="font-family: 新細明體,serif;">三、捐分離術血小板、分離術白血球或分離術血漿者，每次之間隔為二星期以上。</span> </p><p><span style="font-family: 新細明體,serif;">四、捐分離術血漿量每次以五○○毫升為限，其全年捐血漿量不得超過十二公升。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 4 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">捐血者有下列情形之一者，應暫緩捐血：</span> </p><p><span style="font-family: 新細明體,serif;">一、婦女懷孕中或產後</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">含流產後</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">六個月以內者。</span> </p><p><span style="font-family: 新細明體,serif;">二、大手術未滿一年或一年內曾接受輸血者。</span> </p><p><span style="font-family: 新細明體,serif;">三、四星期內曾接種麻疹、德國麻疹、腮腺炎及小兒麻痺</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">口服</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">等活性減毒疫苗者。</span> </p><p><span style="font-family: 新細明體,serif;">四、六個月內曾罹患肝炎或密切接觸肝炎病患者。</span> </p><p><span style="font-family: 新細明體,serif;">五、現患梅毒、活動性結核病、糖尿病、心臟病、消化道潰瘍出血、高血壓、腎臟病、哮喘、感冒、急性感染、傳染病、過敏病症者。</span> </p><p><span style="font-family: 新細明體,serif;">六、自瘧疾疫區回國一年內或曾在三年內罹患瘧疾者。</span> </p><p><span style="font-family: 新細明體,serif;">七、曾在七十二小時內拔牙者。</span> </p><p><span style="font-family: 新細明體,serif;">八、曾在五天內服用含</span><span style="font-family: calibri;"> Aspirin</span><span style="font-family: 新細明體,serif;">、類藥物或其他可抑制血小板功能之藥物者，不得捐血小板。</span> </p><p><span style="font-family: 新細明體,serif;">九、</span><span style="font-family: calibri;">B </span><span style="font-family: 新細明體,serif;">型肝炎表面抗原檢查呈陽性反應者。</span> </p><p><span style="font-family: 新細明體,serif;">十、</span><span style="font-family: calibri;">C </span><span style="font-family: 新細明體,serif;">型肝炎病毒抗體檢查呈陽性反應者。</span> </p><p><span style="font-family: 新細明體,serif;">十一、民國六十九年至八十五年間曾在英國輸血或曾至英國旅遊或居留時間合計超過三個月者，或民國六十九年以後曾於歐洲旅遊或居留時間合計超過五年者。</span> </p><p><span style="font-family: 新細明體,serif;">十二、經通報為嚴重急性呼吸道症候群疑似或可能病例，於治療痊癒後，未逾三個月內者。</span> </p><p><span style="font-family: 新細明體,serif;">十三、曾與嚴重急性呼吸道症候群疑似或可能病例密切接觸，於最後接觸日起一個月內者。</span> </p><p><span style="font-family: 新細明體,serif;">十四、自有地區性傳播嚴重急性呼吸道症候群之地區回國後一個月內者。</span> </p><p><span style="font-family: 新細明體,serif;">十五、自西尼羅病毒流行區離境日起一個月內者。</span> </p><p><span style="font-family: 新細明體,serif;">十六、懷疑自己感染愛滋病毒者或二年內曾與可能感染愛滋病毒者發生性行為者。</span> </p><p><span style="font-family: 新細明體,serif;">十七、一年內曾從事危險性行為或曾罹患性病</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">梅毒、淋病、披衣菌、生殖器皰疹、軟性下疳、尖型濕疣等</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">者。</span> </p><p><span style="font-family: 新細明體,serif;">十八、一年內曾刺青者。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 5 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">捐血者有下列情形之一者，永不得捐血：</span> </p><p><span style="font-family: 新細明體,serif;">一、曾患惡性腫瘤、白血病或其他經醫師認為永久不得捐血者。</span> </p><p><span style="font-family: 新細明體,serif;">二、曾有出血不止、抽痙或昏迷之病史者。</span> </p><p><span style="font-family: 新細明體,serif;">三、曾有吸毒或慢性酒精中毒者。</span> </p><p><span style="font-family: 新細明體,serif;">四、靜脈注射藥物成癮者、男性間性行為者及長期使用血液製劑者。</span> </p><p><span style="font-family: 新細明體,serif;">五、曾為</span><span style="font-family: calibri;"> AIDS </span><span style="font-family: 新細明體,serif;">患者。</span> </p><p><span style="font-family: 新細明體,serif;">六、愛滋病毒第一型及第二型</span><span style="font-family: calibri;"> (HIV-I</span><span style="font-family: 新細明體,serif;">／</span><span style="font-family: calibri;">HIV-II)</span><span style="font-family: 新細明體,serif;">、抗體檢查經確認呈陽性反應者。</span> </p><p><span style="font-family: 新細明體,serif;">七、人類嗜</span><span style="font-family: calibri;"> T</span><span style="font-family: 新細明體,serif;">、淋巴球病毒第一型</span><span style="font-family: calibri;"> (HTLV-I) </span><span style="font-family: 新細明體,serif;">抗體檢查經確認呈陽性反應者。</span> </p><p><span style="font-family: 新細明體,serif;">八、曾罹患庫賈氏病者</span><span style="font-family: calibri;"> (CJD)</span><span style="font-family: 新細明體,serif;">、曾注射人類腦下垂體生長荷爾蒙者、曾注射人類腦下垂體親生殖腺素</span><span style="font-family: calibri;"> (human pituitary gonadotropins)&nbsp; </span><span style="font-family: 新細明體,serif;">者、曾注射牛胰島素等生物製劑者、曾接受硬腦膜移植者或家族中有庫賈氏病</span><span style="font-family: calibri;"> (CJD)&nbsp; </span><span style="font-family: 新細明體,serif;">患者。</span> </p><p><span style="font-family: 新細明體,serif;">九、曾從事性工作者。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 6 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">捐血機構對捐血者實施健康篩檢之項目如附表。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 7 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本標準自發布日施行。</span> </p> 2013-12-04 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6067&type=0
1420520 查驗登記類,核醫放射性藥品審查基準 行政解釋 核醫放射性藥品審查基準 <pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">第一章</span><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">通論</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">為確保上市核醫放射性藥品的品質、安全性及有效性，並使查驗登記檢送</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">資料時有所依據，特訂定「核醫放射性藥品審查基準」。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">一</span><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">本基準所稱「核醫放射性藥品」係指符合藥事法第六條之藥品定義，</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">以具有放射活度之物質使用於人體內，經體內分佈之後，可被用來診</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">斷、監測、治療或緩解疾病等具醫療效能之藥品或生物製劑。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">二</span><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">核醫放射性藥品應符合藥事法及相關規範之管理，如：優良藥品製造</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">規範、藥品優良臨床試驗規範、藥品非臨床試驗優良操作規範、藥品</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">非臨床試驗安全性規範等。有關放射性物質之輸出入、運送、處理及</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">貯存，應符合國內相關主管機關管理法規。含有放射性物質的生物製</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">劑，則並應符合生物製劑相關法規的要求。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">三</span><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">核醫放射性藥品於查驗登記所檢附的各項資料，應由合乎相關基準的</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">試驗獲得，或參考已發表的文獻，及由模式推估及數據分析等其他方</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">式而獲得。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">四</span><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">一般診斷用核醫放射性藥品之安全性評估，可考慮其不同於一般化學</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">醫藥品之毒性試驗，但對該藥品輻射劑量</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (radiation dosimetry)</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">仍應作適當評估。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">五</span><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">核醫放射性藥品品質與安定性的評估要項，包括：藥品類屬、藥品技</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">術檔案及藥品安定性試驗報告，另須檢附國外採用證明或處方依據等</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">相關資料。</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">參考本基準第二章</span><span style="font-family: times new roman,serif; font-size: 11pt;">)</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">六</span><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">診斷用核醫放射性藥品的非臨床毒理安全性試驗，應依所宣稱的藥品</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">安全性分級來進行。</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">參考本基準第三章</span><span style="font-family: times new roman,serif; font-size: 11pt;">)</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">七</span><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">核醫放射性藥品的臨床安全性與有效性，雖然並不完全是針對某一種</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">或某一類特定的疾病，但是仍應針對所宣稱適應症，提供正確及有效</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">之臨床試驗資料。</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">參考本基準第四章</span><span style="font-family: times new roman,serif; font-size: 11pt;">)</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">八</span><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">申請查驗登記應檢送之文件資料請參考附表，並依資料分類裝訂成冊</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">第二章</span><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">核醫放射性藥品之品質與安定性</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">核醫放射性藥品之品質與安定性資料包括：藥品類屬、藥品技術檔案、藥</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">品安定性試驗報告、國外採用證明等。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">一</span><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">藥品類屬：</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 標楷體; font-size: 11pt;">一</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">醫用放射性同位素發生器：係指放射性同位素母核種與子核種經一</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">定分離步驟後，方可提供放射性子核種進行核醫放射性藥品之調劑</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</span><span style="font-family: 標楷體; font-size: 11pt;">或標識，如：</span><span style="font-family: times new roman,serif; font-size: 11pt;">99mTc </span><span style="font-family: 標楷體; font-size: 11pt;">放射性同位素發生器。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 標楷體; font-size: 11pt;">二</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">標識前驅劑：係指製備後，即可提供放射性核種進行核醫放射性藥</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">品之調劑或標識，如：</span><span style="font-family: times new roman,serif; font-size: 11pt;">111InCl3&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">標識前驅劑。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 標楷體; font-size: 11pt;">三</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">放射性即用製劑：係指已製備好可立即使用之核醫放射性藥品，如</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">：</span><span style="font-family: times new roman,serif; font-size: 11pt;">201TlCl </span><span style="font-family: 標楷體; font-size: 11pt;">心臟造影劑。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 標楷體; font-size: 11pt;">四</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">非放射性即用套組：係指該成品經放射性同位素之標識及時調劑後</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</span><span style="font-family: 標楷體; font-size: 11pt;">，方為核醫放射性藥品，如：</span><span style="font-family: times new roman,serif; font-size: 11pt;">MDP </span><span style="font-family: 標楷體; font-size: 11pt;">骨骼造影劑。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 標楷體; font-size: 11pt;">五</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">其他類核醫放射性藥品。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">二</span><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">藥品技術檔案：</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 標楷體; font-size: 11pt;">一</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">起源、發現之經過或國外使用情形：係指核醫放射性藥品的研究背</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">景、參考文獻、使用情形及與其他藥品之比較等。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 標楷體; font-size: 11pt;">二</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">物理及化學性質、檢驗方法及規格：係指該醫放射性藥品所使用成</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">份之物理化學的性狀、檢驗規格方法及檢驗成績書</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">包括原料及成</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</span><span style="font-family: 標楷體; font-size: 11pt;">品</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">等資料。同時應對所使用的放射性同位素，註明核種名稱、核</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">種純度、核種能譜、比放射活度等；並對所使用的放射性同位素標</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">識化合物，註明供應者、合成方法、標識方法、純度、標識位置及</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">經時安定性等。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 標楷體; font-size: 11pt;">三</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">與所附成品檢驗成績書同批號之完整批次紀錄，或製造管制標準書</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 標楷體; font-size: 11pt;">四</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">申請無菌製劑查驗登記，應檢附無菌製劑滅菌及無菌充填確效之書</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">面作業程序及報告資料。</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">依本署</span><span style="font-family: times new roman,serif; font-size: 11pt;"> 84.4.29&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">衛署藥字第</span><span style="font-family: times new roman,serif; font-size: 11pt;"> 8402349</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 0 </span><span style="font-family: 標楷體; font-size: 11pt;">號公告</span><span style="font-family: times new roman,serif; font-size: 11pt;">)</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">三</span><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">藥品安定性試驗書面作業程序及其檢驗報告：</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">參考本署</span><span style="font-family: times new roman,serif; font-size: 11pt;"> 75.6.13</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">衛署藥字第</span><span style="font-family: times new roman,serif; font-size: 11pt;"> 597181 </span><span style="font-family: 標楷體; font-size: 11pt;">號公告，或</span><span style="font-family: times new roman,serif; font-size: 11pt;"> 87.7.22&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">衛署藥字第</span><span style="font-family: times new roman,serif; font-size: 11pt;"> 87041838 </span><span style="font-family: 標楷體; font-size: 11pt;">公</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">告</span><span style="font-family: times new roman,serif; font-size: 11pt;">)</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 標楷體; font-size: 11pt;">一</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">核醫放射性藥品之藥品安定性試驗報告，一般須包括該藥品之三批</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">次經時安定性及有效期限的評估數據。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 標楷體; font-size: 11pt;">二</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">若為短半衰期核種</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">如：正子放射製劑</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">的核醫放射性藥品，其安</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">定性試驗報告，應以具科學意義並能合理顯示藥品品質為均勻穩定</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">之評估試驗取代。亦可依據該藥品製備系統的線上管制紀錄</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (on</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; line control records) </span><span style="font-family: 標楷體; font-size: 11pt;">加以分析確認。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">四</span><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">國外採用證明：</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</span><span style="font-family: 標楷體; font-size: 11pt;">輸入核醫放射性藥品應依本署</span><span style="font-family: times new roman,serif; font-size: 11pt;"> 87.3.13&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">衛署藥字第</span><span style="font-family: times new roman,serif; font-size: 11pt;"> 87010820 </span><span style="font-family: 標楷體; font-size: 11pt;">號公</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">告規定，檢附國外採用證明。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">第三章</span><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">診斷用核醫放射性藥品之毒理與安全性</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">核醫放射性藥品之毒理及安全性資料，應能作為決定使用劑量及安全性分</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">級之參考。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">一</span><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">診斷用核醫放射性藥品依其組成成分及使用劑量的安全性分為三級：</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 標楷體; font-size: 11pt;">一</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">第一級核醫放射性藥品：</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 1 </span><span style="font-family: 標楷體; font-size: 11pt;">該核醫放射性藥品的組成成分為一般化學物質，且其放射活度僅</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">限於示蹤劑量，不足以引起任何明顯的藥理反應。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 2 </span><span style="font-family: 標楷體; font-size: 11pt;">該類藥品的劑量範圍試驗</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (dosing ranging study) </span><span style="font-family: 標楷體; font-size: 11pt;">，一般可以</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">免除；其輻射劑量範圍下限可由數學或物理的模式推估，上限則</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">以生物體可接受之輻射劑量為依據。通常不須註明最大耐受劑量</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 標楷體; font-size: 11pt;">二</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">第二級核醫放射性藥品：</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 1 </span><span style="font-family: 標楷體; font-size: 11pt;">該核醫放射性藥品之放射活度僅限於示蹤劑量，但因其組成成分</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">含有生物物質，仍有可能引起過敏或其他免疫反應，故應進行免</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">疫學反應的研究與評估。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 2 </span><span style="font-family: 標楷體; font-size: 11pt;">該類藥品因為可能具抗原反應，所以應以具最高放射活度劑量</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; the highest radioactive dose) </span><span style="font-family: 標楷體; font-size: 11pt;">之最低蛋白質劑量</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (the low-</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;est protein dose) </span><span style="font-family: 標楷體; font-size: 11pt;">，為適當使用劑量，通常也不須註明最大耐</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">受劑量。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 標楷體; font-size: 11pt;">三</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">第三級核醫放射性藥品：</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 1 </span><span style="font-family: 標楷體; font-size: 11pt;">當核醫放射性藥品之使用劑量足以產生藥理反應時，應針對該藥</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">品之特殊活性所可能產生之危險進行安全性評估。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 2 </span><span style="font-family: 標楷體; font-size: 11pt;">該類藥品以可表現出臨床可觀察之藥理反應的劑量為最高劑量，</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">而以能產生令人滿意影效果的劑量為最低劑量。在第一階段臨床</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">試驗中，須以一定數目的病人進行廣泛的安全性評估。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">二</span><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">劑量決定的原則：</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 標楷體; font-size: 11pt;">一</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">通常診斷用核醫放射性藥品的劑量，應該以病人所接受的放射活度</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">與輻射劑量來估計，而不是由藥品所產生的藥理或不良反應的劑量</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">來決定。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 標楷體; font-size: 11pt;">二</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">要估計診斷用核醫放射性藥品的劑量，應根據至少一種動物及一定</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</span><span style="font-family: 標楷體; font-size: 11pt;">數量的人體試驗所蒐集到的生體分佈性資料來推估。職業上容許的</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">最大暴露劑量，並不適宜用來建立診斷用核醫放射性藥品的輻射劑</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">量的指標。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">三</span><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">毒性試驗：診斷用核醫放射性藥品的非臨床安全性評估，一般不須進</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">行重覆劑量毒性試驗</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">如：慢性毒性試驗</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">、生殖毒性試驗及致癌性</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">毒性試驗</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">或致基因變異性試驗</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">。對於第三級的診斷用放射性藥品</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;</span><span style="font-family: 標楷體; font-size: 11pt;">，可能仍需進行單一劑量毒性試驗</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">急性毒性試驗</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">第四章</span><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">核醫放射性藥品之臨床安全性與有效性</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">核醫放射性藥品的臨床安全性與有效性，雖然並不完全是針對某一種或某</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">一類特定的疾病，但是仍應針對所宣稱適應症，提供正確及有效之臨床試</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">驗資料，以評估該藥品的臨床安全與有效性。其檢附之資料應包括：適應</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">症類屬、臨床資料或推估模式</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (model approach) </span><span style="font-family: 標楷體; font-size: 11pt;">、不良反應等。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">一</span><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">適應症類屬：</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 標楷體; font-size: 11pt;">一</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">作為器官或組織定位之評估：主要在提供器官或組織定位及標示之</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">評估，同時對其外觀正常與否亦可提供評估資料，如：定位腸道或</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">血管所在等。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 標楷體; font-size: 11pt;">二</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">作為器官、身體系統功能或生化特性之評估：申請者應提供正常人</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">的生理值及可接受的信賴區間，以作為該藥品用於診斷或治療時，</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">可供判斷的定性或定量上參考數據。如：心臟射出分率、心肌壁活</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">動情況、大腦血流灌注、葡萄糖代謝與特定受體功能評估等。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 標楷體; font-size: 11pt;">三</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">作為疾病或特定器官專一性之評估：主要在以藥品的敏感度、專一</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">性對疾病或特定器官進行偵測評估，如：單株抗體偵測特定腫瘤或</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">以標識細胞</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (labeled cell) </span><span style="font-family: 標楷體; font-size: 11pt;">方式偵測感染或栓塞與否等。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 標楷體; font-size: 11pt;">四</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">作為決定醫療處置及其結果影響之評估：主要在提供資訊以決定對</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">病患之醫療處置，如：冠狀動脈疾病術後評估、疾病復發後可否進</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">行再切除手術、組織存活力、病人預後及介入性治療成效</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (inter-</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; ventional outcome)&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">之評估等。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">二</span><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">臨床資料或推估模式：</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">除了傳統上對以特定疾病作為適應症的臨床試驗方法以外，對於不是</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">針對特定疾病的核醫放射性藥品，得以下列臨床研究的模式推估</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (m-</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; odel approach)&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">進行評估：</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 標楷體; font-size: 11pt;">一</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">疾病發展過程的推估模式：這類臨床試驗主要是針對某些具有共通</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">病程之非特定疾病來進行評估，以決定該類藥品之適應症。例如：</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">器官壁運動的改變或解剖學之異常等。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 標楷體; font-size: 11pt;">二</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">多重小規模分組的推估模式：這類臨床試驗設計可先將參與臨床試</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">驗的病人加以分組，例如：依疾病來分組，但對每一分組的受試病</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">患數目仍須事先考量，以符合統計學的需求。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">三</span><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">不良反應：</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 標楷體; font-size: 11pt;">一</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">核醫放射性藥品的不良反應，可能是由於病人潛在的疾病、焦慮等</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">心理因素或是放射性造影過程本身所引起。此時可於各種藥品的回</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">溯性病歷資料中，對於某種特定模式的用藥程序</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (modality) </span><span style="font-family: 標楷體; font-size: 11pt;">，蒐</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">集不良反應的型式和發生頻率等記錄，此有助於了解該項藥品的不</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">良反應。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 標楷體; font-size: 11pt;">二</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">診斷用核醫放射性藥品的不良反應有可能是品本身所引起，此時也</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">可使用安慰劑</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">如：不帶放射性活度的該品</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">來進行安全性評估。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">安慰劑所產生的不良反應也可用來建立該放射性藥品的安全性資料</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">，並應加註於該產品的標籤、仿單之上。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">四</span><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">當沒有任何已上市的核醫放射性藥品可與該藥比較時，可以針對其所</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">宣稱的適應症，以另一種已建立安全性及有效性的診斷方式或臨床資</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;</span><span style="font-family: 標楷體; font-size: 11pt;">料來評估，如：外科手術之觀察或組織病理學資料。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">第五章</span><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">治療用核醫放射性藥品之特殊考量</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">大部份於第二章、第三章及第四章列舉之基準要項，皆適用於治療用核醫</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">放射性藥品。下列各點係針對治療用核醫放射性藥品查驗登記時，所需注</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">意之特殊考量</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">參考本署</span><span style="font-family: times new roman,serif; font-size: 11pt;"> 88.5.14&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">衛署藥字第</span><span style="font-family: times new roman,serif; font-size: 11pt;"> 88027704 </span><span style="font-family: 標楷體; font-size: 11pt;">號公告</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">一</span><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">非臨床資料：</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 標楷體; font-size: 11pt;">一</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">輻射劑量之動物體內分佈試驗、本試驗乃為治療用核醫放射性藥品</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">初步計算輻射劑量之基礎。因為對同一核醫放射性藥品而言，診斷</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">劑量與治療劑量所造成之生物體分佈可能不同，故輻射劑量之動物</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">體內分佈試驗，應在不同之輻射劑量之進行。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 標楷體; font-size: 11pt;">二</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">動物毒性試驗：由於治療所需藥品之輻射劑量，一般比診斷所需劑</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">量高，所以對治療用核醫放射性藥品，應以較廣泛之動物毒性試驗</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">進行評估</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">請參照「藥品非臨床試驗安全性規範」第五章</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">。在某</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">些狀況中，可能需要進行重覆劑量毒性試驗。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 標楷體; font-size: 11pt;">三</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">輻射生物毒性試驗</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (radiobiologic toxicity study) </span><span style="font-family: 標楷體; font-size: 11pt;">：輻射生物</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">毒性之評估，應用兩種不同種類動物</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">請參照「藥品非臨床試驗安</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">全性規範」第五章</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">，使用足供療效之輻射劑量範圍之治療用核醫</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">放射性藥品之後，以決定該藥品之輻射效應</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (radiobiology effe-</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; ct) </span><span style="font-family: 標楷體; font-size: 11pt;">。對於治療用核醫放射性藥品，須進行長期追縱試驗，方可適</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">當評估輻射效應。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 標楷體; font-size: 11pt;">四</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">若有適當動物模式可以進行試驗，則應於治療用核醫放射性藥品進</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">行臨床試驗前，以該動物模式確認藥品可能療效。請參照「藥品非</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">臨床試驗安全性規範」。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">二</span><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">臨床資料：</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 標楷體; font-size: 11pt;">一</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">治療用核醫放射性藥品之臨床資料，應針對該藥品所稱之適應症提</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">供臨床效益評估，並說明可能產生的風險及適當之臨床處置等。臨</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">床評估的項目包括：藥品之血液清除率、排泄、器官分佈等數據。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">另骨髓分佈之評估亦特別重要，因其輻射劑量最主要之限制為對骨</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">髓之毒性。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 標楷體; font-size: 11pt;">二</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">治療用核醫放射性藥品之臨床使用劑量，應以輻射劑量學計算，以</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">能產生療效之最低輻射劑量為起始劑量，並以不會產生病人無法接</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">受毒性作用</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (disabling toxicity) </span><span style="font-family: 標楷體; font-size: 11pt;">之輻射劑量為最高劑量。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 標楷體; font-size: 11pt;">三</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">治療用核醫放射性藥品之不良反應：治療用核醫放射性藥品應視需</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">要長期追蹤使用患者之後期不良反應及其治療效果。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">參考文獻</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 1 </span><span style="font-family: 標楷體; font-size: 11pt;">行政院衛生署</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (1990).&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">「優良藥品製造標準」</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">台北</span><span style="font-family: times new roman,serif; font-size: 11pt;">)</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 2 </span><span style="font-family: 標楷體; font-size: 11pt;">行政院衛生署</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (1994).&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">「藥事法及其施行細則」</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">台北</span><span style="font-family: times new roman,serif; font-size: 11pt;">)</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;3 </span><span style="font-family: 標楷體; font-size: 11pt;">行政院衛生署</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (1996).&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">「藥品優良臨床試驗規範」</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">台北</span><span style="font-family: times new roman,serif; font-size: 11pt;">)</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 4 </span><span style="font-family: 標楷體; font-size: 11pt;">行政院衛生署</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (1997).&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">「藥品臨床試驗申請須知」</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">台北</span><span style="font-family: times new roman,serif; font-size: 11pt;">)</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 5 </span><span style="font-family: 標楷體; font-size: 11pt;">行政院衛生署</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (1998).&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">「藥品非臨床試驗優良操作規範」</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">台北</span><span style="font-family: times new roman,serif; font-size: 11pt;">)</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 6 </span><span style="font-family: 標楷體; font-size: 11pt;">行政院衛生署</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (1998).&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">「藥品非臨床試驗安全性規範」</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">台北</span><span style="font-family: times new roman,serif; font-size: 11pt;">)</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 7 </span><span style="font-family: 標楷體; font-size: 11pt;">行政院衛生署</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (1998).&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">「藥品生體可用率及生體相等性試驗基準及相</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">關資料」</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">台北</span><span style="font-family: times new roman,serif; font-size: 11pt;">)</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8 </span><span style="font-family: 標楷體; font-size: 11pt;">行政院衛生署</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (1998).&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">「藥品安定性試驗基準」</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">台北</span><span style="font-family: times new roman,serif; font-size: 11pt;">)</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 9 </span><span style="font-family: 標楷體; font-size: 11pt;">行政院衛生署</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (1999).&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">「藥品優良製造確效作業基準」</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">台北</span><span style="font-family: times new roman,serif; font-size: 11pt;">)</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 10 </span><span style="font-family: 標楷體; font-size: 11pt;">行政院衛生署</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (1999).&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">「輸入藥品查驗登記審查準則」</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">台北</span><span style="font-family: times new roman,serif; font-size: 11pt;">)</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 11 </span><span style="font-family: 標楷體; font-size: 11pt;">行政院衛生署</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (1999).&nbsp; </span><span style="font-family: 標楷體; font-size: 11pt;">「核醫放射性藥品臨床試驗基準」</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">台北</span><span style="font-family: times new roman,serif; font-size: 11pt;">)</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 12 Guidelines for the Clinical Evaluation of Radiopharmaceutical</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Drugs.&nbsp; CDER, FDA, USA; Oct.&nbsp; 1981</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 13 Proposal by Council on Radionuclides and Radiopharmaceuticals</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; for a Regulation Governing Evaluation and Approval of Diagnos-</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; tic Radiopharmaceuticals.&nbsp; FDA, USA; Jan.&nbsp; 1998</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 14 Extending the Scope of Directives 65/65/EEC and 75/319/EEC and</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Laying down Additional Provisions for Radiopharmaceuticals.</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Official Journal of the European Communities; May 1989</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 15 Japan Pharmaceutical Reference.&nbsp; Japan Medical Products Inter-</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; national Trade Association; 1996</span></pre> 2013-12-04
1420521 臨床試驗類,藥品臨床試驗基準,核醫放射性藥品臨床試驗基準 行政解釋 核醫放射性藥品臨床試驗基準 詳如附件 2013-12-04 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=230&type=0;;https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4515&type=0
1420522 化學製造管制類,國內藥品委託檢驗實施要點 行政解釋 國內藥品委託檢驗實施要點 <pre style="text-align: center;"><b><span style="font-family: 細明體;">國內藥品委託檢驗實施要點 </span></b></pre><pre style="text-align: center;"><span style="font-family: 細明體; font-size: 11pt;">&nbsp;</span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 11pt;">一&nbsp; 本藥品委託檢驗實施要點 (以下簡稱本要點) ，依藥品優良製造規範 </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 11pt;">第廿二點第五項規定訂定。 </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 11pt;">二&nbsp; 行政院衛生署 (以下簡稱本署) ，為促進生物科技製藥產業之整體發 </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 11pt;">展，並配合藥品優良製造規範之實施，及考量藥廠業務分工之需求， </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 11pt;">乃對藥品之委託檢驗予以規範。在不影響委託者、受託者及消費者間 </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 11pt;">之權益，並避免因不當之作業或檢驗而造成爭執，特訂定本要點。 </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 11pt;">三&nbsp; 藥品之委託檢驗應依本要點及其他相關法令之規定。 </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 11pt;">四&nbsp; 凡持有藥品許可證於有效期限內之藥商，或新申請藥品查驗登記之藥 </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 11pt;">商，均可依據本要點申請委託檢驗。 </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 11pt;">五&nbsp; 受託檢驗者須為國內符合藥品優良製造規範各階段之 cGMP 「現行藥 </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 11pt;">品優良製造規範 (current Good Manufacturing Practices，簡稱cG</span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; MP) </span><span style="font-size: 11pt;">」藥廠，或符合優良實驗室操作規範 (Good Laboratory Pract-</span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; ices</span><span style="font-size: 11pt;">，簡稱GLP)&nbsp; 精神之國內學術、研究及檢驗機構等相關單位，始 </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 11pt;">得接受委託檢驗。 </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 11pt;">特殊情況可專案申請。 </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 11pt;">六&nbsp; 委託檢驗者應訂定該委託檢驗範圍之相關事項，委託者及受託者應訂 </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 11pt;">定作業計畫書、標準作業程序 (含採樣方法、樣本保存方法、運送移 </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 11pt;">交條件等) ，俾便受託者依合約規定執行作業。 </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 11pt;">七&nbsp; 委託檢驗之範圍包括：技術層面之研究發展、製程中之管制作業及原 </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 11pt;">物料、半製品或產品之品質管制、安定性試驗等項目。 </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 11pt;">八&nbsp; 委託檢驗應由委託者先行覓妥受託檢驗單位，由委託者填具申請書， </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 11pt;">檢附雙方簽訂之委託檢驗作業計畫書、標準作業程序等相關文件，向 </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 11pt;">本署藥物食品檢驗局報備。藥物食品檢驗局未於二個月內回復者，應 </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 11pt;">視同核備。 </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;">&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</span><span style="font-size: 11pt;">藥物食品檢驗局得視實際需要對受託者進行現場查核。 </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 11pt;">九&nbsp; 受託檢驗單位之作業，應符合藥品優良製造規範中品質管制之規定， </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 11pt;">並對檢驗結果之準確性負責。其各相關紀錄應由委託者及受託檢驗者 </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 11pt;">依藥品優良製造規範第四十八點及第五十點規定予以保存。 </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 11pt;">一○&nbsp; 經核備之委託檢驗，委託者應檢附依檢驗所需二倍以上數量之檢體 </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 11pt;">，送受託者檢驗，其驗餘完整包裝之檢體，由受託者封緘後，交由 </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 11pt;">委託者自行保存。 </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 11pt;">一一&nbsp; 經核准委託檢驗之藥品，除法律另有規定外，其產品責任應由委託 </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 11pt;">者負責。 </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 11pt;">一二&nbsp; 委託檢驗於合約有效期限屆滿再續約時，或因故中途解約時，或另 </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 11pt;">覓妥其他受託者時，委託者應重新辦理報備。 </span></span></pre> 2013-12-04 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=881&type=0
1420523 查驗登記類,國產創新藥品查驗登記專案試辦計畫 行政解釋 國產創新藥品查驗登記專案試辦計畫 詳如附件 2013-12-04 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4516&type=0
1420524 化學製造管制類,指導手冊,國際醫藥品稽查協約組織藥品優良製造規範指導手冊 行政解釋 國際醫藥品稽查協約組織(PIC_S)_GMP-第一部及附則 詳如附件 2013-12-04 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4517&type=0
1420525 化學製造管制類,指導手冊,國際醫藥品稽查協約組織藥品優良製造規範指導手冊 行政解釋 國際醫藥品稽查協約組織(PIC_S)_GMP-第二部（原料藥） 詳如附件 2013-12-04 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4518&type=0
1420526 罕見疾病類,罕見疾病藥物,專案進口罕見疾病藥物年度使用評估報告表 行政解釋 專案進口罕見疾病藥物年度使用評估報告表 詳如附件 2013-12-04 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4519&type=0
1420527 化學製造管制類,指導手冊,現行藥品優良製造規範-清潔確效作業指導手冊 行政解釋 現行藥品優良製造規範-清潔確效作業指導手冊 <p><span style="font-family: 新細明體,serif;">現行藥品優良製造規範</span><span style="font-family: calibri;">-</span><span style="font-family: 新細明體,serif;">清潔確效作業指導手冊</span> </p><p><span style="font-family: 新細明體,serif;">壹、前言</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">本手冊主要參考加拿大</span><span style="font-family: calibri;">Cleaning validation guidelines-Therapeutic products programme</span><span style="font-family: 新細明體,serif;">，及美國</span><span style="font-family: calibri;">FDA Guide to inspections validation of cleaning processes </span><span style="font-family: 新細明體,serif;">兩份資料，並參酌國內相關資料所制訂。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">對於設備使用前必須是清潔的規定，是眾所皆知之事，其主要目的是避免藥品的污染與羼雜、不適當的清潔及設備維護，或塵埃控制系統不良而造成污染。尤其是非盤尼西林與盤尼西林藥品的交互污染，或藥品與類固醇、細胞毒劑或荷爾蒙的交互污染。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">例如，在美國</span><span style="font-family: calibri;">1988</span><span style="font-family: 新細明體,serif;">年</span><span style="font-family: calibri;">Cholestyramine Resin USP</span><span style="font-family: 新細明體,serif;">的容器重複使用，疑似因清潔及檢驗不確實，引起交叉污染而致產品回收。另外於</span><span style="font-family: calibri;">1992</span><span style="font-family: 新細明體,serif;">年，製造廠商所提出的清潔確效，只證明沒有上一製程的殘留化合物，但從洗滌水的薄層層析法中，發現有上一製程反應中的副產物和分解物。此二案例，為清潔不恰當的兩個案例，因此可見清潔確效之必要性。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">本手冊是對於清潔確效，有關的問題與主題提出一些指引，而並非法定要求。清潔確效應與其它確效一樣，不只一種方法，如果依照適當科學方法，提出建議並做成證明文件，亦可接受。使用此手冊時另請參閱藥品優良製造確效作業基準第二編第二章之相關規定。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">貳、範圍</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">本手冊是針對使用於製劑，及原料藥（含生物製劑之有效成分）之製造設備，訂出與清潔確效相關原則，與先前產品之污染物的移除，有關之清潔的確效、洗滌劑的殘留物，以及潛在微生物污染物的管制等。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">參、原則</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">一、清潔確效的目標，是要確認清潔程序對產品殘留物、分解產物、防腐劑、賦形劑及</span><span style="font-family: calibri;">/</span><span style="font-family: 新細明體,serif;">或清潔劑之移除的有效性，藉使例行階段中的分析監測，可以減至最少。此外，我們還需要確保不會與有效成分交互污染有關的危險性。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">二、清潔程序必須要嚴格遵循確效過的方法。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">三、對所有製程中與產品接觸的設備應研訂出適當的清潔步驟。對產品可能污染到的間接接觸的零件，如墊圈、混合機軸、烘箱之風扇，及加熱的元件等，亦應考量到其清潔之步驟。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">四、對於生物性藥物，由於它們固有的特徵（蛋白質本質上是黏性的）、注射劑的純度要求、設備的複雜性以及需待清除之廣泛物質，所以，相關的製程設備清潔確效方法，也要有所要求。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">五、對於非常相似的產品與製程，其清潔程序不需要去做個別的確效，可依其共通性、設備與表面積、或者是涉及所有與產品相接觸之設備的環境去做出決定。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">對於相似的產品和相似的製程的清潔步驟，可以選擇具代表性的方法，如依據產品的相似物理性、配方組成、消費者之使用的方式與使用量、先前製造之其它產品的特性，以及，與先前製造之產品相比較的批量等，都是證明一種確效計畫之關鍵因素。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">選擇最差情況的組合，及其相關基準來實施確效作業，一般認為是可以接受的。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">對於生物製劑，籃狀試驗法將只在假定其所涉及的是相同產品之少數情況，才可以被接受（例如，在同種類且以相近細胞培養液培養齧齒類細胞株中，以表現出重組蛋白質時，相同設計，但有不同容量之發酵槽的清潔）。在疫苗的情況，籃狀試驗法被視為是可以接受的。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">肆、清潔過程的確效</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">一、與產品相接觸的設備，必須要專用於一種產品，如要共用設備，必須要有一套經過確效的清潔程序才可，這是一個基本的概念。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">二、在多種產品共用的設備上，清潔方法確效所投入的成本，應該與把此設備永久專用於一種產品的費用，加以評估比較。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">三、設備清潔確效，可以在製程開發臨床用藥實際生產階段同時執行。確效工作必須持續進行，一直到完成量產為止。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">四、測試到清潔為止的觀念，可以用於清潔研究，但是通常被認為是無法接受的。這種觀念是包含有清潔、取樣與測試的順序之重複實施，一直到達成可接受的限量為止。對於已確效過之清潔程序的系統或設備，這種再取樣的實施是不得使用的。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">五、在研究時若當所要清除的物質是具有毒性或者是危險性時，可考慮以模擬這種物質之物理化學性質的產品，取代這類物質進行測試。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">六、來自不同供應商的原料，必需考慮可能會有不同的物理性質及雜質組合。當設計其清潔程序時，這樣的差異必須要加以考慮，因為這些物質可能會表現不同。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">七、所有相關的參數都必須要加以查核，以確保這個終將被運作的清潔過程，是已經確效過的。因此，如果為達成清潔而其關鍵溫度有所需要時，那就必須加以確認。所添加之任何化學藥劑，都必須要對其類型及其添加的量加以確認。清潔劑的濃度與沖洗液的容量及速度，在合適時，也必須要加以評估。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">八、如果使用自動化的程序（就地清潔）時，必須要考慮使用適當的感應器，去監測其關鍵管制站及其參數以及警報點，以確保清潔過程是被嚴格管制的。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">九、清潔過程的確效，必須要以最差狀況為基礎，它包含有：</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">（一）、清潔過程的挑戰，以顯現出挑戰用的污染物，可以有適當的量被回收，或是展示出對數性的移除，以確保清潔過程，確實是把污染物移除到所要求的殘留量。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">（二）、使用減低的清潔參數，諸如加過量之污染物、設備表面之過份乾燥、清潔劑之最低濃度及</span><span style="font-family: calibri;">/</span><span style="font-family: 新細明體,serif;">或清潔劑的最短接觸時間等之使用。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">十、清潔程序必須連續執行三次，並能達預期效果，以證明這個清潔方法是經過確效。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">伍、設備與人員</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">一、所有製程操作設備之設計，應考慮易於清潔及便於目視檢查，且儘可能採用非反應性材質之平滑的表面所製成。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">二、對設備有半自動或全自動化就地清潔系統時，宜使用無球閥的衛生管路，若有採用非衛生性球閥時，其清潔應更加強。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">三、如使用就地清潔系統，特別是採用非衛生性球閥時，操作員必須注意並了解清潔困難度，並接受此系統及閥的清潔訓練、同時必須評估操作員，是否有資格操作此清潔程序。確效文件必須特別指出，此類系統的清潔確效。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">四、在有牽涉到管路轉接的大系統中，必需有流程圖清楚標示閥門位置，以便操作員進行清潔工作，同時可避免錯誤的清潔作業。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">五、檢查重要組件，同時指出製造結束，至每一清潔步驟的時間。對於軟</span><span style="font-family: calibri;">/</span><span style="font-family: 新細明體,serif;">乳膏、懸浮液、原料藥的操作，因殘留物的乾凅，會影響清潔過程效率，這些因素特別重要。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">六、關鍵區域，亦即，最困難去清潔的那些區域，必須要把它確認出，特別是採用半自動，或全自動之就地清潔系統的大型製造設備。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">七、對於很困難去移除的產品，例如，在原料藥生產上的煤焦狀，或黏膠狀的殘留物</span><span style="font-family: calibri;">;</span><span style="font-family: 新細明體,serif;">對於很難清潔的設備，例如，流動床乾燥機的濾袋</span><span style="font-family: calibri;">;</span><span style="font-family: 新細明體,serif;">或者是對於安全性上具有高度危險的產品，例如，低於其可接受限量，可能很困難去檢測的生物性藥物或高效價的產品，其與藥品直接接觸的設備都必須是專用的。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">八、在原料藥的製造過程上，特別是對於非常強效的化學品，例如，某些類固醇，如果其設備不是專用時，則其副產物的問題，是需要加以考慮的。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">九、確效手工清潔程序，亦即，確效一種由於無法避免變異的清潔程序，是很困難的。因此，執行手工清潔程序的操作員，必須定期給予適當的訓練，並予督導之。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">陸、微生物學上的考慮</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">一、不論就地清潔系統是否被使用於製程設備的清潔上，設備之清潔，必須考慮微生物的問題。這主要包含預防性的措施，而非待其發生污染後再去清除。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">二、必須要有文件證明，設備的例行清潔與儲藏，不會讓微生物生長繁殖。例如，設備在儲藏之前，必須加以乾燥，以及設備在清潔作業之後，不論任何情況，都不得容許有不動的水保留在設備上。設備使用後，到清潔開始前之間隔時間，也必須要加以建立。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">三、經由設備之適當清潔與儲藏以控制生物負荷菌，對確保在後來的滅菌或消毒過程，以達成所需之無菌性的保證，是很重要的。從熱原在無菌操作中之管制的立足點來看，這也是特別重要，因為設備的滅菌過程，可能無法適當地達成熱原之顯著去活化或者是移除。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">柒、文件管理</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">一、詳細的清潔程序，應彙集於標準作業程序中。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">二、清潔確效計畫書，必須要敘述，使用於確效清潔過程的程序。除了一般性所應證明資訊外，它還必須包含以下的資訊：所使用設備的描述；生產終了與清潔程序開始之間的間隔時間；對每一種產品、每一個製造系統或每一件設備，所要使用的清潔程序取樣方法；包含最低檢測濃度，與最低定量濃度等分析方法；合格標準及其理論基礎，以及再確效的時機等。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">三、執行各種清潔步驟或程序所需要文件憑證的數量，可視其系統的複雜性，與清潔過程而有所不同。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">四、當需要較為複雜的清潔程序時，把關鍵的清潔步驟，例如，某些原料藥的合成過程，做成文件是必須的。此特定文件，尚須包括關於清潔者、執行的時機，以及此設備操作前批之產品等資訊。惟對於較單純的清潔操作，只要有其所執行過之全面清潔過程的文件憑證，可能就足夠了。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">五、其它的因素，如歷次清潔的相關資料需加註解，清潔後的殘留量及測試結果的變異性，也會影響所需文書的量。例如，已被確認的清潔程序，在清潔後檢測到不同的殘留量，必須進行適當的評估；以建立程序和操作者執行的有效性；當操作者的表現被認為是一個問題時，需要更進一步的指引和訓練。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">捌、分析方法</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">一、檢測殘留物或污染物所使用的分析方法，對於所要執行含量測定的物質，例如，產品殘留物、清潔劑殘留物及</span><span style="font-family: calibri;">/</span><span style="font-family: 新細明體,serif;">或內毒素必須是專一的，而且，必須要在實施清潔確效研究之前，就做好分析方法確效。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">二、分析方法的專一性與靈敏度必須要確立。如果污染物或污染物的殘留量無法被檢測出，它並非意謂清潔之後就沒有殘留的污染物存在。它只是暗示出污染物的量，是低於分析方法的靈敏度或檢測限量而已。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">三、在生物性藥物的情況，使用產品專一性的含量測定方法，可能是不適當的，例如，免疫分析法，去監測生物製劑之滯留。因為一個陰性反應，並不代表其蛋白質含量或殘留量低於管理值，而可能是蛋白質的抗原決定基之變性的結果所致。對於蛋白質殘留量之檢測，除了總有機碳之檢測法外，也可以加測產品專一性的含量測定法。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">四、污染物的分析方法與回收百分率，必須要與所使用的取樣方法一併研究。這是要顯示污染物，可以從設備表面被回收，並且，顯示出回收率以及回收的一致性。在可以以檢品結果為基礎去做任何結論之前，這是需要先做到的。陰性反應也可能會是不良的取樣技術所導致的。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">玖、取樣、洗滌、洗滌檢品與清潔劑</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">一、有兩種取樣的類型，被認為是可以接受的，亦即，直接表面取樣法（擦拭法）及間接取樣法（使用洗滌液去取樣）。通常，這兩種方法的併用是最令人滿意的，特別是在，設備之配件的可接近性，會妨礙直接表面取樣時。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">二、直接表面取樣法</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">（一）、最困難清潔而且可以合理地接近或進入的區域，是可以用表面取樣法去評估，以確認在每一已知表面積上之污染物的殘留量。此外，乾涸的或是不溶性的殘留物，可用物理性的移除法取樣之。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">（二）、所要使用於取樣的材料與取樣媒介質，其適用性必須要加以確定。準確地回收一個檢品的能力，很可能會受到取樣材料之選擇所影響。確保取樣媒介質與溶媒（用於從媒介質上抽取被分析物）為令人滿意，而且是可以很容易使用，是很重要的。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">三、間接取樣法</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">（一）、對大面積採樣，和不能接近的系統，或不能被例行拆解的設備，洗滌取樣法是可用的。不過，必須要考慮到殘留物或污染物，可能是不溶性，或是可能被物理性封閉於設備之中的事實。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">（二）、當洗滌取樣法，被用於確效清潔過程時，必須要做到污染物或殘留物，在適切溶媒中的直接量測。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">四、一旦清潔過程已經做好確效，則間接測試法，例如，導電度法，對某些例行監測可能具有某些價值。這在原料藥廠尤其常見。反應器與離心機，及連接大型設備之間的管線之取樣，只能使用洗滌取樣法去取樣。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">五、如果是使用空白物法，進行確效清潔過程時，因可能期待會均勻地分散在整個系統中，或是被從設備表面均勻地摩擦出來，那是很難提出保證的，所以原則上不推薦此方法。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">六、除了分析方法以外，使用目視檢查法，以確保清潔過程是可接受的，也是很重要的。如是同一產品間的批與批間，或原料藥生產過程中，不同批而同一中間物的不同批之清潔程序，此種清潔程序不需確效，設備只要符合&ldquo;目視檢查&rdquo;的要求即可。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">七、當清潔劑使用在清潔過程中時，使用者必須要瞭解其組成成分，而且，它們的移除，也必須要加以確認。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">八、在清潔過程中使用的清潔劑，必須是要很容易被移除的。在清潔之後，清潔劑殘留物的可接受限量，必須要加以界定。當確效清潔程序時，清潔劑之分解的可能性，也是必須加以考慮的。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">九、與無菌產品相接觸之設備，其清潔程序之最後洗滌上，必須使用注射用水再清洗。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">十、與非無菌產品相接觸之設備，其清潔程序之最後洗滌上，必須使用純淨水再清洗。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">由於不同程度之有機與無機殘留物，以及氯的存在，所以自來水，不得使用與產品相接觸之生產設備的任何清潔程序的最後洗滌上。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">拾、產品殘留限量的訂定</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">一、製造廠對產品殘留物選擇限量的理論基礎，必須要合乎邏輯，並且要以其所涉及的物質，及其治療劑量為基礎。此限量必須是可行、可達成，而且是可確認的。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">二、在建立產品殘留限量時，只把焦點放在主要反應物，可能是不合適的，因為副產物</span><span style="font-family: calibri;">/</span><span style="font-family: 新細明體,serif;">化學變異（活性分解物），可能會更困難去移除。除化學測試之外，薄層層析法的篩選，在某些情況中可能還是需要的。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">三、殘留限量的訂定，至少可考量下列方式：</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">（一）、所有產品之專一性清潔確效。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">（二）、將產品分群及選擇最差狀況。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">（三）、做危險族群之分類，例如，非常易溶的產品、效價相似、高毒性或難檢測者。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">（四）、設定限量於不容許超過殘留的某一比率值。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">（五）、不同劑型有不同安全因子。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">四、產品殘留物管理標準的設定，依下列三項標準中最為嚴格者來設定：</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">（一）、任何產品出現在隨後產品之最大每日劑量的量，不得大於該產品正常治療每日最小劑量的</span><span style="font-family: calibri;">0.1</span><span style="font-family: 新細明體,serif;">％。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">（二）、任何產品出現在另一產品中的量，不得大於</span><span style="font-family: calibri;">10ppm</span><span style="font-family: 新細明體,serif;">。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">（三）、在清潔程序執行之後，沒有目視可見的殘留物在設備上。外加研究法必須要測定其最具活性成分，可以由目視法檢測出的濃度。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">對於某些過敏性藥物，如青黴素類、頭孢子菌素類，或是強效性類固醇與細胞毒劑，其限量必須要比可以獲得之最佳分析方法的檢測限量為低。實際上，這可能意謂，對這些產品是要使用專用的場所去製造。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">附註：某些限量，包括：分析檢測量例如</span><span style="font-family: calibri;">10ppm</span><span style="font-family: 新細明體,serif;">；生物活性量例如正常治療劑量的</span><span style="font-family: calibri;">1/1000</span><span style="font-family: 新細明體,serif;">；以及感官量例如沒有目視可見殘留物等，都已為工業界的代表在文獻上或在發表會上提出。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">環保署與毒理學家建議，一種毒性物質的一個可接受的量，可以是不超過毒性劑量的</span><span style="font-family: calibri;">1/1000</span><span style="font-family: 新細明體,serif;">（不同劑型有不同的安全係數），或是在已知最敏感的動物體系中，已知不會顯現出任何有害的生物效應，例如，無效應之量的</span><span style="font-family: calibri;">1/100</span><span style="font-family: 新細明體,serif;">至</span><span style="font-family: calibri;">1/1000</span><span style="font-family: 新細明體,serif;">。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">拾壹、結論</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">清潔確效計畫必須要依據，詳盡的清潔程序、優良的訓練計畫、確效計畫書、確效好的化學與微生物學的分析方法、變更管制計畫、最終報告，以及確保依從性所要求的任何稽核為基礎。</span> </p><p><span style="font-family: 新細明體,serif;">中英名詞對照</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">不動的水</span> </p><p><span style="font-family: calibri;">Stagnant water</span></p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">可接近性</span> </p><p><span style="font-family: calibri;">Accessibility</span></p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">外加研究法</span> </p><p><span style="font-family: calibri;">Spiking study</span></p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">抗原決定基</span> </p><p><span style="font-family: calibri;">Epitope</span></p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">依從性</span> </p><p><span style="font-family: calibri;">Compliance</span></p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">注射用水</span> </p><p><span style="font-family: calibri;">Water for injection</span></p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">物理性封閉</span> </p><p><span style="font-family: calibri;">Physically occluded</span></p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">空白物法</span> </p><p><span style="font-family: calibri;">Placebo method</span></p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">青黴素類</span> </p><p><span style="font-family: calibri;">Penicillins</span></p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">非反應性材質</span> </p><p><span style="font-family: calibri;">Non-reactive material</span></p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">洗滌劑</span> </p><p><span style="font-family: calibri;">Cleaning agent</span></p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">純淨水</span> </p><p><span style="font-family: calibri;">Purified water</span></p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">清潔劑</span> </p><p><span style="font-family: calibri;">Detergent</span></p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">細胞毒劑</span> </p><p><span style="font-family: calibri;">Cytotoxic</span></p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">最低定量濃度</span> </p><p><span style="font-family: calibri;">Limit of quantitation</span></p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">最低檢測濃度</span> </p><p><span style="font-family: calibri;">Limit of detection</span></p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">最差狀況</span> </p><p><span style="font-family: calibri;">Worst-case scenario</span></p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">媒介質</span> </p><p><span style="font-family: calibri;">Medium</span></p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">就地清潔</span> </p><p><span style="font-family: calibri;">Clean-in place</span></p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">減低的清潔參數</span> </p><p><span style="font-family: calibri;">Reduced cleaning parameter</span></p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">測試到清潔為止</span> </p><p><span style="font-family: calibri;">Test until clean</span></p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">無效應</span> </p><p><span style="font-family: calibri;">No effect</span></p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">荷爾蒙</span> </p><p><span style="font-family: calibri;">Hormone</span></p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">間隔時間</span> </p><p><span style="font-family: calibri;">Time frame</span></p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">對數性的移除</span> </p><p><span style="font-family: calibri;">Log removal</span></p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">滯留</span> </p><p><span style="font-family: calibri;">Carry over</span></p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">盤尼西林</span> </p><p><span style="font-family: calibri;">Penicillin</span></p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">頭孢子菌素類</span> </p><p><span style="font-family: calibri;">Cephalosporins</span></p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">薄層層析法</span> </p><p><span style="font-family: calibri;">Thin layer chromatography</span></p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">籃狀試驗法</span> </p><p><span style="font-family: calibri;">Bracketing</span></p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">雜質組合</span> </p><p><span style="font-family: calibri;">Impurity profile</span></p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">類固醇</span> </p><p><span style="font-family: calibri;">Steroid</span></p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">警報點</span> </p><p><span style="font-family: calibri;">Alarm point</span></p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">英中名詞對照</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: calibri;">Accessibility</span></p><p><span style="font-family: 新細明體,serif;">可接近性</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: calibri;">Alarm point</span></p><p><span style="font-family: 新細明體,serif;">警報點</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: calibri;">Bracketing</span></p><p><span style="font-family: 新細明體,serif;">籃狀試驗法</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: calibri;">Carry over</span></p><p><span style="font-family: 新細明體,serif;">滯留</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: calibri;">Cephalosporins</span></p><p><span style="font-family: 新細明體,serif;">頭孢子菌素類</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: calibri;">Clean-in place</span></p><p><span style="font-family: 新細明體,serif;">就地清潔</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: calibri;">Cleaning agent</span></p><p><span style="font-family: 新細明體,serif;">洗滌劑</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: calibri;">Compliance</span></p><p><span style="font-family: 新細明體,serif;">依從性</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: calibri;">Cytotoxic</span></p><p><span style="font-family: 新細明體,serif;">細胞毒劑</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: calibri;">Detergent</span></p><p><span style="font-family: 新細明體,serif;">清潔劑</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: calibri;">Epitope</span></p><p><span style="font-family: 新細明體,serif;">抗原決定基</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: calibri;">Hormone</span></p><p><span style="font-family: 新細明體,serif;">荷爾蒙</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: calibri;">Impurity profile</span></p><p><span style="font-family: 新細明體,serif;">雜質組合</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: calibri;">Limit of detection</span></p><p><span style="font-family: 新細明體,serif;">最低檢測濃度</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: calibri;">Limit of quantitation</span></p><p><span style="font-family: 新細明體,serif;">最低定量濃度</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: calibri;">Log removal</span></p><p><span style="font-family: 新細明體,serif;">對數性的移除</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: calibri;">Medium</span></p><p><span style="font-family: 新細明體,serif;">媒介質</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: calibri;">No effect</span></p><p><span style="font-family: 新細明體,serif;">無效應</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: calibri;">Non-reactive material</span></p><p><span style="font-family: 新細明體,serif;">非反應性材質</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: calibri;">Penicillin</span></p><p><span style="font-family: 新細明體,serif;">盤尼西林</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: calibri;">Penicillins</span></p><p><span style="font-family: 新細明體,serif;">青黴素類</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: calibri;">Physically occluded</span></p><p><span style="font-family: 新細明體,serif;">物理性封閉</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: calibri;">Placebo method</span></p><p><span style="font-family: 新細明體,serif;">空白物法</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: calibri;">Purified water</span></p><p><span style="font-family: 新細明體,serif;">純淨水</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: calibri;">Reduced cleaning parameter</span></p><p><span style="font-family: 新細明體,serif;">減低的清潔參數</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: calibri;">Spiking study</span></p><p><span style="font-family: 新細明體,serif;">外加研究法</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: calibri;">Stagnant water</span></p><p><span style="font-family: 新細明體,serif;">不動的水</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: calibri;">Steroid</span></p><p><span style="font-family: 新細明體,serif;">類固醇</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: calibri;">Test until clean</span></p><p><span style="font-family: 新細明體,serif;">測試到清潔為止</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: calibri;">Thin layer chromatography</span></p><p><span style="font-family: 新細明體,serif;">薄層層析法</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: calibri;">Time frame</span></p><p><span style="font-family: 新細明體,serif;">間隔時間</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: calibri;">Water for injection</span></p><p><span style="font-family: 新細明體,serif;">注射用水</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: calibri;">Worst-case scenario</span></p><p><span style="font-family: 新細明體,serif;">最差狀況</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p> 2013-12-04
1420528 化學製造管制類,指導手冊,現行藥品優良製造規範-電腦化系統確效指導手冊 行政解釋 現行藥品優良製造規範-電腦化系統確效指導手冊 詳如附件 2013-12-04 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4520&type=0
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1420539 化學製造管制類,指導手冊,滅菌過程確效指導手冊 行政解釋 滅菌過程確效指導手冊 <p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">「滅菌過程確效指導手冊」</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">目</span><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">錄</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">第一章</span><span style="font-size: 10pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">前言．．．．．．．．．．．．．．．．．．．．．．．．．．</span><span style="font-size: 10pt;"> 1</span></p><p><span style="font-family: 標楷體; font-size: 10pt;">第二章</span><span style="font-size: 10pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">最終蒸氣滅菌過程．．．．．．．．．．．．．．．．．．．．</span><span style="font-size: 10pt;"> 1</span></p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">一、製程及成品資炓．．．．．．．．．．．．．．．．．．．</span><span style="font-size: 10pt;"> 2</span></p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">二、滅菌過程的熱研究．．．．．．．．．．．．．．．．．．</span><span style="font-size: 10pt;"> 3</span></p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">三、滅菌效果的研究．．．．．．．．．．．．．．．．．．．</span><span style="font-size: 10pt;"> 4</span></p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">四、環境微生物的管制．．．．．．．．．．．．．．．．．．</span><span style="font-size: 10pt;"> 6</span></p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">五、容器、封蓋與包裝的密封完整性．．．．．．．．．．．．</span><span style="font-size: 10pt;"> 6</span></p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">六、細菌內毒素試驗方法．．．．．．．．．．．．．．．．．</span><span style="font-size: 10pt;"> 7</span></p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">七、無菌試驗及放行規格．．．．．．．．．．．．．．．．．</span><span style="font-size: 10pt;"> 7</span></p><p><span style="font-family: 標楷體; font-size: 10pt;">第三章</span><span style="font-size: 10pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">其他的最終滅菌過程．．．．．．．．．．．．．．．．．．．</span><span style="font-size: 10pt;"> 7</span></p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">一、環氧乙烯．．．．．．．．．．．．．．．．．．．．．．</span><span style="font-size: 10pt;"> 8</span></p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">二、放射線．．．．．．．．．．．．．．．．．．．．．．．</span><span style="font-size: 10pt;"> 9</span></p><p><span style="font-family: 標楷體; font-size: 10pt;">第四章</span><span style="font-size: 10pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">無菌充填．．．．．．．．．．．．．．．．．．．．．．．．</span><span style="font-size: 10pt;">10</span></p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">一、廠房與設施．．．．．．．．．．．．．．．．．．．．．</span><span style="font-size: 10pt;">10</span></p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">二、製程概說．．．．．．．．．．．．．．．．．．．．．．</span><span style="font-size: 10pt;">11</span></p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">三、容器、封蓋、設備及原料的滅菌與去熱原．．．．．．．．</span><span style="font-size: 10pt;">12</span></p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">四、培養基充填試驗．．．．．．．．．．．．．．．．．．．</span><span style="font-size: 10pt;">13</span></p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">五、培養基充填試驗失敗時有關成品的處置．．．．．．．．．</span><span style="font-size: 10pt;">14</span></p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">六、環境微生物的管制．．．．．．．．．．．．．．．．．．</span><span style="font-size: 10pt;">14</span></p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">七、容器、封蓋與包裝的密封完整性．．．．．．．．．．．．</span><span style="font-size: 10pt;">15</span></p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">八、細菌內毒素試驗方法．．．．．．．．．．．．．．．．．</span><span style="font-size: 10pt;">16</span></p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">九、無菌試驗及放行規格．．．．．．．．．．．．．．．．．</span><span style="font-size: 10pt;">16</span></p><p><span style="font-family: 標楷體; font-size: 10pt;">第五章</span><span style="font-size: 10pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">微生物管制與品質維護．．．．．．．．．．．．．．．．．．</span><span style="font-size: 10pt;">16</span></p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">一、容器與封蓋組合的密封性．．．．．．．．．．．．．．．</span><span style="font-size: 10pt;">16</span></p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">二、防腐劑的效果．．．．．．．．．．．．．．．．．．．．</span><span style="font-size: 10pt;">17</span></p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">三、熱原或細菌內毒素試驗．．．．．．．．．．．．．．．．</span><span style="font-size: 10pt;">17</span></p><p><span style="font-family: 標楷體; font-size: 10pt;">第</span> <span style="font-family: 標楷體; font-size: 10pt;">一</span> <span style="font-family: 標楷體; font-size: 10pt;">章</span><span style="font-size: 10pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">前</span><span style="font-size: 10pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">言</span> </p><p><span style="font-size: 10pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">依據優良藥品製造標準規定，為避免無菌產品受到微生物的污染，應訂有書面作業程</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">序並確實遵守。這些作業程序應包括所有滅菌過程的確效。</span> </p><p><span style="font-size: 10pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">滅菌過程確效是根據一系列的實驗計劃書及實驗結果來確認滅菌過程的有效性，其結</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">果應顯示此滅菌過程及相關的管制及操作標準可以用來重覆製造出符合無菌品質的藥品。</span> </p><p><span style="font-size: 10pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">不論藥廠是使用最終滅菌</span><span style="font-size: 10pt;"> (TERMINAL STERILIZATION) </span><span style="font-family: 標楷體; font-size: 10pt;">或是無菌操作方式</span> </p><p><span style="font-size: 10pt;">(ASEPTIC OPERATIONS) </span><span style="font-family: 標楷體; font-size: 10pt;">來製造無菌產品，其製造過程均應提供適當的確效資料。</span> </p><p><span style="font-size: 10pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">滅菌過程的確效可以用適當之媒介物代替，不需一定要用實際的產品試驗三批來判定。</span> </p><p><span style="font-size: 10pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">滅菌過程確效之狀況及條件應與正式生產時一樣，如此取得之數據才能代表並證明實</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">際產品之無菌性。</span> </p><p><span style="font-size: 10pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">本滅菌過程確效指導手冊（以下簡稱本手冊），目的在於提供無菌藥品在無菌確效過</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">程之範圍與要求，作為業者製造無菌製劑執行無菌確效之參考。</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">第</span> <span style="font-family: 標楷體; font-size: 10pt;">二</span> <span style="font-family: 標楷體; font-size: 10pt;">章</span><span style="font-size: 10pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">最終蒸氣滅菌過程</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">一、製程及成品資料</span> </p><p><span style="font-size: 10pt;">&nbsp; 1.</span><span style="font-family: 標楷體; font-size: 10pt;">成品及容器封蓋組合系統：</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">說明需滅菌的成品及容器封蓋組合</span><span style="font-size: 10pt;">,</span><span style="font-family: 標楷體; font-size: 10pt;">如大小、充填量或包裝。</span> </p><p><span style="font-size: 10pt;">&nbsp; 2.</span><span style="font-family: 標楷體; font-size: 10pt;">滅菌過程：</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; 1)</span><span style="font-family: 標楷體; font-size: 10pt;">說明被滅菌物包括藥品於最終容器封蓋組合內、以及原料藥、半製品及相關物品</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">等所使用的滅菌過程。</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; 2)</span><span style="font-family: 標楷體; font-size: 10pt;">提出證明滅菌過程效果的資料及數據（參見第二章二或第二章三）。</span> </p><p><span style="font-size: 10pt;">&nbsp; 3.</span><span style="font-family: 標楷體; font-size: 10pt;">滅菌器滅菌過程及操作規格：</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; 1)</span><span style="font-family: 標楷體; font-size: 10pt;">說明滅菌器的操作過程，諸如滅菌種類（如使用飽合蒸氣、浸水或噴水方式），</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">並註明所使用的滅菌器及其製造商、型號等。</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; 2)</span><span style="font-family: 標楷體; font-size: 10pt;">說明滅菌條件及規格（如溫度、壓力、時間及最低、最高</span><span style="font-size: 10pt;">FO</span><span style="font-family: 標楷體; font-size: 10pt;">值等）。</span> </p><p><span style="font-size: 10pt;">&nbsp; 4.</span><span style="font-family: 標楷體; font-size: 10pt;">裝戴型式：</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">說明具代表性的滅菌器裝載型式。（附圖表說明）</span> </p><p><span style="font-size: 10pt;">&nbsp; 5.</span><span style="font-family: 標楷體; font-size: 10pt;">監控方法：</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">說明於例行性生產時監控滅菌製程的方法（如使用熱探測器、試驗瓶、生物或化學</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">性指示劑），並註明其數量、擺放位置及判定規格等。</span> </p><p><span style="font-size: 10pt;">&nbsp; 6.</span><span style="font-family: 標楷體; font-size: 10pt;">生產用滅菌器的再確效：</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">對生產用的滅菌器應制訂再確效計畫。</span> </p><p><span style="font-size: 10pt;">&nbsp; 7.</span><span style="font-family: 標楷體; font-size: 10pt;">再處理：</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">對再度處理的產品（如再次加熱滅菌）應制訂確效計畫書，說明其確效的過程，並</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">注意再次的加熱滅菌是否會影響該成品的定定性。</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">二、滅菌過程的熱研究</span> </p><p><span style="font-size: 10pt;">&nbsp; 1.</span><span style="font-family: 標楷體; font-size: 10pt;">溫度分佈與熱滲透試驗：</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; 1)</span><span style="font-family: 標楷體; font-size: 10pt;">提出滅菌過程有關溫度分佈與熱滲透的實驗計畫書及實驗結果，這些結果可證明</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">滅菌過程的均一性，再現性並符合制訂的規格。</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; 2)</span><span style="font-family: 標楷體; font-size: 10pt;">滅菌確效紀錄應有連續三次成功的結果，以確保滅菌過程的一致性。</span> </p><p><span style="font-size: 10pt;">&nbsp; 2.</span><span style="font-family: 標楷體; font-size: 10pt;">熱探測器：</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">說明熱探測器放置於滅菌器的位置及數量。（附圖表說明）熱探測器在使用之前，</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">應進行校正以確保實驗之正確性。</span> </p><p><span style="font-size: 10pt;">&nbsp; 3.</span><span style="font-family: 標楷體; font-size: 10pt;">裝載對熱傳導的影響：</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; 1)</span><span style="font-family: 標楷體; font-size: 10pt;">最小及最大裝載量的研究數據以探討裝載量多寡，對熱輸入成品的影響。</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">如果容器相同但充填量不同則要做進一步試驗紀錄。</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; 2)</span><span style="font-family: 標楷體; font-size: 10pt;">紀錄要包括最高及最低溫度（溫度範圍），維持滅菌溫度停留期間的平均溫度，</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">最高、最低</span><span style="font-size: 10pt;">FO</span><span style="font-family: 標楷體; font-size: 10pt;">值，達到滅菌溫度的時間，試驗的日期及時間，使用滅菌器的型號</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">等。</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; 3)</span><span style="font-family: 標楷體; font-size: 10pt;">這些試驗所使用的滅菌器應與製造成品時所使用的相同。</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">三、滅菌效果的研究</span><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; -6</span></p><p><span style="font-size: 10pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">‧任何最終滅菌過程的無菌保證應優於</span><span style="font-size: 10pt;">10&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">的無菌保證。這種標準的無菌保證應適用</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">於成品所有的無菌組成部分，包括容器及封蓋。</span> </p><p><span style="font-size: 10pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">‧這些滅菌方法係依產品及製程的特性而設計，不同藥廠，可能使用不同的方法，但</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">通常要提供左列的資料。</span> </p><p><span style="font-size: 10pt;">&nbsp; 1.</span><span style="font-family: 標楷體; font-size: 10pt;">負荷菌（</span><span style="font-size: 10pt;">BIOBURDEN ORGANISM</span><span style="font-family: 標楷體; font-size: 10pt;">）的特性：</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; 1)</span><span style="font-family: 標楷體; font-size: 10pt;">使用依微生物負荷量多寡而制訂的滅菌法較使用過度滅菌法需要更多的資料，來</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">保證滅菌之完整。</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; 2)</span><span style="font-family: 標楷體; font-size: 10pt;">提供的資料包括負荷菌的種類、數量、及耐受性，應包括可能來自藥液，容器及</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">封蓋之微生物。</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; 3)</span><span style="font-family: 標楷體; font-size: 10pt;">說明鑑別負荷菌特性的方法及結果。必要時需鑑別耐熱性最強的負荷菌。</span> </p><p><span style="font-size: 10pt;">&nbsp; 2.</span><span style="font-family: 標楷體; font-size: 10pt;">負荷菌的規格：</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; 1)</span><span style="font-family: 標楷體; font-size: 10pt;">提供負荷菌旳警告與行動界限規格。</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; 2)</span><span style="font-family: 標楷體; font-size: 10pt;">說明例行監控負荷菌的計畫以保證負荷菌在確效所設定的規格範圍內，計畫內容</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">包括正確之試驗方法與頻率。</span> </p><p><span style="font-size: 10pt;">&nbsp; 3.</span><span style="font-family: 標楷體; font-size: 10pt;">生物指示劑的鑑定，耐受性及安定性：</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; 1)</span><span style="font-family: 標楷體; font-size: 10pt;">滅菌確效所使用的生物指示劑，應提供其鑑別耐受性（</span><span style="font-size: 10pt;">D</span><span style="font-family: 標楷體; font-size: 10pt;">值，</span><span style="font-size: 10pt;">Z</span><span style="font-family: 標楷體; font-size: 10pt;">值）及安定性的資</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">料。</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; 2)</span><span style="font-family: 標楷體; font-size: 10pt;">如果生物指示劑是購自市面，必要時應該證實其荷菌數和耐受性，及實際操作的</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">規格。</span> </p><p><span style="font-size: 10pt;">&nbsp; 4.</span><span style="font-family: 標楷體; font-size: 10pt;">生物指示劑的耐受性與負荷菌的關係：</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; 1)</span><span style="font-family: 標楷體; font-size: 10pt;">說明生物指示劑的特性與負荷菌的關係。</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; 2)</span><span style="font-family: 標楷體; font-size: 10pt;">依產品的狀況測定微生物在藥液內或附於容器、封蓋表面對滅菌過程的耐受性。</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; 3)</span><span style="font-family: 標楷體; font-size: 10pt;">如果使用孢子攜片必要時研究孢子置於攜片上與直接植入產品的差異。</span> </p><p><span style="font-size: 10pt;">&nbsp; 5.</span><span style="font-family: 標楷體; font-size: 10pt;">微生物挑戰實驗：</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">提出的微生物挑戰確效試驗必須能證明產品在最難滅菌的條件下</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; -6</span></p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">（如在最難滅菌的裝載產品及位置），能得到優於</span><span style="font-size: 10pt;">10&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">的無菌保證。</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">所稱最難滅菌的產品或位置係經由實驗得到的。</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">四、環境微生物的管制</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">需制訂製造場所、原料及製造用水等的微生物管制計畫。此計畫應包含適當的規格</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">、標準、取樣計畫、測試方法、測試頻率及行動界限。並按計畫實施保留數據。</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">五、容器、封蓋與包裝的密封完整性</span> </p><p><span style="font-size: 10pt;">&nbsp; 1.</span><span style="font-family: 標楷體; font-size: 10pt;">加工過程中所受外部壓力的模擬試驗：</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">實驗設計應模擬藥品在滅菌過程、搬運、儲存時所受外力對容器封蓋組合的影響，</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">需要時可用物理性、化學性及生物性的挑戰試驗。</span> </p><p><span style="font-size: 10pt;">&nbsp; 2.</span><span style="font-family: 標楷體; font-size: 10pt;">最嚴苛的滅菌條件：</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; 1)</span><span style="font-family: 標楷體; font-size: 10pt;">應使用最長的滅菌製程來測試容器、封蓋的密封完整性。</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; 2)</span><span style="font-family: 標楷體; font-size: 10pt;">如果成品經過一次以上的滅菌，則在試驗設計應包含所有的滅菌過程。</span> </p><p><span style="font-size: 10pt;">&nbsp; 3.</span><span style="font-family: 標楷體; font-size: 10pt;">多重阻隔（</span><span style="font-size: 10pt;">MULTIPLE BARRIERS</span><span style="font-family: 標楷體; font-size: 10pt;">）：</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">成品的每一阻隔如標示無菌時，應個別加以確效。</span> </p><p><span style="font-size: 10pt;">&nbsp; 4.</span><span style="font-family: 標楷體; font-size: 10pt;">試驗靈敏度：</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">應提供測試容器、封蓋密封性方法的靈敏度。</span> </p><p><span style="font-size: 10pt;">&nbsp; 5.</span><span style="font-family: 標楷體; font-size: 10pt;">成品有效期間或保存期限內的密封完整性。</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">檢測成品在有效期間或保存期限內防止微生物污染的密封完整性。</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">六、細菌內毒素試驗方法</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">說明成品內毒素測試的方法：內容應包括實驗室設備及操作環境的適合性，成品對</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">內毒素抑制或增強的試驗及結果。檢測無抑制時的濃度及最大有效稀釋倍數。</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">七、無菌試驗及放行規格</span> </p><p><span style="font-size: 10pt;">&nbsp; 1.</span><span style="font-family: 標楷體; font-size: 10pt;">實驗計畫書內應說明於生產時如何選擇代表性樣品來做無菌試驗。</span> </p><p><span style="font-size: 10pt;">&nbsp; 2.</span><span style="font-family: 標楷體; font-size: 10pt;">說明在阻隔系統（</span><span style="font-size: 10pt;">BARRIER SYSTEMS</span><span style="font-family: 標楷體; font-size: 10pt;">）內操作無菌試驗的方法。</span> </p><p><span style="font-size: 10pt;">&nbsp; 3.</span><span style="font-family: 標楷體; font-size: 10pt;">有關阻隔系統的確效試驗視需要得一併提出。</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">第</span> <span style="font-family: 標楷體; font-size: 10pt;">三</span> <span style="font-family: 標楷體; font-size: 10pt;">章</span><span style="font-size: 10pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">其他的最終滅菌過程</span> </p><p><span style="font-size: 10pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">上述第二章一至七的規定係說明蒸氣的滅菌過程，但其他如成品、包材或原料以單獨</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">或合併方式利用環氧乙烯或放射線（伽瑪射線）滅菌時亦適用之。</span><span style="font-size: 10pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">其滅菌過程確效需</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">包括裝載型式、最大裝載量的確效；最低滅菌條件測定最不易滅菌地方，以確保成品無</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">菌。滅菌過程的再確效、再滅菌的規定；產品負荷菌的規格及管制計畫，容器封蓋組合</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">密封性等，以及滅菌製程對藥品物理性或化學性的影響。</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">一、環氧乙烯</span> </p><p><span style="font-size: 10pt;">&nbsp; 1.</span><span style="font-family: 標楷體; font-size: 10pt;">滅菌器：</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">說明滅菌器的規格及操作方法，並註明裝有成品時預加濕及導入氣體的控制位置</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">（附圖說明）</span> </p><p><span style="font-size: 10pt;">&nbsp; 2.</span><span style="font-family: 標楷體; font-size: 10pt;">滅菌條件：</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; 1)</span><span style="font-family: 標楷體; font-size: 10pt;">說明滅菌過程的每一階段，如預先加濕，滅菌氣體的濃度、真空及氣體加壓過程</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">、滅菌的時間及溫度、濕度，排除滅菌氣體，置換空氣及化學殘留物的測定等都</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">需要有明確的規定。</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; 2)</span><span style="font-family: 標楷體; font-size: 10pt;">制訂滅菌過程管制的標準作業，以確保於實際生產時的滅菌條件符合於確效所定</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">的規格範圍內。</span> </p><p><span style="font-size: 10pt;">&nbsp; 3.</span><span style="font-family: 標楷體; font-size: 10pt;">微生物法：</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">說明在確效試驗時將孢子置入樣品內測試滅菌效果的微生物測試方法，例如所使用</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">的培養基，培養溫度及培養期間等，同時實際生產時使用的微生物測試法亦應加以</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">說明。</span> </p><p><span style="font-size: 10pt;">&nbsp; 4.</span><span style="font-family: 標楷體; font-size: 10pt;">安定性：</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">藥品於有效期限內應制訂偵測包裝的安定性及容器、封蓋組合密封性的計畫書。</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">二、放射線</span> </p><p><span style="font-size: 10pt;">&nbsp; 1.</span><span style="font-family: 標楷體; font-size: 10pt;">滅菌的設施及過程：</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; 1)</span><span style="font-family: 標楷體; font-size: 10pt;">標明放射線滅菌設施。（附圖說明）</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; 2)</span><span style="font-family: 標楷體; font-size: 10pt;">說明放射線源，與放射線照射的方法（即在照射室內的移動），及用來偵測量產</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">照射所使用放射線劑量計的型式及位置。如果低劑量位置並不是用來作為日常量</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">產偵測的位置，則數據比率介於高與低劑量位置的關係需先了解。</span> </p><p><span style="font-size: 10pt;">&nbsp; 2.</span><span style="font-family: 標楷體; font-size: 10pt;">成品的包裝：</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">說明成品置於包裝箱或在滅菌箱的排列方式。</span> </p><p><span style="font-size: 10pt;">&nbsp; 3.</span><span style="font-family: 標楷體; font-size: 10pt;">多次劑量圖示研究：</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">為顯示滅菌過程之均一性及再現性，應該進行多次劑量之分析研究以求高劑量與低</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">劑量之方位，並以圖示方式說明。</span> </p><p><span style="font-size: 10pt;">&nbsp; 4.</span><span style="font-family: 標楷體; font-size: 10pt;">微生物法：</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">制訂確效及查核滅菌過程效果的微生物方法及管制方式。</span> </p><p><span style="font-size: 10pt;">&nbsp; 5.</span><span style="font-family: 標楷體; font-size: 10pt;">安定性：</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">成品在有效期間或保存期限內，應制訂偵測包裝的安定性及容器封蓋組合密封性的</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">計畫書。</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">第</span> <span style="font-family: 標楷體; font-size: 10pt;">四</span> <span style="font-family: 標楷體; font-size: 10pt;">章</span><span style="font-size: 10pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">無菌充填</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">一、廠房與設施</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">略述製造廠房與設施。</span> </p><p><span style="font-size: 10pt;">&nbsp; 1.</span><span style="font-family: 標楷體; font-size: 10pt;">平面圖：</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; 1)</span><span style="font-family: 標楷體; font-size: 10pt;">無菌充填設施的平面圖包括準備與儲存區，過濾與充填區，以及無菌更衣室。</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; 2)</span><span style="font-family: 標楷體; font-size: 10pt;">標示每個區的空氣清淨度等級（如</span><span style="font-size: 10pt;">100,10000,100000</span><span style="font-family: 標楷體; font-size: 10pt;">級等）。</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; 3)</span><span style="font-family: 標楷體; font-size: 10pt;">標示隔離空間或防護系統位置（</span><span style="font-size: 10pt;">ISOLATOR OR BARRIER</span><span style="font-family: 標楷體; font-size: 10pt;">）。</span> </p><p><span style="font-size: 10pt;">&nbsp; 2.</span><span style="font-family: 標楷體; font-size: 10pt;">設備位置：</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; 1)</span><span style="font-family: 標楷體; font-size: 10pt;">標示重要設備的位置，如層流裝置、滅菌器、凍晶設備及充填設備等。（應標示</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">於平面圖上）。</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; 2)</span><span style="font-family: 標楷體; font-size: 10pt;">註明放置於隔離或防護系統內的設備。</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">二、製程概說</span> </p><p><span style="font-size: 10pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">‧說明製造過程中，如物流、充填、封蓋、無菌組合等。</span> </p><p><span style="font-size: 10pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">‧於上述的平面圖上標示產品從調配至製成品的流程。</span> </p><p><span style="font-size: 10pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">‧製造過程應考慮左列的各項：</span> </p><p><span style="font-size: 10pt;">&nbsp; 1.</span><span style="font-family: 標楷體; font-size: 10pt;">藥液的過濾：</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; 1)</span><span style="font-family: 標楷體; font-size: 10pt;">說明藥液的過濾流程，包括濾器的先後順序、預濾膜、及細菌濾膜等操作細節。</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; 2)</span><span style="font-family: 標楷體; font-size: 10pt;">摘要說明濾膜除菌的效果及成品與濾膜配合性的確效資料。說明濾膜對成品處方</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">的影響，如防腐劑或主成分是否會被濾膜吸附或濾膜釋出物對成品的影響。</span> </p><p><span style="font-size: 10pt;">&nbsp; 2.</span><span style="font-family: 標楷體; font-size: 10pt;">儲存期間的規定：</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">依優良藥品製造標準規定所製造成品應制訂每一重要階段完成的時限，以確保成品</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">品質。所以從藥品的調配到充填至最終容器的每一段儲存期間都要制訂規格，規格</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">中包括儲存容器、儲存溫度、時間及儲存條件等。同時也要說明在儲存期間如何防</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">止微生物污染的方法等，上述方法要加以確認。</span> </p><p><span style="font-size: 10pt;">&nbsp; 3.</span><span style="font-family: 標楷體; font-size: 10pt;">關鑑性操作：</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">說明成品或成品接觸的表面曝露於環境時（如搬運已滅菌的容器或封蓋至無菌充填</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">區）的操作方法，並說明所採用之隔離或防護系統。</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">三、容器、封蓋、設備及原料的滅菌與去熱原</span> </p><p><span style="font-size: 10pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">‧說明容器、封蓋、各組件及防護系統的滅菌與去熱原過程。</span> </p><p><span style="font-size: 10pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">‧說明這些過程的確效試驗包括熱分佈與熱滲透。摘要說明微生物的挑戰試驗（微生</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">物指示劑及內毒素）及例行的管制程序等。</span> </p><p><span style="font-size: 10pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">‧如有蒸氣滅菌以外的滅菌過程也要提出確效資料。</span> </p><p><span style="font-size: 10pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">‧提出每一種滅菌過程所用的殺菌物質（</span><span style="font-size: 10pt;">STERILANT </span><span style="font-family: 標楷體; font-size: 10pt;">）的分佈與滲透及確認滅菌效果</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">的方法（可參見第二章），數據等資料。</span> </p><p><span style="font-size: 10pt;">&nbsp; 1.</span><span style="font-family: 標楷體; font-size: 10pt;">藥液的原料分別滅菌時：</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">如果藥液的各個原料是分別滅菌再經無菌調配，則需提供各個滅菌製程的確效資料。</span> </p><p><span style="font-size: 10pt;">&nbsp; 2.</span><span style="font-family: 標楷體; font-size: 10pt;">批次紀錄上的滅菌資料：</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">申請時在完整的批次紀錄上任何容器封蓋組件，如經滅菌或去熱原製程應標示其</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">確效過程。確效資料可於批次紀錄上載明參閱確效實驗計畫或標準書面作業程序。</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">四、培養基充填試驗</span> </p><p><span style="font-size: 10pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">‧說明培養基充填試驗的操作步驟及規格。</span> </p><p><span style="font-size: 10pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">‧使用與成品相同的充填步驟及容器封蓋組合來做確效試驗，說明所使用的微生物試</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">驗方法。</span> </p><p><span style="font-size: 10pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">‧如果培養基充填試驗與產品的製程上有任何差異，要加以註明。</span> </p><p><span style="font-size: 10pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">‧提供最近培養基充填試驗的摘要紀錄，包括失敗紀錄。</span> </p><p><span style="font-size: 10pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">‧使用與成品生產時相同的生產線取得之實驗數據。</span> </p><p><span style="font-size: 10pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">‧每一次培養基充填試驗的摘要報告應提供左列資料：</span> </p><p><span style="font-size: 10pt;">&nbsp; 1.</span><span style="font-family: 標楷體; font-size: 10pt;">充填室：</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">依本手冊第四章一、</span><span style="font-size: 10pt;">(1)</span><span style="font-family: 標楷體; font-size: 10pt;">之平面圖，標示所使用的無菌室。</span> </p><p><span style="font-size: 10pt;">&nbsp; 2.</span><span style="font-family: 標楷體; font-size: 10pt;">容器、封蓋的形式與大小。</span> </p><p><span style="font-size: 10pt;">&nbsp; 3.</span><span style="font-family: 標楷體; font-size: 10pt;">每一容器之培養基充填量。</span> </p><p><span style="font-size: 10pt;">&nbsp; 4.</span><span style="font-family: 標楷體; font-size: 10pt;">使用何種培養基。</span> </p><p><span style="font-size: 10pt;">&nbsp; 5.</span><span style="font-family: 標楷體; font-size: 10pt;">充填支數。</span> </p><p><span style="font-size: 10pt;">&nbsp; 6.</span><span style="font-family: 標楷體; font-size: 10pt;">培養支數。</span> </p><p><span style="font-size: 10pt;">&nbsp; 7.</span><span style="font-family: 標楷體; font-size: 10pt;">被污染的支數。</span> </p><p><span style="font-size: 10pt;">&nbsp; 8.</span><span style="font-family: 標楷體; font-size: 10pt;">培養條件：</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">說明每一組的培養時間與溫度，如果培養的溫度超過二種時要記明其規格。</span> </p><p><span style="font-size: 10pt;">&nbsp; 9.</span><span style="font-family: 標楷體; font-size: 10pt;">充填日期。</span> </p><p><span style="font-size: 10pt;">&nbsp;10.</span><span style="font-family: 標楷體; font-size: 10pt;">模擬：</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">操作紀錄必需說明所模擬的操作程序是正常操作那一步驟，這些模擬包括較慢的充</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">填速度，人員換班，設備的異常及修理，以及模擬凍晶過程及容器內上方氣體的置</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">換等。</span> </p><p><span style="font-size: 10pt;">&nbsp;11.</span><span style="font-family: 標楷體; font-size: 10pt;">微生物管制：</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">說明於培養基充填試驗時，微生物管制的資料（參考本手冊第四章六）。</span> </p><p><span style="font-size: 10pt;">&nbsp;12.</span><span style="font-family: 標楷體; font-size: 10pt;">充填過程的參數（</span><span style="font-size: 10pt;">PARAMETERS</span><span style="font-family: 標楷體; font-size: 10pt;">）</span><span style="font-size: 10pt;">:</span></p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">比較產品充填時與培養基充填時所使用條件是否相同，如充填線的充填速度、充填</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">量、充填支數、及充填期間等。</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">五、培養基充填試驗失敗時有關成品的處置</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">說明失敗前後成品的處置，有關調查、評估資料及判定（放行或拒絕）依據等。</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">六、環境微生物的管制</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">說明正常生產與培養基充填試驗時的微生物管制計畫，計畫包括管制的種類、頻率</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">、地點、警告與判定規格及超過規格時所採取的措施。</span> </p><p><span style="font-size: 10pt;">&nbsp; 1.</span><span style="font-family: 標楷體; font-size: 10pt;">微物管制的方法</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">‧說明環境管制計畫所使用的方法及材料</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">‧方法包括取樣、運送、消毒劑的中和、培養及結果的計算等。</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">‧說明左列微生物污染源的管制規格及其方法：</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; 1)</span><span style="font-family: 標楷體; font-size: 10pt;">空氣中的微生物。</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; 2)</span><span style="font-family: 標楷體; font-size: 10pt;">設施表面的微生物。</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; 3)</span><span style="font-family: 標楷體; font-size: 10pt;">人。</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; 4)</span><span style="font-family: 標楷體; font-size: 10pt;">水系統。</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; 5)</span><span style="font-family: 標楷體; font-size: 10pt;">原物料的負荷菌。</span> </p><p><span style="font-size: 10pt;">&nbsp; 2.</span><span style="font-family: 標楷體; font-size: 10pt;">酵母菌、黴菌及厭氣性微生物：</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">說明週期性或例行性管制方法及規格。</span> </p><p><span style="font-size: 10pt;">&nbsp; 3.</span><span style="font-family: 標楷體; font-size: 10pt;">超過限制範圍：</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">說明超過限制範圍時應採取的行動。</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">七、容器、封蓋與包裝的密封完整性</span> </p><p><span style="font-size: 10pt;">&nbsp; 1.</span><span style="font-family: 標楷體; font-size: 10pt;">摘要說明容器封蓋組合對防止微生物污染的密封性試驗方法與結果。說明內容初始</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">的確效試驗及安定性實驗計畫的試驗過程，僅提供產品的無菌試驗做為初始的確效</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">是不足的。</span> </p><p><span style="font-size: 10pt;">&nbsp; 2.</span><span style="font-family: 標楷體; font-size: 10pt;">規定密封完整性試驗方法的靈敏度。</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">八、細菌內毒素試驗方法</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">說明成品內毒素試驗方法，內容包括成品對內毒素的抑制或增強的試驗及結果，測</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">定無抑制時濃度及最大的有效稀釋倍數。</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">九、無菌試驗及放行規格</span> </p><p><span style="font-size: 10pt;">&nbsp; 1.</span><span style="font-family: 標楷體; font-size: 10pt;">說明無菌試驗的方法包括取樣的辦法。</span> </p><p><span style="font-size: 10pt;">&nbsp; 2.</span><span style="font-family: 標楷體; font-size: 10pt;">如果試驗方法與藥典方法有明顯差異時，應證明其相等性。</span> </p><p><span style="font-size: 10pt;">&nbsp; 3.</span><span style="font-family: 標楷體; font-size: 10pt;">說明在隔離系統內如何操作無菌試驗必要時得提供隔離系統的確效資料。</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">第</span> <span style="font-family: 標楷體; font-size: 10pt;">五</span> <span style="font-family: 標楷體; font-size: 10pt;">章</span><span style="font-size: 10pt;">&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">微生物管制與品質的維護</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">一、容器與封蓋組合的密封性</span> </p><p><span style="font-size: 10pt;">&nbsp; 1.</span><span style="font-family: 標楷體; font-size: 10pt;">測試在成品的有效期間或保存期限內、容器與封蓋的組合具有防止微生物污染保持</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">無菌品質的能力。</span> </p><p><span style="font-size: 10pt;">&nbsp; 2.</span><span style="font-family: 標楷體; font-size: 10pt;">請參考本手冊第二章五、及第四章七、，如同前面所述初始階段的無菌試驗不足以</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">證明容器封蓋組合密封性，同時也需要提供容器與封蓋組合的密封性測試方法的靈</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">敏度。</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">二、防腐劑的效果</span> </p><p><span style="font-size: 10pt;">&nbsp; 1.</span><span style="font-family: 標楷體; font-size: 10pt;">測試防腐劑的效果，可利用成品放行時規定的最低濃度或保存期限所規定的最低濃</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">度，二者取其較低者來測試。</span> </p><p><span style="font-size: 10pt;">&nbsp; 2.</span><span style="font-family: 標楷體; font-size: 10pt;">由於防腐劑的效果是以微生物被抑制的結果來判定所以必需以微生物的挑戰試驗來</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">測定。</span> </p><p><span style="font-size: 10pt;">&nbsp; 3.</span><span style="font-family: 標楷體; font-size: 10pt;">在安定性實驗計畫書內需規定，最初生產的三批成品必需在執行安定性試驗最初及</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">最終階段用微生物的挑戰試驗來測定防腐劑效果。</span> </p><p><span style="font-size: 10pt;">&nbsp; 4.</span><span style="font-family: 標楷體; font-size: 10pt;">可用化學檢驗方法測定安定性試驗期間內防腐劑的濃度。</span> </p><p><span style="font-size: 10pt;">&nbsp; 5.</span><span style="font-family: 標楷體; font-size: 10pt;">依據成品安定性實驗計畫書執行後續批次成品之安定性試驗時，該試驗中可用化學</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">方法來檢測防腐劑的濃度。</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">三、熱原或細菌內毒素試驗</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">無熱原的成品在安定性試驗計畫書中需實施安定性試驗的起始及最終階段之熱原或</span> </p><p><span style="font-size: 10pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 10pt;">內毒素試驗。</span> </p> 2013-12-05
1420540 臨床試驗類,藥品臨床試驗基準,銜接性試驗基準 行政解釋 銜接性試驗基準－接受國外臨床資料之族群因素考量 詳如附件 2013-12-05 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4552&type=0
1420541 罕見疾病類,罕見疾病藥物,衛生福利部受理罕見疾病藥物查驗登記審查費收費標準 行政解釋 衛生福利部受理罕病藥物查驗登記審查費收費標準 <p><span style="font-family: calibri;">&nbsp;</span></p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 104.5pt; padding-right: 5.4pt; padding-top: 0cm;border: windowtext 1pt solid;" valign="top"> <p><span style="font-family: 新細明體,serif;">受理類別</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 104.5pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">定義與範圍</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 104.55pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">收費基準</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 105.05pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">備註</span> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.5pt; padding-right: 5.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">新罕見疾病藥品</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.5pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">罕見疾病防治及藥物法規定之新藥</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.55pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">一○、○○○</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 105.05pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">新增項目</span> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.5pt; padding-right: 5.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;">&nbsp;</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.5pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">國內新設工廠、新劑型設立查核</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.55pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">四、○○○</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 105.05pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">新增項目</span> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.5pt; padding-right: 5.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;">&nbsp;</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.5pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">國外製藥工廠資料備查</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.55pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">四、○○○</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 105.05pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">新增項目</span> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.5pt; padding-right: 5.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">生物製劑、類毒素及菌液等基因工程製劑</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.5pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">血液製劑、抗毒素、疫苗、利用基因工程製造之藥品</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.55pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">一○、○○○</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 105.05pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">新增項目</span> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.5pt; padding-right: 5.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;">&nbsp;</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.5pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">國內新設工廠、新劑型設立查核</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.55pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">四、○○○</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 105.05pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">新增項目</span> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.5pt; padding-right: 5.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;">&nbsp;</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.5pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">國外製藥工廠資料備查</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.55pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">四、○○○</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 105.05pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">新增項目</span> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.5pt; padding-right: 5.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">臨床試驗</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.5pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">計畫書審核</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.55pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">三、○○○</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 105.05pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">新增項目</span> </p> </td> </tr> <tr style="height: 19.5pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 19.5pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">四</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">原料藥</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 19.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">供藥廠製造罕見疾病藥品之原料</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.25pt; padding-right: 1.4pt; height: 19.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">六、○○○</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 105.35pt; padding-right: 1.4pt; height: 19.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">新增項目</span> </p> </td> </tr> <tr style="height: 21.75pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 21.75pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">五</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">自用原料輸入</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 21.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">國內藥廠輸入自用之報備</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.25pt; padding-right: 1.4pt; height: 21.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">三○○</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 105.35pt; padding-right: 1.4pt; height: 21.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">新增項目</span> </p> </td> </tr> <tr style="height: 22.5pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 22.5pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">六</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">罕見疾病用之新醫療器材</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">含新醫療效能</span><span style="font-family: calibri;">)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 22.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">須檢附臨床、安全性試驗報告等之新醫療器材</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.25pt; padding-right: 1.4pt; height: 22.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">六、○○○</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 105.35pt; padding-right: 1.4pt; height: 22.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">新增項目</span> </p> </td> </tr> <tr style="height: 21.75pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 21.75pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;">&nbsp;</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 21.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">國內醫療器材廠</span><span style="font-family: calibri;"> GMP</span><span style="font-family: 新細明體,serif;">查核</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.25pt; padding-right: 1.4pt; height: 21.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">四、○○○</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 105.35pt; padding-right: 1.4pt; height: 21.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">新增項目</span> </p> </td> </tr> <tr style="height: 21.75pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 21.75pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;">&nbsp;</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 21.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">國外醫療器材工廠備查</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.25pt; padding-right: 1.4pt; height: 21.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">四、○○○</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 105.35pt; padding-right: 1.4pt; height: 21.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">新增項目</span> </p> </td> </tr> <tr style="height: 13.5pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 13.5pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">七</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">藥品變更</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 13.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">新適應症、新用法用量、新類別、新賦形劑</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.25pt; padding-right: 1.4pt; height: 13.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">二、四○○</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 105.35pt; padding-right: 1.4pt; height: 13.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">新增項目</span> </p> </td> </tr> <tr style="height: 20.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 20.25pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;">&nbsp;</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">委託製造、移轉、合併、產地變更、遷廠</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">以廠次計</span><span style="font-family: calibri;">)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.25pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">一、六○○</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 105.35pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">新增項目</span> </p> </td> </tr> <tr style="height: 20.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 20.25pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;">&nbsp;</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">其他變更或許可證、標仿單遺失補發</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.25pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">一、○○○</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 105.35pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">新增項目</span> </p> </td> </tr> <tr style="height: 20.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 20.25pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">八</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">醫療器材變更</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">增加新適用範圍</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.25pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">二、四○○</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 105.35pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">新增項目</span> </p> </td> </tr> <tr style="height: 20.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 20.25pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;">&nbsp;</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">委託製造、移轉、合併、產地變更、遷廠</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">以廠次計</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">、增加規格</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.25pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">一、六○○</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 105.35pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">新增項目</span> </p> </td> </tr> <tr style="height: 20.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 20.25pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;">&nbsp;</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">其他變更或許可證、標仿單遺失補發</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.25pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">一、○○○</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 105.35pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">新增項目</span> </p> </td> </tr> <tr style="height: 20.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 20.25pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">九</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">展延</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">原核准許可證、備查函有效期間展延</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.25pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">六○○</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 105.35pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">新增項目</span> </p> </td> </tr> <tr style="height: 20.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 20.25pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">十</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">產地證明、</span><span style="font-family: calibri;">GMP </span><span style="font-family: 新細明體,serif;">查廠、醫療器材英文證明</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">原核准許可證、備查函有效期間展延</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.25pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">三○○</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 105.35pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">新增項目</span> </p> </td> </tr> <tr style="height: 20.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 20.25pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">十一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">領證費用</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;">&nbsp;</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.25pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">三○○</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 105.35pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">新增項目</span> </p> </td> </tr> <tr> <td style="background-color: transparent; width: 139px;border-color: #f0f0f0;"></td> <td style="background-color: transparent; width: 139px;border-color: #f0f0f0;"></td> <td style="background-color: transparent; width: 139px;border-color: #f0f0f0;"></td> <td style="background-color: transparent;border-color: #f0f0f0;"></td> <td style="background-color: transparent; width: 140px;border-color: #f0f0f0;"></td> </tr> </tbody></table><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: calibri;">&nbsp;</span></p> 2013-12-05
1420542 臨床試驗類,藥品臨床試驗基準,癌症治療藥品臨床試驗基準 行政解釋 癌症治療藥品臨床試驗基準 詳如附件 2013-12-05 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4553&type=0
1420543 臨床試驗類,藥品臨床試驗報告之格式及內容基準 行政解釋 臨床試驗報告之格式及內容基準 詳如附件 2013-12-05 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4554&type=0
1420544 化學製造管制類,斷層掃描用正子放射同位素調製作業要點 行政解釋 斷層掃描用正子放射同位素調製作業要點 <p style="text-align: center;"><b><span style="font-family: 新細明體,serif; font-size: 14pt;">斷層掃描用正子放射同位素調製作業要點</span></b><b> </b></p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">壹</span><span style="font-size: 11pt;">&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">斷層掃描用正子放射同位素，係指半衰期很短之正子核種，例如氟</span><span style="font-size: 11pt;"> -</span></p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 18&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">半衰期為</span><span style="font-size: 11pt;"> 109.7&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">分鐘、碳</span><span style="font-size: 11pt;"> -11&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">半衰期為</span><span style="font-size: 11pt;"> 20.4 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">分鐘、氮</span><span style="font-size: 11pt;"> -13</span></p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">半衰期為</span><span style="font-size: 11pt;"> 9.96 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">分鐘、氧</span><span style="font-size: 11pt;"> -15&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">半衰期為</span><span style="font-size: 11pt;"> 2.03 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">分鐘，以合成方法調</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">製成正子放射同位素，供核子醫學專科醫師執行病人之正子斷層掃描</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">使用。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">貳</span><span style="font-size: 11pt;">&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">核子醫學專科醫師為特定病人正子斷層掃描之需要，得開立處方</span><span style="font-size: 11pt;"> (p-</span></p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; rescription)&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">交由藥局調製。藥局調製斷層掃描用正子放射同位素</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">，應由受過無菌操作訓練，及經行政院原子能委員會指定之游離輻射</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">防護訓練並領有輻射安全證書或執照之藥師，於符合原子能委員會所</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">規定之場所進行。藥局得於各該斷層掃描用正子放射同位素之有效期</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">限內，預先少量調製。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">參</span><span style="font-size: 11pt;">&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">藥局調製之斷層掃描用正子放射同位素，除供應該醫院之病人使用外</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">，並得供應其他醫院使用。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">肆</span><span style="font-size: 11pt;">&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">調製斷層掃描用正子放射同位素，應符合下列有關強度、品質及純度</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">之作業程序：</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">一</span><span style="font-size: 11pt;">&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">原物料</span><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">成分、材料、容器、封蓋、輔助品</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">的管制：</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">下列管制成分、材料及輔助品的項目需建立及執行，並且需有專人負</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">責監督：</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">一</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">書面規格的建立</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">每一成分</span><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">包括原料、試藥、靶液、氣體</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">的鑑別、純度及品質</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 2 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">會接觸到正子放射同位素的容器、封蓋及其它設備表層之材質</span><span style="font-size: 11pt;"> (</span></p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">包括輸送管線、純化裝置、過濾膜</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">的鑑別及品質。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 3 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">分析用的輔助品</span><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">如溶劑、層析管柱及對照標準品</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">、無菌試驗</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">用培養基、內毒素試藥及其它用於正子放射同位素品管步驟輔助</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</span><span style="font-family: 新細明體,serif; font-size: 11pt;">品的鑑別、純度及品質。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 4 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">用於調製正子放射同位素的成分、容器、封蓋、材料、輔助品的</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">適當儲存條件</span><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">如對熱、光、濕度之考慮</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">二</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">相關資料之登錄</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">記錄每批用於正子放射同位素調製之成分、容器、封蓋、材料、輔</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">助品的進貨、接收日期、數量、製造商、批號、有效期限等。如製</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">造商無標示有效期限，應基於其物理及化學特性及使用經驗來訂出</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">成分、材料、輔助品的有效期限。對於有可能裂解或組成改變的有</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">機受質、反應物、試劑材料，應依據該成分安定性的試驗結果來訂</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">定有效期限。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">三</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">原物料之檢驗</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">檢驗每批次使用於正子放射同位素調製的成分、容器及封蓋、材料</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">、輔助品是否符合所訂定的書面規格。上述檢驗，除鑑別試驗外，</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</span><span style="font-family: 新細明體,serif; font-size: 11pt;">得視供應商所提供檢驗報告之可靠性評估後，酌予減免。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">四</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">原物料之儲存</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">使用於正子放射同位素調製成分、容器及封蓋、材料及輔助品應依</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">據訂定的儲存條件存放於管制區。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">二</span><span style="font-size: 11pt;">&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">調製步驟的確認</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">需建立下列確認調製管制作業項目，且需由受過無菌操作訓練，及經</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">行政院原子能委員會指定之游離輻射防護訓練並領有輻射安全證書或</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif; font-size: 11pt;">執照之藥師來負責執行。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">一</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">正子放射同位素之鑑別、純度、品質應建立書面規格。如中華藥典</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">有收錄者以中華藥典為準。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">二</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">對於加入使用於正子放射同位素的針劑之無菌過濾膜</span><span style="font-size: 11pt;"> (0.22</span><span style="font-family: 新細明體,serif; font-size: 11pt;">&mu;</span><span style="font-size: 11pt;">m)</span></p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">及加入使用於正子放射同位素的吸入劑劑型之粒子過濾膜</span><span style="font-size: 11pt;"> (0.45</span><span style="font-family: 新細明體,serif; font-size: 11pt;">&mu;</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; m)</span><span style="font-family: 新細明體,serif; font-size: 11pt;">，必需有書面及確效步驟，調製步驟必需經常更新及確認，或至</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">少每年檢視或確認以確保其為現行使用的調製步驟。正子放射同位</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">素的書面調製步驟總檔案需存於正子放射同位素調製中心內。為了</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">供作參考，過期的書面調製步驟檔案也需與現行調製版本之總檔案</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">分開存於正子放射同位素調製中心內。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">三</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">只有被授權的人可以更改電腦及相關自動化裝置之調製軟體。任何</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">上述的改變必須記錄存檔及加以確認，只有現行版本軟體可使用於</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">正子放射同位素調製步驟。使用於正子放射同位素調製之軟體碟片</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">及書面資料需存於正子放射同位素調製中心的總檔案內。為了供作</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">參考，過期電腦軟體也需與總檔案分開儲存。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">四</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">驗證所制定之調製步驟、電腦軟體程式、設備及設施等能調製出符</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">合規格的正子放射同位素。如果中華藥典有收錄者，則所調製之正</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">子放射同位素的純度及品質，必須符合中華藥典之基準規範。如果</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</span><span style="font-family: 新細明體,serif; font-size: 11pt;">所調製的正子放射同位素未列於中華藥典，則此驗證須包括：</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 1 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">書面評估放射化學的鑑別及純度、放射核種的鑑別及純度、特異</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">活性、無菌性</span><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">針劑製劑</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">、細菌內毒素含量</span><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">針劑製劑</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">、酸</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">鹼度、外觀、立體化學純度</span><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">用於適用的化合物</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">、可能存在的</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">有機揮發性不純物、在合成或是純化過程中會使用到之其他有毒</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">化學物質、安定劑或保藏劑的有效濃度</span><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">如果有加入安定劑或保</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">藏劑</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">、正子放射同位素的化學純度</span><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">包括分析起始物質、已知</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">中間產物、副產物及已知分解產物</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">及開始與最終亞次批</span><span style="font-size: 11pt;"> (sub-</span></p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; batch)</span><span style="font-family: 新細明體,serif; font-size: 11pt;">下產物的均質性</span><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">指正子放射同位素之放射性核種半衰期</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &lt; 25&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">分鐘</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">。「亞批」</span><span style="font-size: 11pt;">(sub-batch) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">的定義為正子放射同位素</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">在特定的範圍內具有一致的特性及品質，使用在連續的多次照射</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">中所產生的放射核種，並經由一定的合成及／或純化作業所調製</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">而成。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 2 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">由操作者簽章及註記日期，保留紀錄，以證明其調製正子放射同</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">位素步驟、設備及設施符合既定之標準。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">五</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">任何調製過程、電腦軟體程式、成分規格上的改變，而可能會影響</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">到產品的鑑別、品質或純度時，則驗證程序必須予以執行。供人使</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">用的正子放射同位素，在其新的或更新過的調製程序獲得許可之前</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">，應對連續三批產品進行驗證程序，並確保此產品符合規格。只要</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">例行性的驗證結果均能符合規定，則可改為每年至少執行一次。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">三</span><span style="font-size: 11pt;">&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">安定性試驗及有效期限</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">一</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">正子放射同位素之有效期限及儲存條件的書面訂定，應根據安定性</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">試驗及特異活性的結果為基礎。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;(</span><span style="font-family: 新細明體,serif; font-size: 11pt;">二</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">進行安定性試驗的檢體應取自規定的密閉容器。正子放射同位素必</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">須在末效期仍符合所有規格。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">三</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">如果調製步驟過程、電腦軟體程式、成分規格的改變可能會影響到</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">產品的安定性，則其安定性試驗必須再評估。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">四</span><span style="font-size: 11pt;">&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">調製供人使用的正子放射同位素</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">所有的調製行為應確實地由合格及受過訓練的人員來執行及完成。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">根據已建立的書面程序及文件完成下列要求：</span> </p><p><span style="font-size: 11pt;">&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(</span><span style="font-family: 新細明體,serif; font-size: 11pt;">一</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">在開始調製前，應將不必要的材料及標籤自該場所設備中移除，並</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">檢視場所及所有設備的清淨度及適用性。對於注射用的正子放射同</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">位素，所有使用於無菌薄膜過濾的成分、容器、封蓋及其它材料的</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">操作過程，均必須在適當控制的環境下採用無菌操作技術進行之。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">二</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">確認各成分、容器、封蓋及用於調製正子放射同位素的其它物料的</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">特性、數量及適用性。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(</span><span style="font-family: 新細明體,serif; font-size: 11pt;">三</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">調劑步驟中使用的所有成分應予以標示，以便確認及追溯之用。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">四</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">在開始調製步驟前，標示最終正子放射同位素的容器或用於調劑給</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">藥的裝置。附在最終容器上的標籤或貼紙必須具備下列資料：正子</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">放射同位素的名稱及添加物</span><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">如：安定劑及保藏劑的名稱</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">、批號</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">、放射活性校正日期及時間、校正時每</span><span style="font-size: 11pt;">mL</span><span style="font-family: 新細明體,serif; font-size: 11pt;">的放射活性量、放射性物</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">質標誌及警語，並標示「溶液如有混濁或含顆粒物時，請勿使用」</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">。最終的正子放射同位素應同時標示包括總放射活性、在指定的校</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">正時間之放射活性濃度及有效時間與日期。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">五</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">根據現行經過驗證的步驟來調製正子放射同位素，必須保留每一批</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">調製正子放射同位素的書面紀錄</span><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">如：在一次合成及純化過程中所</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">調製出的產品</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">。此書面紀錄包括：</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 1 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">批號、製造廠名稱、有效日期，所有成分、容器、封蓋以及用於</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">調製步驟中使用材料的數量。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 2 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">每一個調製步驟說明。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 3 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">負責人簽章，證明此批產品的調製步驟正確且經過確認。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 4 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">負責人必須經由目視</span><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">應考慮視力及輻射暴露的限制</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">，或經由</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">電腦或其它回饋機轉加以監控，證明在調製過程中關鍵步驟均已</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">完成。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 5 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">對調製過程中非計畫性的偏差，或非預期性結果，應包括調查結</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">果書面記錄。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 6 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">放射同位素的產率是利用同位素放射性核種之原始核種經過衰變</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">修正後的放射活度來計算。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 7 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">每一批正子放射同位素之原始分析資料。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 8 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">調製程序完成後，應由負責操作者簽章及註記日期。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">五</span><span style="font-size: 11pt;">&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">品質管制</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">指定經過訓練、合格的人員負責確保品質管制過程是由受過訓練的合</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">格人員來執行及確實完成。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">根據既定之書面程序完成下列事項並加以記錄。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">一</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">以書面方式建立每一批正子放射同位素的品質管制試驗、分析步驟</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">及規格。如中華藥典有收錄者以中華藥典為準。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 1 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">具半衰期≧</span><span style="font-size: 11pt;">25.0&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">分鐘核種的正子放射同位素，每一批同位素</span><span style="font-size: 11pt;"> (</span></p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">一次的合成及純化操作所產生的物質</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">在放行前，必須完成下列</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">品質管制檢驗：口服及注射劑型之同位素，須作酸鹼值量測及目</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">視檢查；所有劑型均須作放射化學鑑別與純度測定及放射核種鑑</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">別定及純度測定；基於與同位素有關的分佈或毒性反應的考量，</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">應評估正子放射同位素的特異活性；及在合成或純化過程中所使</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">用或產生之其他毒性物質與殘餘溶劑與安定劑或保藏劑，應證明</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</span><span style="font-family: 新細明體,serif; font-size: 11pt;">符合所定之基準內；測定正子放射同位素的放射活性。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 2 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">核種具半衰期</span><span style="font-size: 11pt;"> &lt; 25.0 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">分鐘之正子放射同位素，其「一批」定義</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">為一天中所調製之正子放射同位素之所有相關亞批，在當天第一</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">亞批正子放射同位素之品質管制必須完成下列檢驗：口服及注射</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">劑之同位素，須作酸鹼值量測及目視檢查；所有劑型均須作放射</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">化學鑑別與純度測定及放射核種鑑別與純度測定；基於與同位素</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">有關之分佈或毒性考量，正子放射同位素特異活性應作評估；及</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">在合成或純化過程中所使用或產生之其它毒性物質與殘餘溶劑，</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">與安定劑或保藏劑應證明符合所訂定之基準內；測定正子放射同</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">位素的放射活性。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 3 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">每批供注射用的正子放射同位素</span><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">除了氧</span><span style="font-size: 11pt;"> -15&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">水之外</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">，須在</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">同位素過濾完成後，完成過濾膜完整性試驗，方可放行供人體使</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">用。供注射用的氧</span><span style="font-size: 11pt;"> -15&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">水，可在過濾膜完整性試驗完成前先放</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">行，但必須在放行後儘快完成上述試驗。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 4 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">供注射用之正子放射同位素，核種半衰期≧</span><span style="font-size: 11pt;">25.0&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">分鐘者，在放</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">行供人體使用前須完成</span><span style="font-size: 11pt;"> 20 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">分鐘內毒素</span><span style="font-size: 11pt;"> "</span><span style="font-family: 新細明體,serif; font-size: 11pt;">限量試驗</span><span style="font-size: 11pt;">"&nbsp; (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">加入陽性</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">標準品，其濃度由</span><span style="font-size: 11pt;"> 5 EU/mL&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">至</span><span style="font-size: 11pt;"> 175 EU/V</span><span style="font-family: 新細明體,serif; font-size: 11pt;">，</span><span style="font-size: 11pt;">V&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">是在有效期限時</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">產品之最大體積，以</span><span style="font-size: 11pt;"> mL </span><span style="font-family: 新細明體,serif; font-size: 11pt;">表示</span><span style="font-size: 11pt;">)</span><span style="font-family: 新細明體,serif; font-size: 11pt;">；核種半衰期</span><span style="font-size: 11pt;">&lt; 25.0 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">分鐘者，應</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">於當天第一亞批品質管制檢驗時完成</span><span style="font-size: 11pt;"> 20 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">分鐘內毒素</span><span style="font-size: 11pt;"> "</span><span style="font-family: 新細明體,serif; font-size: 11pt;">限量試驗</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; " </span><span style="font-family: 新細明體,serif; font-size: 11pt;">，方可放行供人體使用。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 5 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">供注射用之正子放射同位素，核種半衰期≧</span><span style="font-size: 11pt;">25.0&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">分鐘者，須逐</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">批執行標準</span><span style="font-size: 11pt;"> 60 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">分鐘之細菌內毒素試驗；核種半衰期</span><span style="font-size: 11pt;">&lt; 25.0&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">分</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</span><span style="font-family: 新細明體,serif; font-size: 11pt;">鐘者，應於當天第一亞批品質管制檢驗時執行標準</span><span style="font-size: 11pt;"> 60 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">分鐘之細</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">菌內毒素試驗。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 6 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">供注射用之正子放射同位素，核種半衰期≧</span><span style="font-size: 11pt;">25.0&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">分鐘者，須逐</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">批執行無菌試驗；核種半衰期</span><span style="font-size: 11pt;">&lt; 25.0</span><span style="font-family: 新細明體,serif; font-size: 11pt;">分鐘者，應於當天第一亞批</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">品質管制檢驗時執行無菌試驗。本品可在無菌檢查完成前放行使</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">用，惟須在同位素過濾後</span><span style="font-size: 11pt;"> 24-72&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">小時內開始執行。受測產品須</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">個別測試，不得混合許多產品樣本試驗。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">二</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">供人使用各批之正子放射同位素，應設立書面程序來實行品質管制</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">試驗。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">三</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">驗證測試正子放射同位素品質試驗之程序及儀器。分析儀器</span><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">如氣</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">相層析或液相層析</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">須在開始安裝或重要維修後，以內或外標準品</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">來實施校正操作。該校正工作必需根據適當的書面程序定期執行</span><span style="font-size: 11pt;"> (</span></p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">如：系統適合性試驗必須執行</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">四</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">必須依據書面程序來執行各批正子放射同位素品質管制試驗，並簽</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">章該試驗的結果。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">五</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">依據品質管制試驗結果是否符合規格，來判定准用或拒用該批正子</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">放射同位素。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">如該批正子放射同位素准用，則必須在品質管制紀錄上簽章及加註</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">日期。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">六</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">任何一批不通過品質管制試驗的正子放射同位素，必須調查不合格</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">的原因，並將調查結果建檔。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">六</span><span style="font-size: 11pt;">&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">滅菌及無菌確效</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">需確認正子放射同位素的無菌性，建立、作成書面紀錄並確實執行下</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">列各無菌操作：</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">一</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">調製同位素的儀器及組成</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">調製正子放射同位素的器材必需經過適當地清洗，並保持清潔狀態</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">。接觸正子放射同位素溶液的器材，可設法去除內毒素及滅菌處理</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">來除去微生物。該器材須存放於清潔或無菌的環境下。與正子放射</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">同位素生產有關的物質，宜由已通過無菌藥品規格鑑定的合格廠商</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">來獲得，無菌瓶、注射針、轉移組</span><span style="font-size: 11pt;"> (transfer set) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">及過濾膜也建</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">議採用合格市售品。如該等器材由調製單位自行滅菌，則必須確認</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">滅菌過程及裝配組件的無菌性，並且定期確認其滅菌效能。注射用</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</span><span style="font-family: 新細明體,serif; font-size: 11pt;">溶液必須用過濾膜除菌，並以無菌操作移至一無菌、無熱原及多劑</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">量的瓶中。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">二</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">環境控制</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">供調製最終產品的工作區域必須清潔。無菌層流操作台</span><span style="font-size: 11pt;"> (aseptic</span></p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; hood) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">應放置於人員進出需受管制的區域中，並防止微生物污染。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">在使用無菌層流操作台時，需穿上清潔之實驗衣。成分、物料及儀</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">器移入無菌區需以容器盛裝或包裹之。供作最終產品之容器、過濾</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">套組、透氣的過濾膜及注射針頭均必須是無菌、可拋棄式及僅供單</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">次使用。過濾膜組裝在產品收集瓶中後，仍必須保持該組裝套組的</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">無菌狀態。如任何套組的無菌性受損，則該套組必須更換。在插入</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">最終產品容器前，該瓶子的瓶口橡皮塞必須用</span><span style="font-size: 11pt;"> 70 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">％乙醇或異丙醇</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">等消毒劑擦拭，並讓其在無菌層流操作台中自然揮發。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">三</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">無菌層流操作台</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">調製最終產品的過濾膜與容器應於無菌層流操作台內組裝。無菌操</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">作必須於</span><span style="font-size: 11pt;"> 100&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">級之無菌工作區進行</span><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">如：層流操作台或隔離箱</span><span style="font-size: 11pt;">)</span></p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">。操作台表面及儀器表面須容易清潔及消毒。消毒劑須過濾或具有</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">廠商的無菌證明書。在每天使用前及新儀器移入無菌層流操作台後</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">，必須清潔及消毒操作台內部表面。針對無菌層流操作台的環境，</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">須定期執行微生物試驗</span><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">如：每週</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">，可由擦拭棒、接觸培養皿、</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">落菌試驗用培養皿或空氣採樣器等方法執行，懸浮於空氣中的非活</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">性粒子計數，則可以間隔較長的時間檢查。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">四</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">無菌技術</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 1 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">所有無菌操作，包括組裝無菌組件、調製、過濾與處理無菌溶液</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">，都必須經由合格者去執行。覆蓋及開啟無菌物品的防護密封時</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">，必須在無菌層流操作台內操作。任何無菌設備或組件接觸到非</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">無菌表面時，必須重新更換。無菌組件移出無菌層流操作台前應</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">置於密封容器內。操作者必須穿上清潔之實驗衣來執行無菌操作</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">過程。操作者手部伸入無菌層流操作台之前，應戴上手套並經消</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">毒。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 2 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">無菌區的操作應由通過微生物測驗及定期觀察者來執行。操作者</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">使用於製造無菌產品的無菌操作技術，是以模擬測試來評估，即</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">利用微生物的生長之培養基來取代正子放射同位素溶液，檢視連</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">接出氣口及過濾的操作過程，如出口處連接之操作及過濾。確認</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">正子放射同位素容器內培養基的效能試驗是程序模擬測試的一個</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">關鍵控制。模擬程序結束後，最終產品其容器應稍加搖動震盪，</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">直到培養基接觸到容器內部所有表面，容器和培養基應培養於</span><span style="font-size: 11pt;"> 3</span></p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 0 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">～</span><span style="font-size: 11pt;">35</span><span style="font-family: 新細明體,serif; font-size: 11pt;">℃、</span><span style="font-size: 11pt;">20</span><span style="font-family: 新細明體,serif; font-size: 11pt;">～</span><span style="font-size: 11pt;">25</span><span style="font-family: 新細明體,serif; font-size: 11pt;">℃或其他適當溫度達</span><span style="font-size: 11pt;"> 14 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">天以上，期間應每隔</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">一段時間檢查是否有微生物生長。通過測試的結果必須是容器內</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">沒有微生物生長。一個新的操作者，須執行及通過模擬測試三次</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">，方可被認可為合格操作者。每位合格操作者須每年通過模擬測</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">試，有任何操作步驟變更時，則操作者必須通過該變更步驟的模</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;</span><span style="font-family: 新細明體,serif; font-size: 11pt;">擬測試。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">五</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">過濾過程的驗證</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 1 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">無菌過濾是正子放射同位素溶液中移去微生物最後關鍵的防護措</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">施，這個重要步驟必須能夠證實在特定狀況下能利用過濾膜來阻</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">擋微生物。製造及消毒過濾器的廠商，一般會提供過濾條件</span><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">如</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">壓力和流量</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">。當過濾正子放射同位素時，切勿超過上述的過濾</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">條件。對酸鹼值近乎中性的大部分水溶液，有關過濾器阻擋微生</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">物能力的證明可從過濾器廠商獲得。驗證每批過濾器符合規格的</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">書面證明必須查證及存檔。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 2 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">在使用某一批過濾器前，使用者必須任選一個過濾器來測試其完</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">整性，以證實過濾器及外殼並無失去保留微生物的能力。廠商應</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">提供完整性測試的方法，或者使用經過確效的其它方法。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 3 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">在正子放射同位素過濾後，應以</span><span style="font-size: 11pt;"> "</span><span style="font-family: 新細明體,serif; font-size: 11pt;">起泡點</span><span style="font-size: 11pt;">(Bubble Point)" </span><span style="font-family: 新細明體,serif; font-size: 11pt;">測試</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">等方法檢視無菌過濾膜的完整性後始得放行。</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">六</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">最終產品的微生物測試</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">供注射用之正子放射同位素，必須是無菌且不含內毒素，這兩項可</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">用無菌試驗及細菌內毒素試驗加以證明。細菌內毒素試驗是必須在</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">調製之後立即執行；而無菌試驗，可以在調製後</span><span style="font-size: 11pt;"> 24-72&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">小時內執</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">行。每批同位素必須個別測試，且不可混合數個批次的同位素後再</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">做微生物測試。若微生物檢驗不通過，必須調查其原因並加以修正</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">。如果記錄顯示連續成功地通過無菌試驗，則僅有每天首批配製的</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">正子放射同位素必須進行無菌試驗。然而當調製不同正子放射同位</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">素時或更換新無菌器材</span><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">如過濾器或最終產品容器</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">，則必須測試</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">每批正子放射同位素之無菌性，直到建立連續成功通過測試紀錄，</span> </p><p><span style="font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; font-size: 11pt;">方可僅測試每天首批同位素的無菌性。</span> </p> 2013-12-05
1420545 臨床試驗類,醫療法 法律 醫療法 <p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">為促進醫療事業之健全發展，合理分布醫療資源，提高醫療品質，保障病人權益，增進國民健康，特制定本法。本法未規定者，適用其他法律規定。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本法所稱醫療機構，係指供醫師執行醫療業務之機構。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 3 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本法所稱公立醫療機構，係指由政府機關、公營事業機構或公立學校所設立之醫療機構。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 4 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本法所稱私立醫療機構，係指由醫師設立之醫療機構。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 5 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本法所稱醫療法人，包括醫療財團法人及醫療社團法人。</span> </p><p><span style="font-family: 新細明體,serif;">本法所稱醫療財團法人，係指以從事醫療事業辦理醫療機構為目的，由捐助人捐助一定財產，經中央主管機關許可並向法院登記之財團法人。</span> </p><p><span style="font-family: 新細明體,serif;">本法所稱醫療社團法人，係指以從事醫療事業辦理醫療機構為目的，經中央主管機關許可登記之社團法人。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 6 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本法所稱法人附設醫療機構，係指下列醫療機構：</span> </p><p><span style="font-family: 新細明體,serif;">一、私立醫學院、校為學生臨床教學需要附設之醫院。</span> </p><p><span style="font-family: 新細明體,serif;">二、公益法人依有關法律規定辦理醫療業務所設之醫療機構。</span> </p><p><span style="font-family: 新細明體,serif;">三、其他依法律規定，應對其員工或成員提供醫療衛生服務或緊急醫療救護之事業單位、學校或機構所附設之醫務室。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 7 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本法所稱教學醫院，係指其教學、研究、訓練設施，經依本法評鑑可供醫師或其他醫事人員之訓練及醫學院、校學生臨床見習、實習之醫療機構。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 8 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本法所稱人體試驗，係指醫療機構依醫學理論於人體施行新醫療技術、新藥品、新醫療器材及學名藥生體可用率、生體相等性之試驗研究。</span> </p><p><span style="font-family: 新細明體,serif;">人體試驗之施行應尊重接受試驗者之自主意願，並保障其健康權益與隱私權。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 9 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本法所稱醫療廣告，係指利用傳播媒體或其他方法，宣傳醫療業務，以達招徠患者醫療為目的之行為。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 10 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本法所稱醫事人員，係指領有中央主管機關核發之醫師、藥師、護理師、物理治療師、職能治療師、醫事檢驗師、醫事放射師、營養師、藥劑生、護士、助產士、物理治療生、職能治療生、醫事檢驗生、醫事放射士及其他醫事專門職業證書之人員。</span> </p><p><span style="font-family: 新細明體,serif;">本法所稱醫師，係指醫師法所稱之醫師、中醫師及牙醫師。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 11 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本法所稱主管機關：在中央為行政院衛生署；在直轄市為直轄市政府；在縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">為縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">政府。</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">二</span> <span style="font-family: 新細明體,serif;">章</span> <span style="font-family: 新細明體,serif;">醫療機構</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 12 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療機構設有病房收治病人者為醫院，僅應門診者為診所；非以直接診治病人為目的而辦理醫療業務之機構為其他醫療機構。</span> </p><p><span style="font-family: 新細明體,serif;">前項診所得設置九張以下之觀察病床；婦產科診所，得依醫療業務需要設置十張以下產科病床。</span> </p><p><span style="font-family: 新細明體,serif;">醫療機構之類別與各類醫療機構應設置之服務設施、人員及診療科別設置條件等之設置標準，由中央主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 13 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">二家以上診所得於同一場所設置為聯合診所，使用共同設施，分別執行門診業務；其管理辦法，由中央衛生主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 14 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫院之設立或擴充，應經主管機關許可後，始得依建築法有關規定申請建築執照；其設立分院者，亦同。</span> </p><p><span style="font-family: 新細明體,serif;">前項醫院設立或擴充之許可，其申請人之資格、審查程序及基準、限制條件、撤銷、廢止及其他應遵行事項之辦法，由中央主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 15 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療機構之開業，應向所在地直轄市、縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">主管機關申請核准登記，經發給開業執照，始得為之；其登記事項如有變更，應於事實發生之日起三十日內辦理變更登記。</span> </p><p><span style="font-family: 新細明體,serif;">前項開業申請，其申請人之資格、申請程序、應檢具文件及其他應遵行之事項，由中央主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 16 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">私立醫療機構達中央主管機關公告一定規模以上者，應改以醫療法人型態設立。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 17 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療機構名稱之使用、變更，應以所在地直轄市、縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">主管機關核准者為限；其名稱使用、變更原則，由中央主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">非醫療機構，不得使用醫療機構或類似醫療機構之名稱。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 18 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療機構應置負責醫師一人，對其機構醫療業務，負督導責任。私立醫療機構，並以其申請人為負責醫師。</span> </p><p><span style="font-family: 新細明體,serif;">前項負責醫師，以在中央主管機關指定之醫院、診所接受二年以上之醫師訓練並取得證明文件者為限。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 19 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">負責醫師因故不能執行業務，應指定合於負責醫師資格之醫師代理。代理期間超過四十五日者，應由被代理醫師報請原發開業執照機關備查。</span> </p><p><span style="font-family: 新細明體,serif;">前項代理期間，不得逾一年。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 20 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療機構應將其開業執照、診療時間及其他有關診療事項揭示於明顯</span><span style="font-family: calibri;">&nbsp; </span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">處所。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 21 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療機構收取醫療費用之標準，由直轄市、縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">主管機關核定</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 22 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療機構收取醫療費用，應開給載明收費項目及金額之收據。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">醫療機構不得違反收費標準，超額或擅立收費項目收費。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 23 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療機構歇業、停業時，應於事實發生後三十日內，報請原發開業執</span><span style="font-family: calibri;">&nbsp; </span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">照機關備查。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">前項停業之期間，以一年為限；逾一年者，應於屆至日起三十日內辦</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">理歇業。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">醫療機構未依前項規定辦理歇業時，主管機關得逕予歇業。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">醫療機構遷移者，準用關於設立及開業之規定。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">醫療機構復業時，準用關於開業之規定。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 24 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療機構應保持環境整潔、秩序安寧，不得妨礙公共衛生及安全。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">為保障病人就醫安全，任何人不得以強暴、脅迫、恐嚇或其他非法之</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">方法，滋擾醫療機構秩序或妨礙醫療業務之執行。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">違反前項規定者，警察機關應協助排除或制止之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 25 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫院除其建築構造、設備應具備防火、避難等必要之設施外，並應建</span><span style="font-family: calibri;">&nbsp; </span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">立緊急災害應變措施。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">前項緊急災害應變措施及檢查辦法，由中央主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 26 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療機構應依法令規定或依主管機關之通知，提出報告，並接受主管</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">機關對其人員配置、設備、醫療收費、醫療作業、衛生安全、診療紀</span><span style="font-family: calibri;">&nbsp; </span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">錄等之檢查及資料蒐集。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 27 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">於重大災害發生時，醫療機構應遵從主管機關指揮、派遣，提供醫療</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">服務及協助辦理公共衛生，不得規避、妨礙或拒絕。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">醫療機構依前項規定提供服務或協助所生之費用或損失，主管機關應</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">酌予補償。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 28 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">中央主管機關應辦理醫院評鑑。直轄市、縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">主管機關對轄區內</span><span style="font-family: calibri;">&nbsp; </span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">醫療機構業務，應定期實施督導考核。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 29 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">公立醫院得邀請當地社會人士組成營運諮詢委員會，就加強地區醫療</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">服務，提供意見。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">公立醫院應提撥年度醫療收入扣除費用後餘額之百分之十以上，辦理</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">有關研究發展、人才培訓、健康教育、醫療救濟、社區醫療服務及其</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">他社會服務事項。</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">三</span> <span style="font-family: 新細明體,serif;">章</span> <span style="font-family: 新細明體,serif;">醫療法人</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">一</span> <span style="font-family: 新細明體,serif;">節</span> <span style="font-family: 新細明體,serif;">通則</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 30 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療財團法人之設立、組織及管理，依本法之規定；本法未規定者，</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">依民法之規定。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">醫療社團法人，非依本法規定，不得設立；其組織、管理、與董事間</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">之權利義務、破產、解散及清算，本法未規定者，準用民法之規定。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 31 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療法人得設立醫院、診所及其他醫療機構。其設立之家數及規模，</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">得為必要之限制。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">前項設立家數及規模之限制，由中央主管機關定之。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">醫療法人經中央主管機關及目的事業主管機關之許可，得附設下列機</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">構：</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">一、護理機構、精神復健機構。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">二、關於醫學研究之機構。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">三、老人福利法等社會福利法規規定之相關福利機構。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">前項附設機構之設立條件、程序及其他相關事項，仍依各該相關法規</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">之規定辦理。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 32 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療法人應有足以達成其設立目的所必要之財產。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">前項所稱必要之財產，依其設立之規模與運用條件，由中央主管機關</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 33 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療法人，應設董事會，置董事長一人，並以董事長為法人之代表人。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">醫療法人，對於董事會與監察人之組織與職權、董事、董事長與監察</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</span><span style="font-family: 新細明體,serif;">人之遴選資格、選聘與解聘程序、會議召開與決議程序及其他有關事</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">項等，應訂立章則，報請中央主管機關核准。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 34 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療法人應建立會計制度，採曆年制及權責發生制，其財務收支具合</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">法憑證，設置必要之會計紀錄，符合公認之會計處理準則，並應保存</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">之。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">醫療法人應於年度終了五個月內，向中央主管機關申報經董事會通過</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">及監察人承認之年度財務報告。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">前項財務報告編製準則，由中央主管機關定之。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">醫療社團法人除適用前述規定外；其會計制度，並應依公司法相關規</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">定辦理。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">中央主管機關得隨時命令醫療法人提出財務、業務報告或檢查其財</span><span style="font-family: calibri;">&nbsp; </span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">務、業務狀況。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">醫療法人對於前項之命令或檢查，不得規避、妨礙或拒絕。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 35 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療法人不得為公司之無限責任股東或合夥事業之合夥人；如為公司</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">之有限責任股東時，其所有投資總額及對單一公司之投資額或其比例</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">應不得超過一定之限制。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">前項投資限制，由中央主管機關定之。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">醫療法人因接受被投資公司以盈餘或公積增資配股所得之股份，不計</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">入前項投資總額或投資額。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 36 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療法人財產之使用，應受中央主管機關之監督，並應以法人名義登</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">記或儲存；非經中央主管機關核准，不得對其不動產為處分、出租、</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">出借、設定負擔、變更用途或對其設備為設定負擔。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 37 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療法人不得為保證人。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;</span><span style="font-family: 新細明體,serif;">醫療法人之資金，不得貸與董事、社員及其他個人或非金融機構；亦</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">不得以其資產為董事、社員或任何他人提供擔保。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 38 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">私人及團體對於醫療財團法人之捐贈，得依有關稅法之規定減免稅</span><span style="font-family: calibri;">&nbsp; </span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">賦。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">醫療財團法人所得稅、土地稅及房屋稅之減免，依有關稅法之規定辦</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">理。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">本法修正施行前已設立之私立醫療機構，於本法修正施行後三年內改</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">設為醫療法人，將原供醫療使用之土地無償移轉該醫療法人續作原來</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">之使用者，不課徵土地增值稅。但於再次移轉第三人時，以該土地無</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">償移轉前之原規定地價或前次移轉現值為原地價，計算漲價總數額，</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">課徵土地增值稅。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 39 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療法人經中央主管機關許可，得與其他同質性醫療法人合併之。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">醫療法人經中央主管機關許可合併後，應於兩週內作成財產目錄及資</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">產負債表，並通知債權人。公司法第七十三條第二項、第七十四條第</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">一項之規定準用之。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">因合併而消滅之醫療法人，其權利義務由合併後存續或另立之醫療法</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">人概括承受。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 40 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">非醫療法人，不得使用醫療法人或類似之名稱。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 41 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療法人辦理不善、違反法令或設立許可條件者，中央主管機關得視</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">其情節予以糾正、限期整頓改善、停止其全部或一部之門診或住院業</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">務、命其停業或廢止其許可。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">醫療法人因其自有資產之減少或因其設立之機構歇業、變更或被廢止</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">許可，致未符合中央主管機關依第三十二條第二項所為之規定，中央</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">主管機關得限期令其改善；逾期未改善者，得廢止其許可。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">醫療法人有下列情事之一者，中央主管機關得廢止其許可：</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">一、經核准停業，逾期限尚未辦理復業。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">二、命停止全部或一部門診或住院業務，而未停止。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">三、命停業而未停業或逾停業期限仍未整頓改善。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">四、受廢止開業執照處分。</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">二</span> <span style="font-family: 新細明體,serif;">節</span> <span style="font-family: 新細明體,serif;">醫療財團法人</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 42 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療財團法人之設立，應檢具捐助章程、設立計畫書及相關文件，申</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">請中央主管機關許可。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">前項醫療財團法人經許可後，捐助人或遺囑執行人應於三十日內依捐</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">助章程遴聘董事，成立董事會，並將董事名冊於董事會成立之日起三</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">十日內，報請中央主管機關核定，並於核定後三十日內向該管地方法</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">院辦理法人登記。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">捐助人或遺囑執行人，應於醫療財團法人完成法人登記之日起三個月</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">內，將所捐助之全部財產移歸法人所有，並報請中央主管機關備查。</span><span style="font-family: calibri;">&nbsp; </span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">捐助人或遺囑執行人未於期限內將捐助財產移歸法人所有，經限期令</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">其完成，逾期仍未完成者，中央主管機關得廢止其許可。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 43 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療財團法人之董事，以九人至十五人為限；其中三分之一以上應具</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">醫師及其他醫事人員資格。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">外國人充任董事，其人數不得超過總名額三分之一；董事相互間，有</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">配偶及三親等以內血親、姻親關係者，亦同。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">董事會開會時，董事應親自出席，不得委託他人代理。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 44 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療財團法人捐助章程之變更，應報經中央主管機關許可。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">醫療財團法人董事長、董事、財產或其他登記事項如有變更，應依中</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">央主管機關之規定報請許可。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">前二項之變更，應於中央主管機關許可後三十日內，向該管法院辦理</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">變更登記。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 45 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療財團法人之董事，任期屆滿未能改選或出缺未能補任，顯然妨礙</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">董事會組織健全之虞者，中央主管機關得依其他董事、利害關係人之</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">申請或依職權，選任董事充任之；其選任辦法，由中央主管機關定之。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">醫療財團法人之董事違反法令或章程，有損害該法人或其設立機構之</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">利益或致其不能正常營運之虞者，中央主管機關得依其他董事或利害</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">關係人之聲請或依職權，命令該董事暫停行使職權或解任之。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">前項董事之暫停行使職權，期間不得超過六個月。於暫停行使職權之</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">期間內，因人數不足顯然妨礙董事會組織健全之虞者，中央主管機關</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">應選任臨時董事暫代之。選任臨時董事毋需變更登記；其選任，準用</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">第一項選任辦法之規定。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 46 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療財團法人應提撥年度醫療收入結餘之百分之十以上，辦理有關研究發展、人才培訓、健康教育；百分之十以上辦理醫療救濟、社區醫療服務及其他社會服務事項；辦理績效卓著者，由中央主管機關獎勵之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">三</span> <span style="font-family: 新細明體,serif;">節</span> <span style="font-family: 新細明體,serif;">醫療社團法人</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 47 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療社團法人之設立，應檢具組織章程、設立計畫書及相關文件，申請中央主管機關許可。</span> </p><p><span style="font-family: 新細明體,serif;">前項醫療社團法人經許可後，應於三十日內依其組織章程成立董事會，並於董事會成立之日起三十日內，報請中央主管機關登記，發給法人登記證書。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 48 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療社團法人設立時，應登記之事項如下：</span> </p><p><span style="font-family: 新細明體,serif;">一、法人設立目的及名稱。</span> </p><p><span style="font-family: 新細明體,serif;">二、主事務所及分事務所。</span> </p><p><span style="font-family: 新細明體,serif;">三、董事長、董事、監察人之姓名及住所。</span> </p><p><span style="font-family: 新細明體,serif;">四、財產種類及數額。</span> </p><p><span style="font-family: 新細明體,serif;">五、設立機構之所在地及類別與規模。</span> </p><p><span style="font-family: 新細明體,serif;">六、財產總額及各社員之出資額。</span> </p><p><span style="font-family: 新細明體,serif;">七、許可之年、月、日。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 49 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">法人不得為醫療社團法人之社員。</span> </p><p><span style="font-family: 新細明體,serif;">醫療社團法人每一社員不問出資多寡，均有一表決權。但得以章程訂定，按出資多寡比例分配表決權。</span> </p><p><span style="font-family: 新細明體,serif;">醫療社團法人得於章程中明定，社員按其出資額，保有對法人之財產權利，並得將其持分全部或部分轉讓於第三人。</span> </p><p><span style="font-family: 新細明體,serif;">前項情形，擔任董事、監察人之社員將其持分轉讓於第三人時，應向中央主管機關報備。其轉讓全部持分者，自動解任。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 50 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療社團法人之董事，以三人至九人為限；其中三分之二以上應具醫師及其他醫事人員資格。</span> </p><p><span style="font-family: 新細明體,serif;">外國人充任董事，其人數不得超過總名額三分之一，並不得充任董事長。</span> </p><p><span style="font-family: 新細明體,serif;">醫療社團法人應設監察人，其名額以董事名額之三分之一為限。</span> </p><p><span style="font-family: 新細明體,serif;">監察人不得兼任董事或職員。</span> </p><p><span style="font-family: 新細明體,serif;">董事會開會時，董事應親自出席，不得委託他人代理。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 51 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療社團法人組織章程之變更，應報經中央主管機關許可。</span> </p><p><span style="font-family: 新細明體,serif;">醫療社團法人董事長、董事、財產或其他登記事項如有變更，應依中央主管機關之規定，辦理變更登記。</span> </p><p><span style="font-family: 新細明體,serif;">醫療社團法人解散時，應辦理解散登記。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 52 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療社團法人之董事，任期屆滿未能改選或出缺未能補任，顯然妨礙董事會組織健全之虞者，中央主管機關得依其他董事、利害關係人之申請或依職權，命令限期召開臨時總會補選之。總會逾期不能召開，中央主管機關得選任董事充任之；其選任辦法，由中央主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">醫療社團法人之董事違反法令或章程，有損害該法人或其設立機構之利益或致其不能正常營運之虞者，中央主管機關得依其他董事或利害關係人之聲請或依職權，命令解任之。</span> </p><p><span style="font-family: 新細明體,serif;">醫療社團法人之董事會決議違反法令或章程，有損害該法人或其設立機構之利益或致其不能正常營運之虞者，中央主管機關得依職權，命令解散董事會，召開社員總會重新改選之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 53 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療社團法人結餘之分配，應提撥百分之十以上，辦理研究發展、人才培訓、健康教育、醫療救濟、社區醫療服務及其他社會服務事項基金；並應提撥百分之二十以上作為營運基金。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 54 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療社團法人，有下列情形之一者，解散之：</span> </p><p><span style="font-family: 新細明體,serif;">一、發生章程所定之解散事由。</span> </p><p><span style="font-family: 新細明體,serif;">二、設立目的不能達到時。</span> </p><p><span style="font-family: 新細明體,serif;">三、與其他醫療法人之合併。</span> </p><p><span style="font-family: 新細明體,serif;">四、破產。</span> </p><p><span style="font-family: 新細明體,serif;">五、中央主管機關撤銷設立許可或命令解散。</span> </p><p><span style="font-family: 新細明體,serif;">六、總會之決議。</span> </p><p><span style="font-family: 新細明體,serif;">七、欠缺社員。</span> </p><p><span style="font-family: 新細明體,serif;">依前項第一款事由解散時，應報請中央主管機關備查；依前項第二款至第七款事由解散時，應經中央主管機關之許可。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 55 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療社團法人解散後，除合併或破產外，其賸餘財產之歸屬，依組織章程之規定。</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">四</span> <span style="font-family: 新細明體,serif;">章</span> <span style="font-family: 新細明體,serif;">醫療業務</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 56 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療機構應依其提供服務之性質，具備適當之醫療場所及安全設施。</span> </p><p><span style="font-family: 新細明體,serif;">醫療機構對於所屬醫事人員執行直接接觸病人體液或血液之醫療處置時，應自中華民國一百零一年起，五年內按比例逐步完成全面提供安全針具。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 57 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療機構應督導所屬醫事人員，依各該醫事專門職業法規規定，執行業務。</span> </p><p><span style="font-family: 新細明體,serif;">醫療機構不得聘僱或容留未具醫事人員資格者，執行應由特定醫事人員執行之業務。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 58 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療機構不得置臨床助理執行醫療業務。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 59 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫院於診療時間外，應依其規模及業務需要，指派適當人數之醫師值班，以照顧住院及急診病人。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 60 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫院、診所遇有危急病人，應先予適當之急救，並即依其人員及設備能力予以救治或採取必要措施，不得無故拖延。</span> </p><p><span style="font-family: 新細明體,serif;">前項危急病人如係低收入或路倒病人，其醫療費用非本人或其扶養義務人所能負擔者，由直轄市、縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">政府社會行政主管機關依法補助之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 61 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療機構，不得以中央主管機關公告禁止之不正當方法，招攬病人。</span> </p><p><span style="font-family: 新細明體,serif;">醫療機構及其人員，不得利用業務上機會獲取不正當利益。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 62 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫院應建立醫療品質管理制度，並檢討評估。</span> </p><p><span style="font-family: 新細明體,serif;">為提升醫療服務品質，中央主管機關得訂定辦法，就特定醫療技術、檢查、檢驗或醫療儀器，規定其適應症、操作人員資格、條件及其他應遵行事項。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 63 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療機構實施手術，應向病人或其法定代理人、配偶、親屬或關係人說明手術原因、手術成功率或可能發生之併發症及危險，並經其同意，簽具手術同意書及麻醉同意書，始得為之。但情況緊急者，不在此限。</span> </p><p><span style="font-family: 新細明體,serif;">前項同意書之簽具，病人為未成年人或無法親自簽具者，得由其法定代理人、配偶、親屬或關係人簽具。</span> </p><p><span style="font-family: 新細明體,serif;">第一項手術同意書及麻醉同意書格式，由中央主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 64 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療機構實施中央主管機關規定之侵入性檢查或治療，應向病人或其法定代理人、配偶、親屬或關係人說明，並經其同意，簽具同意書後，始得為之。但情況緊急者，不在此限。</span> </p><p><span style="font-family: 新細明體,serif;">前項同意書之簽具，病人為未成年人或無法親自簽具者，得由其法定代理人、配偶、親屬或關係人簽具。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 65 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療機構對採取之組織檢體或手術切取之器官，應送請病理檢查，並將結果告知病人或其法定代理人、配偶、親屬或關係人。</span> </p><p><span style="font-family: 新細明體,serif;">醫療機構對於前項之組織檢體或手術切取之器官，應就臨床及病理診斷之結果，作成分析、檢討及評估。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 66 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫院、診所對於診治之病人交付藥劑時，應於容器或包裝上載明病人姓名、性別、藥名、劑量、數量、用法、作用或適應症、警語或副作用、醫療機構名稱與地點、調劑者姓名及調劑年、月、日。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 67 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療機構應建立清晰、詳實、完整之病歷。</span> </p><p><span style="font-family: 新細明體,serif;">前項所稱病歷，應包括下列各款之資料：</span> </p><p><span style="font-family: 新細明體,serif;">一、醫師依醫師法執行業務所製作之病歷。</span> </p><p><span style="font-family: 新細明體,serif;">二、各項檢查、檢驗報告資料。</span> </p><p><span style="font-family: 新細明體,serif;">三、其他各類醫事人員執行業務所製作之紀錄。</span> </p><p><span style="font-family: 新細明體,serif;">醫院對於病歷，應製作各項索引及統計分析，以利研究及查考。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 68 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療機構應督導其所屬醫事人員於執行業務時，親自記載病歷或製作紀錄，並簽名或蓋章及加註執行年、月、日。</span> </p><p><span style="font-family: 新細明體,serif;">前項病歷或紀錄如有增刪，應於增刪處簽名或蓋章及註明年、月、日；刪改部分，應以畫線去除，不得塗燬。</span> </p><p><span style="font-family: 新細明體,serif;">醫囑應於病歷載明或以書面為之。但情況急迫時，得先以口頭方式為之，並於二十四小時內完成書面紀錄。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 69 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療機構以電子文件方式製作及貯存之病歷，得免另以書面方式製作；其資格條件與製作方式、內容及其他應遵行事項之辦法，由中央主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 70 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療機構之病歷，應指定適當場所及人員保管，並至少保存七年。但未成年者之病歷，至少應保存至其成年後七年；人體試驗之病歷，應永久保存。</span> </p><p><span style="font-family: 新細明體,serif;">醫療機構因故未能繼續開業，其病歷應交由承接者依規定保存；無承接者時，病人或其代理人得要求醫療機構交付病歷；其餘病歷應繼續保存六個月以上，始得銷燬。</span> </p><p><span style="font-family: 新細明體,serif;">醫療機構具有正當理由無法保存病歷時，由地方主管機關保存。</span> </p><p><span style="font-family: 新細明體,serif;">醫療機構對於逾保存期限得銷燬之病歷，其銷燬方式應確保病歷內容無洩漏之虞。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 71 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療機構應依其診治之病人要求，提供病歷複製本，必要時提供中文病歷摘要，不得無故拖延或拒絕；其所需費用，由病人負擔。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 72 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療機構及其人員因業務而知悉或持有病人病情或健康資訊，不得無</span><span style="font-family: calibri;">&nbsp;&nbsp; </span></p><p><span style="font-family: 新細明體,serif;">故洩漏。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 73 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫院、診所因限於人員、設備及專長能力，無法確定病人之病因或提供完整治療時，應建議病人轉診。但危急病人應依第六十條第一項規定，先予適當之急救，始可轉診。</span> </p><p><span style="font-family: 新細明體,serif;">前項轉診，應填具轉診病歷摘要交予病人，不得無故拖延或拒絕。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 74 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫院、診所診治病人時，得依需要，並經病人或其法定代理人、配偶、親屬或關係人之同意，商洽病人原診治之醫院、診所，提供病歷複製本或病歷摘要及各種檢查報告資料。原診治之醫院、診所不得拒絕；其所需費用，由病人負擔。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 75 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫院得應出院病人之要求，為其安排適當之醫療場所及人員，繼續追蹤照顧。</span> </p><p><span style="font-family: 新細明體,serif;">醫院對尚未治癒而要求出院之病人，得要求病人或其法定代理人、配偶、親屬或關係人，簽具自動出院書。</span> </p><p><span style="font-family: 新細明體,serif;">病人經診治並依醫囑通知可出院時，應即辦理出院或轉院。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 76 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫院、診所如無法令規定之理由，對其診治之病人，不得拒絕開給出生證明書、診斷書、死亡證明書或死產證明書。開給各項診斷書時，應力求慎重，尤其是有關死亡之原因。</span> </p><p><span style="font-family: 新細明體,serif;">前項診斷書如係病人為申請保險理賠之用者，應以中文記載，所記病名如與保險契約病名不一致，另以加註方式為之。</span> </p><p><span style="font-family: 新細明體,serif;">醫院、診所對於非病死或可疑為非病死者，應報請檢察機關依法相驗。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 77 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療機構應接受政府委託，協助辦理公共衛生、繼續教育、在職訓練、災害救助、急難救助、社會福利及民防等有關醫療服務事宜。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 78 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">為提高國內醫療技術水準或預防疾病上之需要，教學醫院經擬定計畫，報請中央主管機關核准，或經中央主管機關委託者，得施行人體試驗。但學名藥生體可用率、生體相等性之人體試驗研究得免經中央主管機關之核准。</span> </p><p><span style="font-family: 新細明體,serif;">非教學醫院不得施行人體試驗。但醫療機構有特殊專長，經中央主管機關同意者，得準用前項規定。</span> </p><p><span style="font-family: 新細明體,serif;">醫療機構施行人體試驗應先將人體試驗計畫，提經醫療科技人員、法律專家及社會公正人士或民間團體代表，且任一性別不得低於三分之一之人員會同審查通過。審查人員並應遵守利益迴避原則。</span> </p><p><span style="font-family: 新細明體,serif;">人體試驗計畫內容變更時，應依前三項規定經審查及核准或同意後，始得施行。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 79 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療機構施行人體試驗時，應善盡醫療上必要之注意，並應先取得接受試驗者之書面同意；接受試驗者以有意思能力之成年人為限。但顯有益於特定人口群或特殊疾病罹患者健康權益之試驗，不在此限。</span> </p><p><span style="font-family: 新細明體,serif;">前項但書之接受試驗者為限制行為能力人，應得其本人與法定代理人同意；接受試驗者為無行為能力人，應得其法定代理人同意。</span> </p><p><span style="font-family: 新細明體,serif;">第一項書面，醫療機構應至少載明下列事項，並於接受試驗者或法定代理人同意前，以其可理解方式先行告知：</span> </p><p><span style="font-family: 新細明體,serif;">一、試驗目的及方法。</span> </p><p><span style="font-family: 新細明體,serif;">二、可預期風險及副作用。</span> </p><p><span style="font-family: 新細明體,serif;">三、預期試驗效果。</span> </p><p><span style="font-family: 新細明體,serif;">四、其他可能之治療方式及說明。</span> </p><p><span style="font-family: 新細明體,serif;">五、接受試驗者得隨時撤回同意之權利。</span> </p><p><span style="font-family: 新細明體,serif;">六、試驗有關之損害補償或保險機制。</span> </p><p><span style="font-family: 新細明體,serif;">七、受試者個人資料之保密。</span> </p><p><span style="font-family: 新細明體,serif;">八、受試者生物檢體、個人資料或其衍生物之保存與再利用。</span> </p><p><span style="font-family: 新細明體,serif;">前項告知及書面同意，醫療機構應給予充分時間考慮，並不得以脅迫或其他不正當方式為之。</span> </p><p><span style="font-family: 新細明體,serif;">醫師依前四項規定施行人體試驗，因試驗本身不可預見之因素，致病人死亡或傷害者，不符刑法第十三條或第十四條之故意或過失規定。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 79-1 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">除本法另有規定者外，前二條有關人體試驗之申請程序、審查作業基準及利益迴避原則、資訊揭露、監督管理、查核、其他告知內容等事項，由中央主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 79-2 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療機構對不同意參與人體試驗者或撤回同意之接受試驗者，應施行常規治療，不得減損其正當醫療權益。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 80 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療機構施行人體試驗期間，應依中央主管機關之通知提出試驗情形報告；中央主管機關認有安全之虞者，醫療機構應即停止試驗。</span> </p><p><span style="font-family: 新細明體,serif;">醫療機構於人體試驗施行完成時，應作成試驗報告，報請中央主管機關備查。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 81 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療機構診治病人時，應向病人或其法定代理人、配偶、親屬或關係人告知其病情、治療方針、處置、用藥、預後情形及可能之不良反應。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 82 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療業務之施行，應善盡醫療上必要之注意。</span> </p><p><span style="font-family: 新細明體,serif;">醫療機構及其醫事人員因執行業務致生損害於病人，以故意或過失為限，負損害賠償責任。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 83 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">司法院應指定法院設立醫事專業法庭，由具有醫事相關專業知識或審判經驗之法官，辦理醫事糾紛訴訟案件。</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">五</span> <span style="font-family: 新細明體,serif;">章</span> <span style="font-family: 新細明體,serif;">醫療廣告</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 84 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">非醫療機構，不得為醫療廣告。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 85 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療廣告，其內容以下列事項為限：</span> </p><p><span style="font-family: 新細明體,serif;">一、醫療機構之名稱、開業執照字號、地址、電話及交通路線。</span> </p><p><span style="font-family: 新細明體,serif;">二、醫師之姓名、性別、學歷、經歷及其醫師、專科醫師證書字號。</span> </p><p><span style="font-family: 新細明體,serif;">三、全民健康保險及其他非商業性保險之特約醫院、診所字樣。</span> </p><p><span style="font-family: 新細明體,serif;">四、診療科別及診療時間。</span> </p><p><span style="font-family: 新細明體,serif;">五、開業、歇業、停業、復業、遷移及其年、月、日。</span> </p><p><span style="font-family: 新細明體,serif;">六、其他經中央主管機關公告容許登載或播放事項。</span> </p><p><span style="font-family: 新細明體,serif;">利用廣播、電視之醫療廣告，在前項內容範圍內，得以口語化方式為之。</span> </p><p><span style="font-family: 新細明體,serif;">但應先經所在地直轄市或縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">主管機關核准。</span> </p><p><span style="font-family: 新細明體,serif;">醫療機構以網際網路提供之資訊，除有第一百零三條第二項各款所定情形外，不受第一項所定內容範圍之限制，其管理辦法由中央主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 86 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療廣告不得以下列方式為之：</span> </p><p><span style="font-family: 新細明體,serif;">一、假借他人名義為宣傳。</span> </p><p><span style="font-family: 新細明體,serif;">二、利用出售或贈與醫療刊物為宣傳。</span> </p><p><span style="font-family: 新細明體,serif;">三、以公開祖傳秘方或公開答問為宣傳。</span> </p><p><span style="font-family: 新細明體,serif;">四、摘錄醫學刊物內容為宣傳。</span> </p><p><span style="font-family: 新細明體,serif;">五、藉採訪或報導為宣傳。</span> </p><p><span style="font-family: 新細明體,serif;">六、與違反前條規定內容之廣告聯合或並排為宣傳。</span> </p><p><span style="font-family: 新細明體,serif;">七、以其他不正當方式為宣傳。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 87 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">廣告內容暗示或影射醫療業務者，視為醫療廣告。</span> </p><p><span style="font-family: 新細明體,serif;">醫學新知或研究報告之發表、病人衛生教育、學術性刊物，未涉及招徠醫療業務者，不視為醫療廣告。</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">六</span> <span style="font-family: 新細明體,serif;">章</span> <span style="font-family: 新細明體,serif;">醫事人力及設施分布</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 88 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">中央主管機關為促進醫療資源均衡發展，統籌規劃現有公私立醫療機構及人力合理分布，得劃分醫療區域，建立分級醫療制度，訂定醫療網計畫。</span> </p><p><span style="font-family: 新細明體,serif;">主管機關得依前項醫療網計畫，對醫療資源缺乏區域，獎勵民間設立醫療機構、護理之家機構；必要時，得由政府設立。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 89 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療區域之劃分，應考慮區域內醫療資源及人口分布，得超越行政區域之界限。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 90 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">中央主管機關訂定醫療網計畫時，直轄市、縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">主管機關應依該計畫，就轄區內醫療機構之設立或擴充，予以審查。但一定規模以上大型醫院之設立或擴充，應報由中央主管機關核准。</span> </p><p><span style="font-family: 新細明體,serif;">對於醫療設施過賸區域，主管機關得限制醫療機構或護理機構之設立或擴充。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 91 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">中央主管機關為促進醫療事業發展、提升醫療品質與效率及均衡醫療資源，應採取獎勵措施。</span> </p><p><span style="font-family: 新細明體,serif;">前項獎勵措施之項目、方式及其他配合措施之辦法，由中央主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 92 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">中央主管機關得設置醫療發展基金，供前條所定獎勵之用；其基金之收支、保管及運用辦法，由行政院定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 93 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療機構購置及使用具有危險性醫療儀器，中央主管機關於必要時得予審查及評估。</span> </p><p><span style="font-family: 新細明體,serif;">以公益為目的之社團法人或財團法人，於章程所定目的範圍內，為推動醫療技術升級發展研究計畫，而其投資金額逾一定門檻者，得經中央主管機關許可，依第三十條及第三十一條之規定設立醫療法人醫療機構，購置及使用具有危險性醫療儀器。</span> </p><p><span style="font-family: 新細明體,serif;">第一項所稱之具有危險性醫療儀器之項目及其審查及評估辦法，由中央主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">七</span> <span style="font-family: 新細明體,serif;">章</span> <span style="font-family: 新細明體,serif;">教學醫院</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 94 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">為提高醫療水準，醫院得申請評鑑為教學醫院。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 95 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">教學醫院之評鑑，由中央主管機關會商中央教育主管機關定期辦理。</span><span style="font-family: calibri;">&nbsp;&nbsp; </span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">中央主管機關應將教學醫院評鑑結果，以書面通知申請評鑑醫院，並</span><span style="font-family: calibri;">&nbsp; </span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">將評鑑合格之教學醫院名單及其資格有效期間等有關事項公告之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 96 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">教學醫院應擬具訓練計畫，辦理醫師及其他醫事人員訓練及繼續教</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">育，並接受醫學院、校學生臨床見習、實習。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">前項辦理醫師與其他醫事人員訓練及接受醫學院、校學生臨床見習、實習之人數，應依核定訓練容量為之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 97 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">教學醫院應按年編列研究發展及人才培訓經費，其所占之比率，不得</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">少於年度醫療收入總額百分之三。</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">八</span> <span style="font-family: 新細明體,serif;">章</span> <span style="font-family: 新細明體,serif;">醫事審議委員會</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 98 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">中央主管機關應設置醫事審議委員會，依其任務分別設置各種小組，其任務如下：</span> </p><p><span style="font-family: 新細明體,serif;">一、醫療制度之改進。</span> </p><p><span style="font-family: 新細明體,serif;">二、醫療技術之審議。</span> </p><p><span style="font-family: 新細明體,serif;">三、人體試驗之審議。</span> </p><p><span style="font-family: 新細明體,serif;">四、司法或檢察機關之委託鑑定。</span> </p><p><span style="font-family: 新細明體,serif;">五、專科醫師制度之改進。</span> </p><p><span style="font-family: 新細明體,serif;">六、醫德之促進。</span> </p><p><span style="font-family: 新細明體,serif;">七、一定規模以上大型醫院設立或擴充之審議。</span> </p><p><span style="font-family: 新細明體,serif;">八、其他有關醫事之審議。</span> </p><p><span style="font-family: 新細明體,serif;">前項醫事審議委員會之組織、會議等相關規定，由中央主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 99 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">直轄市、縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">主管機關應設置醫事審議委員會，任務如下：</span> </p><p><span style="font-family: 新細明體,serif;">一、醫療機構設立或擴充之審議。</span> </p><p><span style="font-family: 新細明體,serif;">二、醫療收費標準之審議。</span> </p><p><span style="font-family: 新細明體,serif;">三、醫療爭議之調處。</span> </p><p><span style="font-family: 新細明體,serif;">四、醫德之促進。</span> </p><p><span style="font-family: 新細明體,serif;">五、其他有關醫事之審議。</span> </p><p><span style="font-family: 新細明體,serif;">前項醫事審議委員會之組織、會議等相關規定，由直轄市、縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 100 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">前二條之醫事審議委員會委員，應就不具民意代表、醫療法人代表身分之醫事、法學專家、學者及社會人士遴聘之，其中法學專家及社會人士之比例，不得少於三分之一。</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">九</span> <span style="font-family: 新細明體,serif;">章</span> <span style="font-family: 新細明體,serif;">罰則</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 101 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">違反第十七條第一項、第十九條第一項、第二十條、第二十二條第一項、第二十三條第一項、第二十四條第一項、第五十六條第二項規定者，經予警告處分，並限期改善；屆期未改善者，處新臺幣一萬元以上五萬元以下罰鍰，按次連續處罰。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 102 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">有下列情形之一者，處新臺幣一萬元以上五萬元以下罰鍰，並令限期改善；屆期未改善者，按次連續處罰：</span> </p><p><span style="font-family: 新細明體,serif;">一、違反第二十五條第一項、第二十六條、第二十七條第一項、第五十九條、第六十條第一項、第六十五條、第六十六條、第六十七條第一項、第三項、第六十八條、第七十條、第七十一條、第七十三條、第七十四條、第七十六條或第八十條第二項規定。</span> </p><p><span style="font-family: 新細明體,serif;">二、違反中央主管機關依第十二條第三項規定所定之設置標準。</span> </p><p><span style="font-family: 新細明體,serif;">三、違反中央主管機關依第十三條規定所定之管理辦法。</span> </p><p><span style="font-family: 新細明體,serif;">四、違反中央主管機關依第六十九條規定所定之辦法。</span> </p><p><span style="font-family: 新細明體,serif;">有下列情形之一，經依前項規定處罰並令限期改善；屆期未改善者，得處一個月以上一年以下停業處分：</span> </p><p><span style="font-family: 新細明體,serif;">一、違反第二十五條第一項或第六十六條規定者。</span> </p><p><span style="font-family: 新細明體,serif;">二、違反中央主管機關依第十二條第三項規定所定之設置標準者。</span> </p><p><span style="font-family: 新細明體,serif;">三、違反中央主管機關依第十三條規定所定之管理辦法者。</span> </p><p><span style="font-family: 新細明體,serif;">四、違反中央主管機關依第六十九條規定所定之辦法者。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 103 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">有下列情形之一者，處新臺幣五萬元以上二十五萬元以下罰鍰：</span> </p><p><span style="font-family: 新細明體,serif;">一、違反第十五條第一項、第十七條第二項、第二十二條第二項、第二十三條第四項、第五項、第五十七條第一項、第六十一條、第六十三條第一項、第六十四條、第七十二條、第八十五條、第八十六條規定或擅自變更核准之廣告內容。</span> </p><p><span style="font-family: 新細明體,serif;">二、違反中央主管機關依第六十二條第二項、第九十三條第二項規定所定之辦法。</span> </p><p><span style="font-family: 新細明體,serif;">三、醫療機構聘僱或容留未具醫師以外之醫事人員資格者，執行應</span> <span style="font-family: 新細明體,serif;">由特定醫事人員執行之業務。</span> </p><p><span style="font-family: 新細明體,serif;">醫療廣告違反第八十五條、第八十六條規定或擅自變更核准內容者，除依前項規定處罰外，其有下列情形之一者，得處一個月以上一年以下停業處分或廢止其開業執照，並由中央主管機關吊銷其負責醫師之醫師證書一年：</span> </p><p><span style="font-family: 新細明體,serif;">一、內容虛偽、誇張、歪曲事實或有傷風化。</span> </p><p><span style="font-family: 新細明體,serif;">二、以非法墮胎為宣傳。</span> </p><p><span style="font-family: 新細明體,serif;">三、一年內已受處罰三次。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 104 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">違反第八十四條規定為醫療廣告者，處新臺幣五萬元以上二十五萬元以下罰鍰。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 105 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">違反第七十八條第一項或第二項規定，未經中央主管機關核准、委託或同意，施行人體試驗者，由中央主管機關處新臺幣二十萬元以上一百萬元以下罰鍰，並令其中止或終止人體試驗；情節重大者，並得處一個月以上一年以下停業處分或廢止其開業執照。</span> </p><p><span style="font-family: 新細明體,serif;">違反第七十八條第三項或中央主管機關依第七十九條之一授權所定辦法有關審查作業基準者，由中央主管機關處新臺幣十萬元以上五十萬元以下罰鍰，並得令其中止該項人體試驗或第七十八條第三項所定之審查。</span> </p><p><span style="font-family: 新細明體,serif;">違反第七十九條、第七十九條之二、第八十條第一項或中央主管機關依第七十九條之一授權所定辦法有關監督管理或查核事項之規定者，由中央主管機關處新臺幣十萬元以上五十萬元以下罰鍰，有安全或損害受試者權益之虞時，另得令其終止人體試驗；情節重大者，並得就其全部或一部之相關業務或違反規定之科別、服務項目，處一個月以上一年以下停業處分。</span> </p><p><span style="font-family: 新細明體,serif;">違反第七十八條第四項規定者，由中央主管機關處新臺幣五萬元以上二十五萬元以下罰鍰，並令其中止該人體試驗；情節重大者，並得令其終止該人體試驗。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 106 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">違反第二十四條第二項規定者，處新臺幣三萬元以上五萬元以下罰鍰。其觸犯刑法者，應移送司法機關辦理。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 107 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">違反第六十一條第二項、第六十二條第二項、第六十三條第一項、第六十四條第一項、第六十八條、第七十二條、第七十八條、第七十九條或第九十三條第二項規定者，除依第一百零二條、第一百零三條或第一百零五條規定處罰外，對其行為人亦處以各該條之罰鍰；其觸犯刑事法律者，並移送司法機關辦理。</span> </p><p><span style="font-family: 新細明體,serif;">前項行為人如為醫事人員，並依各該醫事專門職業法規規定懲處之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 108 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">醫療機構有下列情事之一者，處新臺幣五萬元以上五十萬元以下罰鍰，並得按其情節就違反規定之診療科別、服務項目或其全部或一部之門診、住院業務，處一個月以上一年以下停業處分或廢止其開業執照：</span> </p><p><span style="font-family: 新細明體,serif;">一、屬醫療業務管理之明顯疏失，致造成病患傷亡者。</span> </p><p><span style="font-family: 新細明體,serif;">二、明知與事實不符而記載病歷或出具診斷書、出生證明書、死亡證明書或死產證明書。</span> </p><p><span style="font-family: 新細明體,serif;">三、執行中央主管機關規定不得執行之醫療行為。</span> </p><p><span style="font-family: 新細明體,serif;">四、使用中央主管機關規定禁止使用之藥物。</span> </p><p><span style="font-family: 新細明體,serif;">五、容留違反醫師法第二十八條規定之人員執行醫療業務。</span> </p><p><span style="font-family: 新細明體,serif;">六、從事有傷風化或危害人體健康等不正當業務。</span> </p><p><span style="font-family: 新細明體,serif;">七、超收醫療費用或擅立收費項目收費經查屬實，而未依限將超收部分退還病人。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 109 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">醫療機構受停業處分而不停業者，廢止其開業執照。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 110 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">醫療機構受廢止開業執照處分者，其負責醫師於一年內不得在原址或其他處所申請設立醫療機構。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 111 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">醫療機構受廢止開業執照處分，仍繼續開業者，中央主管機關得吊銷其負責醫師之醫師證書二年。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 112 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">醫療法人違反第三十四條第五項、第三十七條第一項規定為保證人者，中央主管機關得處新臺幣十萬元以上五十萬元以下罰鍰，並得限期命其改善；逾期未改善者，得連續處罰之。其所為之保證，並由行為人自負保證責任。</span> </p><p><span style="font-family: 新細明體,serif;">醫療法人違反第三十七條第二項規定，除由中央主管機關得處董事長新臺幣十萬元以上五十萬元以下罰鍰外，醫療法人如有因而受損害時，行為人並應負賠償責任。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 113 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">醫療法人違反第三十四條第二項、第三十五條第一項或第四十條之規定者，中央主管機關得處新臺幣一萬元以上十萬元以下罰鍰，並限期命其補正。逾期未補正者，並得連續處罰之。</span> </p><p><span style="font-family: 新細明體,serif;">醫療法人有應登記之事項而未登記者，中央主管機關得對應申請登記之義務人處新臺幣一萬元以上十萬元以下罰鍰，並限期命其補正。逾期未補正者，並得連續處罰之。</span> </p><p><span style="font-family: 新細明體,serif;">前項情形，應申請登記之義務人為數人時，應全體負連帶責任。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 114 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">董事、監察人違反第四十九條第四項規定未報備者，中央主管機關得處該董事或監察人新臺幣五萬元以上二十萬元以下罰鍰。</span> </p><p><span style="font-family: 新細明體,serif;">醫療法人經許可設立後，未依其設立計畫書設立醫療機構，中央主管機關得限期命其改善；逾期未改善者，得廢止其許可。其設立計畫變更者，亦同。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 115 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">本法所定之罰鍰，於私立醫療機構，處罰其負責醫師。</span> </p><p><span style="font-family: 新細明體,serif;">本法所定之罰鍰，於醫療法人設立之醫療機構，處罰醫療法人。</span> </p><p><span style="font-family: 新細明體,serif;">第一項前段規定，於依第一百零七條規定處罰之行為人為負責醫師者，不另為處罰。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 116 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">本法所定之罰鍰、停業及廢止開業執照，除本法另有規定外，由直轄市、縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">主管機關處罰之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 117 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">依本法所處之罰鍰，經限期繳納，屆期未繳納者，依法移送強制執行。</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">十</span> <span style="font-family: 新細明體,serif;">章</span> <span style="font-family: 新細明體,serif;">附則</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 118 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">軍事機關所屬醫療機構及其附設民眾診療機構之設置及管理，依本法之規定。但所屬醫療機構涉及國防安全事務考量之部分，其管理依國防部之規定。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 119 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">本法修正施行前已設立之醫療機構與本法規定不符者，應於本法修正施行之日起一年內辦理補正；屆期不補正者，由原許可機關廢止其許可。但有特殊情況不能於一年內完成補正，經申請中央主管機關核准者，得展延之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 120 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">本法修正施行前領有中央主管機關核發之國術損傷接骨技術員登記證者繼續有效，其管理辦法由中央主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 121 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">中央主管機關辦理醫院評鑑，得收取評鑑費；直轄市、縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">主管機關依本法核發執照時，得收取執照費。</span> </p><p><span style="font-family: 新細明體,serif;">前項評鑑費及執照費之費額，由中央主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 122 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">本法施行細則，由中央主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 123 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">本法自公布日施行。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p> 2013-12-05 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=1024&type=0;;https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=1025&type=0;;https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6046&type=0
1420546 藥政管理類,藥事法 法律 藥事法 <p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">一</span> <span style="font-family: 新細明體,serif;">章</span> <span style="font-family: 新細明體,serif;">總則</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 1&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">藥事之管理，依本法之規定；本法未規定者，依其他有關法律之規定。但管制藥品管理條例有規定者，優先適用該條例之規定。</span> </p><p><span style="font-family: 新細明體,serif;">前項所稱藥事，指藥物、藥商、藥局及其有關事項。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 2&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本法所稱衛生主管機關：在中央為行政院衛生署；在直轄市為直轄市政府；在縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">為縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">政府。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 3&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">中央衛生主管機關得專設藥物管理機關，直轄市及縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">衛生主管機關於必要時亦得報准設置。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 4&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本法所稱藥物，係指藥品及醫療器材。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 5&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本法所稱試驗用藥物，係指醫療效能及安全尚未經證實，專供動物毒性藥理評估或臨床試驗用之藥物。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 6&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本法所稱藥品，係指左列各款之一之原料藥及製劑：</span> </p><p><span style="font-family: 新細明體,serif;">一、載於中華藥典或經中央衛生主管機關認定之其他各國藥典、公定之國家處方集，或各該補充典籍之藥品。</span> </p><p><span style="font-family: 新細明體,serif;">二、未載於前款，但使用於診斷、治療、減輕或預防人類疾病之藥品。</span> </p><p><span style="font-family: 新細明體,serif;">三、其他足以影響人類身體結構及生理機能之藥品。</span> </p><p><span style="font-family: 新細明體,serif;">四、用以配製前三款所列之藥品。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 7&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本法所稱新藥，係指經中央衛生主管機關審查認定屬新成分、新療效複方或新使用途徑製劑之藥品。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 8&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本法所稱製劑，係指以原料藥經加工調製，製成一定劑型及劑量之藥品。製劑分為醫師處方藥品、醫師藥師藥劑生指示藥品、成藥及固有成方製劑。</span> </p><p><span style="font-family: 新細明體,serif;">前項成藥之分類、審核、固有成方製劑製售之申請、成藥及固有成方製劑販賣之管理及其他應遵行事項之辦法，由中央衛生主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 9&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本法所稱成藥，係指原料藥經加工調製，不用其原名稱，其摻入之藥品，不超過中央衛生主管機關所規定之限量，作用緩和，無積蓄性，耐久儲存，使用簡便，並明示其效能、用量、用法，標明成藥許可證字號，其使用不待醫師指示，即供治療疾病之用者。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp; 10&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本法所稱固有成方製劑，係指依中央衛生主管機關選定公告具有醫療效能之傳統中藥處方調製</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">劑</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">之方劑。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp; 11&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本法所稱管制藥品，係指管制藥品管理條例第三條規定所稱之管制藥品。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp; 12&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本法所稱毒劇藥品，係指列載於中華藥典毒劇藥表中之藥品；表中未列載者，由中央衛生主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp; 13&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本法所稱醫療器材，係用於診斷、治療、減輕、直接預防人類疾病、調節生育，或足以影響人類身體結構及機能，且非以藥理、免疫或代謝方法作用於人體，以達成其主要功能之儀器、器械、用具、物質、軟體、體外試劑及其相關物品。</span> </p><p><span style="font-family: 新細明體,serif;">前項醫療器材，中央衛生主管機關應視實際需要，就其範圍、種類、管理及其他應管理事項，訂定醫療器材管理辦法規範之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp; 14&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本法所稱藥商，係指左列各款規定之業者：</span> </p><p><span style="font-family: 新細明體,serif;">一、藥品或醫療器材販賣業者。</span> </p><p><span style="font-family: 新細明體,serif;">二、藥品或醫療器材製造業者。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp; 15&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本法所稱藥品販賣業者，係指左列各款規定之業者：</span> </p><p><span style="font-family: 新細明體,serif;">一、經營西藥批發、零售、輸入及輸出之業者。</span> </p><p><span style="font-family: 新細明體,serif;">二、經營中藥批發、零售、調劑、輸入及輸出之業者。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp; 16&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本法所稱藥品製造業者，係指經營藥品之製造、加工與其產品批發、輸出及自用原料輸入之業者。</span> </p><p><span style="font-family: 新細明體,serif;">前項藥品製造業者輸入自用原料，應於每次進口前向中央衛生主管機關申請核准後，始得進口；已進口之自用原料，非經中央衛生主管機關核准，不得轉售或轉讓。</span> </p><p><span style="font-family: 新細明體,serif;">藥品製造業者，得兼營自製產品之零售業務。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp; 17&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本法所稱醫療器材販賣業者，係指經營醫療器材之批發、零售、輸入及輸出之業者。</span> </p><p><span style="font-family: 新細明體,serif;">經營醫療器材租賃業者，準用本法關於醫療器材販賣業者之規定。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp; 18&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本法所稱醫療器材製造業者，係指製造、裝配醫療器材，與其產品之批發、輸出及自用原料輸入之業者。</span> </p><p><span style="font-family: 新細明體,serif;">前項醫療器材製造業者，得兼營自製產品之零售業務。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp; 19&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本法所稱藥局，係指藥師或藥劑生親自主持，依法執行藥品調劑、供應業務之處所。</span> </p><p><span style="font-family: 新細明體,serif;">前項藥局得兼營藥品及一定等級之醫療器材零售業務。</span> </p><p><span style="font-family: 新細明體,serif;">前項所稱一定等級之醫療器材之範圍及種類，由中央衛生主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp; 20&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本法所稱偽藥，係指藥品經稽查或檢驗有左列各款情形之一者：</span> </p><p><span style="font-family: 新細明體,serif;">一、未經核准，擅自製造者。</span> </p><p><span style="font-family: 新細明體,serif;">二、所含有效成分之名稱，與核准不符者。</span> </p><p><span style="font-family: 新細明體,serif;">三、將他人產品抽換或摻雜者。</span> </p><p><span style="font-family: 新細明體,serif;">四、塗改或更換有效期間之標示者。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp; 21&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本法所稱劣藥，係指核准之藥品經稽查或檢驗有左列情形之一者：</span> </p><p><span style="font-family: 新細明體,serif;">一、擅自添加非法定著色劑、防腐劑、香料、矯味劑及賦形劑者。</span> </p><p><span style="font-family: 新細明體,serif;">二、所含有效成分之質、量或強度，與核准不符者。</span> </p><p><span style="font-family: 新細明體,serif;">三、藥品中一部或全部含有污穢或異物者。</span> </p><p><span style="font-family: 新細明體,serif;">四、有顯明變色、混濁、沈澱、潮解或已腐化分解者。</span> </p><p><span style="font-family: 新細明體,serif;">五、主治效能與核准不符者。</span> </p><p><span style="font-family: 新細明體,serif;">六、超過有效期間或保存期限者。</span> </p><p><span style="font-family: 新細明體,serif;">七、因儲藏過久或儲藏方法不當而變質者。</span> </p><p><span style="font-family: 新細明體,serif;">八、裝入有害物質所製成之容器或使用回收容器者。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp; 22&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本法所稱禁藥，係指藥品有左列各款情形之一者：</span> </p><p><span style="font-family: 新細明體,serif;">一、經中央衛生主管機關明令公告禁止製造、調劑、輸入、輸出、販賣或陳列之毒害藥品。</span> </p><p><span style="font-family: 新細明體,serif;">二、未經核准擅自輸入之藥品。但旅客或隨交通工具服務人員攜帶自用藥品進口者，不在此限。</span> </p><p><span style="font-family: 新細明體,serif;">前項第二款自用藥品之限量，由中央衛生主管機關會同財政部公告之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp; 23&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本法所稱不良醫療器材，係指醫療器材經稽查或檢驗有左列各款情形之一者：</span> </p><p><span style="font-family: 新細明體,serif;">一、使用時易生危險，或可損傷人體，或使診斷發生錯誤者。</span> </p><p><span style="font-family: 新細明體,serif;">二、含有毒質或有害物質，致使用時有損人體健康者。</span> </p><p><span style="font-family: 新細明體,serif;">三、超過有效期間或保存期限者。</span> </p><p><span style="font-family: 新細明體,serif;">四、性能或有效成分之質、量或強度，與核准不符者。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp; 24&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本法所稱藥物廣告，係指利用傳播方法，宣傳醫療效能，以達招徠銷售為目的之行為。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp; 25&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本法所稱標籤，係指藥品或醫療器材之容器上或包裝上，用以記載文字、圖畫或記號之標示物。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp; 26&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本法所稱仿單，係指藥品或醫療器材附加之說明書。</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">二</span> <span style="font-family: 新細明體,serif;">章</span> <span style="font-family: 新細明體,serif;">藥商之管理</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp; 27&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">凡申請為藥商者，應申請直轄市或縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">衛生主管機關核准登記，繳納執照費，領得許可執照後，方准營業；其登記事項如有變更時，應辦理變更登記。</span> </p><p><span style="font-family: 新細明體,serif;">前項登記事項，由中央衛生主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">藥商分設營業處所或分廠，仍應依第一項規定，各別辦理藥商登記。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 27-1&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">藥商申請停業，應將藥商許可執照及藥物許可證隨繳當地衛生主管機關，於執照上記明停業理由及期限，俟核准復業時發還之。每次停業期間不得超過一年，停業期滿未經當地衛生主管機關核准繼續停業者，應於停業期滿前三十日內申請復業。</span> </p><p><span style="font-family: 新細明體,serif;">藥商申請歇業時，應將其所領藥商許可執照及藥物許可證一併繳銷；其不繳銷者，由原發證照之衛生主管機關註銷。</span> </p><p><span style="font-family: 新細明體,serif;">藥商屆期不申請停業、歇業或復業登記，經直轄市或縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">衛生主管機關查核發現原址已無營業事實者，應由原發證照之衛生主管機關，將其有關證照註銷。</span> </p><p><span style="font-family: 新細明體,serif;">違反本法規定，經衛生主管機關處分停止其營業者，其證照依第一項規定辦理。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;28&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">西藥販賣業者之藥品及其買賣，應由專任藥師駐店管理。但不售賣麻醉藥品者，得由專任藥劑生為之。</span> </p><p><span style="font-family: 新細明體,serif;">中藥販賣業者之藥品及其買賣，應由專任中醫師或修習中藥課程達適當標準之藥師或藥劑生駐店管理。</span> </p><p><span style="font-family: 新細明體,serif;">西藥、中藥販賣業者，分設營業處所，仍應依第一項及第二項之規定。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;29&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">西藥製造業者，應由專任藥師駐廠監製；中藥製造業者，應由專任中醫師或修習中藥課程達適當標準之藥師駐廠監製。</span> </p><p><span style="font-family: 新細明體,serif;">中藥製造業者，以西藥劑型製造中藥，或摻入西藥製造中藥時，除依前項規定外，應由專任藥師監製。</span> </p><p><span style="font-family: 新細明體,serif;">西藥、中藥製造業者，設立分廠，仍應依前二項規定辦理。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;30&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">藥商聘用之藥師、藥劑生或中醫師，如有解聘或辭聘，應即另聘。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;31&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">從事人用生物藥品製造業者，應聘用國內外大學院校以上醫藥或生物學等系畢業，具有微生物學、免疫學藥品製造專門知識，並有五年以上製造經驗之技術人員，駐廠負責製造。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;32 &nbsp;&nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療器材販賣或製造業者，應視其類別，聘用技術人員。</span> </p><p><span style="font-family: 新細明體,serif;">前項醫療器材類別及技術人員資格，由中央衛生主管機關定之。</span> <span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;33&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">藥商僱用之推銷員，應由該業者向當地之直轄市、縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">衛生</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: 新細明體,serif;">主管機關登記後，方准執行推銷工作。</span> </p><p><span style="font-family: 新細明體,serif;">前項推銷員，以向藥局、藥商、衛生醫療機構、醫學研究機構及經衛生主管機關准予登記為兼售藥物者推銷其受僱藥商所製售或經銷之藥物為限，</span> </p><p><span style="font-family: 新細明體,serif;">並不得有沿途推銷、設攤出售或擅將藥物拆封、改裝或非法廣告之行為。</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">三</span> <span style="font-family: 新細明體,serif;">章</span> <span style="font-family: 新細明體,serif;">藥局之管理及藥品之調劑</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;34 &nbsp;&nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">藥局應請領藥局執照，並於明顯處標示經營者之身分姓名。其設立、變更登記，準用第二十七條第一項之規定。</span> </p><p><span style="font-family: 新細明體,serif;">藥局兼營第十九條第二項之業務，應適用關於藥商之規定。但無須另行請領藥商許可執照。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;35&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">修習中藥課程達適當標準之藥師，親自主持之藥局，得兼營中藥之調劑、供應或零售業務。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;36&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">藥師親自主持之藥局，具有鑑定設備者，得執行藥品之鑑定業務。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;37&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">藥品之調劑，非依一定作業程序，不得為之；其作業準則，由中央衛生主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">前項調劑應由藥師為之。但不含麻醉藥品者，得由藥劑生為之。</span> </p><p><span style="font-family: 新細明體,serif;">醫院中之藥品之調劑，應由藥師為之。但本法八十二年二月五日修正施行前已在醫院中服務之藥劑生，適用前項規定，並得繼續或轉院任職。</span> </p><p><span style="font-family: 新細明體,serif;">中藥之調劑，除法律另有規定外，應由中醫師監督為之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;38 &nbsp;&nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">藥師法第十二條、第十六條至第二十條之規定，於藥劑生調劑藥品時準用之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">四</span> <span style="font-family: 新細明體,serif;">章</span> <span style="font-family: 新細明體,serif;">藥物之查驗登記</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;39&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">製造、輸入藥品，應將其成分、規格、性能、製法之要旨，檢驗規格與方法及有關資料或證件，連同原文和中文標籤、原文和中文仿單及樣品，並繳納費用，申請中央衛生主管機關查驗登記，經核准發給藥品許可證後，始得製造或輸入。</span> </p><p><span style="font-family: 新細明體,serif;">向中央衛生主管機關申請藥品試製經核准輸入原料藥者，不適用前項規定；其申請條件及應繳費用，由中央衛生主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">第一項輸入藥品，應由藥品許可證所有人及其授權者輸入。</span> </p><p><span style="font-family: 新細明體,serif;">申請第一項藥品查驗登記、依第四十六條規定辦理藥品許可證變更、移轉登記及依第四十七條規定辦理藥品許可證展延登記、換發及補發，其申請條件、審查程序、核准基準及其他應遵行之事項，由中央衛生主管機關以藥品查驗登記審查準則定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;40&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">製造、輸入醫療器材，應向中央衛生主管機關申請查驗登記並繳納費用，經核准發給醫療器材許可證後，始得製造或輸入。</span> </p><p><span style="font-family: 新細明體,serif;">前項輸入醫療器材，應由醫療器材許可證所有人或其授權者輸入。</span> </p><p><span style="font-family: 新細明體,serif;">申請醫療器材查驗登記、許可證變更、移轉、展延登記、換發及補發，其申請條件、審查程序、核准基準及其他應遵行之事項，由中央衛生主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 40-1 &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">中央衛生主管機關為維護公益之目的，於必要時，得公開所持有及保管藥商申請製造或輸入藥物所檢附之藥物成分、仿單等相關資料。但對於藥商申請新藥查驗登記屬於營業秘密之資料，應保密之。</span> </p><p><span style="font-family: 新細明體,serif;">前項得公開事項之範圍及方式，其辦法由中央衛生主管機關定之。</span> <span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;40-2 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">中央衛生主管機關於核發新藥許可證時，應公開申請人檢附之已</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: 新細明體,serif;">揭露專利字號或案號。</span> </p><p><span style="font-family: 新細明體,serif;">新成分新藥許可證自核發之日起五年內，其他藥商非經許可證所有人同意，不得引據其申請資料申請查驗登記。</span> </p><p><span style="font-family: 新細明體,serif;">新成分新藥許可證核發之日起三年後，其他藥商得依本法及相關法規有關藥品查驗登記審查之規定提出同成分、同劑型、同劑量及同單位含量藥品之查驗登記申請，符合規定者，得於新成分新藥許可證核發屆滿五年之翌日起發給藥品許可證。</span> </p><p><span style="font-family: 新細明體,serif;">新成分新藥在外國取得上市許可後三年內，必須向中央衛生主管機關申請查驗登記，始得準用第二項之規定。</span> </p><p><span style="font-family: 新細明體,serif;">新藥專利權不及於藥商申請查驗登記前所進行之研究、教學或試驗。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;41&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">為提昇藥物製造工業水準與臨床試驗品質，對於藥物科技之研究發展，中央衛生主管機關每年應委託專業醫療團體辦理教育訓練，培育臨床試驗人才。</span> </p><p><span style="font-family: 新細明體,serif;">新興藥物科技之研究發展，得由中央衛生主管機關會同中央工業主管機關獎勵之。</span> </p><p><span style="font-family: 新細明體,serif;">前項獎勵之資格條件、審議程序及其他應遵行事項之辦法，由中央衛生主管機關會同中央工業主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;42&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">中央衛生主管機關對於製造、輸入之藥物，應訂定作業準則，作為核發、變更及展延藥物許可證之基準。</span> </p><p><span style="font-family: 新細明體,serif;">前項作業準則，由中央衛生主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;43 &nbsp;&nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">製造、輸入藥物之查驗登記申請書及輸出藥物之申請書，其格式、樣品份數、有關資料或證書費、查驗費之金額，由中央衛生主管機關定之。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;44 &nbsp;&nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">試驗用藥物，應經中央衛生主管機關核准始得供經核可之教學醫院臨床試驗，以確認其安全與醫療效能。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;45 &nbsp;&nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">經核准製造或輸入之藥物，中央衛生主管機關得指定期間，監視其安全性。</span> </p><p><span style="font-family: 新細明體,serif;">藥商於前項安全監視期間應遵行事項，由中央衛生主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 45-1 &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療機構、藥局及藥商對於因藥物所引起之嚴重不良反應，應行通報；其方式、內容及其他應遵行事項之辦法，由中央衛生主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;46 &nbsp;&nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">經核准製造、輸入之藥物，非經中央衛生主管機關之核准，不得變更原登記事項。</span> </p><p><span style="font-family: 新細明體,serif;">經核准製造、輸入之藥物許可證，如有移轉時，應辦理移轉登記。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;47&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">藥物製造、輸入許可證有效期間為五年，期滿仍須繼續製造、輸入者，應事先申請中央衛生主管機關核准展延之。但每次展延，不得超過五年。屆期未申請或不准展延者，註銷其許可證。</span> </p><p><span style="font-family: 新細明體,serif;">前項許可證如有污損或遺失，應敘明理由，申請原核發機關換發或補發，並應將原許可證同時繳銷，或由核發機關公告註銷。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;48&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">藥物於其製造、輸入許可證有效期間內，經中央衛生主管機關重新評估確定有安全或醫療效能疑慮者，得限期令藥商改善，屆期未改善者，廢止其許可證。但安全疑慮重大者，得逕予廢止之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 48-1 &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">第三十九條第一項製造、輸入藥品，應標示中文標籤、仿單或包裝，始得買賣、批發、零售。但經中央衛生主管機關認定有窒礙難行者，不在此限。</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">五</span> <span style="font-family: 新細明體,serif;">章</span> <span style="font-family: 新細明體,serif;">藥物之販賣及製造</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;49&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">藥商不得買賣來源不明或無藥商許可執照者之藥品或醫療器材。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;50&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">須由醫師處方之藥品，非經醫師處方，不得調劑供應。但左列各款情形不在此限：</span> </p><p><span style="font-family: 新細明體,serif;">一、同業藥商之批發、販賣。</span> </p><p><span style="font-family: 新細明體,serif;">二、醫院、診所及機關、團體、學校之醫療機構或檢驗及學術研究機構之購買。</span> </p><p><span style="font-family: 新細明體,serif;">三、依中華藥典、國民處方選輯處方之調劑。</span> </p><p><span style="font-family: 新細明體,serif;">前項須經醫師處方之藥品，由中央衛生主管機關就中、西藥品分別定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;51&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">西藥販賣業者，不得兼售中藥；中藥販賣業者，不得兼售西藥。但成藥不在此限。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;52&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">藥品販賣業者，不得兼售農藥、動物用藥品或其他毒性化學物質。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;53&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">藥品販賣業者輸入之藥品得分裝後出售，其分裝應依下列規定辦理：</span> </p><p><span style="font-family: 新細明體,serif;">一、製劑：申請中央衛生主管機關核准後，由符合藥品優良製造規範之藥品製造業者分裝。</span> </p><p><span style="font-family: 新細明體,serif;">二、原料藥：由符合藥品優良製造規範之藥品製造業者分裝；分裝後，應報請中央衛生主管機關備查。</span> </p><p><span style="font-family: 新細明體,serif;">前項申請分裝之條件、程序、報請備查之期限、程序及其他分裝出售所應遵循之事項，由中央衛生主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;54&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">藥品或醫療器材經核准發給藥物輸入許可證後，為維護國家權益，中央衛生主管機關得加以管制。但在管制前已核准結匯簽證者，不在此限。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;55&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">經核准製造或輸入之藥物樣品或贈品，不得出售。</span> </p><p><span style="font-family: 新細明體,serif;">前項樣品贈品管理辦法，由中央衛生主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;56&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">經核准製售之藥物，如輸出國外銷售時，其應輸入國家要求證明文字者，應於輸出前，由製造廠商申請中央衛生主管機關發給輸出證明書。</span> </p><p><span style="font-family: 新細明體,serif;">前項藥物，中央衛生主管機關認有不敷國內需要之虞時，得限制其輸出。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;57&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">製造藥物，應由藥物製造工廠為之；藥物製造工廠，應依藥物製造工廠設廠標準設立，並依工廠管理輔導法規定，辦理工廠登記。但依工廠管理輔導法規定免辦理工廠登記，或經中央衛生主管機關核准為研發而製造者，不在此限。</span> </p><p><span style="font-family: 新細明體,serif;">藥物製造，其廠房設施、設備、組織與人事、生產、品質管制、儲存、運銷、客戶申訴及其他應遵行事項，應符合藥物優良製造準則之規定，並經中央衛生主管機關檢查合格，取得藥物製造許可後，始得製造。但經中央衛生主管機關公告無需符合藥物優良製造準則之醫療器材製造業者，不在此限。</span> </p><p><span style="font-family: 新細明體,serif;">符合前項規定，取得藥物製造許可之藥商，得繳納費用，向中央衛生主管機關申領證明文件。</span> </p><p><span style="font-family: 新細明體,serif;">輸入藥物之國外製造廠，準用前二項規定，並由中央衛生主管機關定期或依實際需要赴國外製造廠檢查之。</span> </p><p><span style="font-family: 新細明體,serif;">第一項藥物製造工廠設廠標準，由中央衛生主管機關會同中央工業主管機關定之；第二項藥物優良製造準則，由中央衛生主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">第二項藥物製造許可與第三項證明文件之申請條件、審查程序與基準、核發、效期、廢止、返還、註銷及其他應遵行事項之辦法，由中央衛生主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 57-1 &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">從事藥物研發之機構或公司，其研發用藥物，應於符合中央衛生主管機關規定之工廠或場所製造。</span> </p><p><span style="font-family: 新細明體,serif;">前項工廠或場所非經中央衛生主管機關核准，不得兼製其他產品；其所製造之研發用藥物，非經中央衛生主管機關核准，不得使用於人體。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;58&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">藥物工廠，非經中央衛生主管機關核准，不得委託他廠製造或接受委託製造藥物。</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">六</span> <span style="font-family: 新細明體,serif;">章</span> <span style="font-family: 新細明體,serif;">管制藥品及毒劇藥品之管理</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp; 59&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">西藥販賣業者及西藥製造業者，購存或售賣管制藥品及毒劇藥品，應將藥品名稱、數量，詳列簿冊，以備檢查。管制藥品並應專設櫥櫃加鎖儲藏。管制藥品及毒劇藥品之標籤，應載明警語及足以警惕之圖案或顏色。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;60&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">管制藥品及毒劇藥品，須有醫師之處方，始得調劑、供應。</span> </p><p><span style="font-family: 新細明體,serif;">前項管制藥品應憑領受人之身分證明並將其姓名、地址、統一編號及所領受品量，詳錄簿冊，連同處方箋保存之，以備檢查。</span> </p><p><span style="font-family: 新細明體,serif;">管制藥品之處方及調劑，中央衛生主管機關得限制之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;61&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">（刪除）</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;62&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">第五十九條及第六十條所規定之處方箋、簿冊，均應保存五年。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;63&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">（刪除）</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;64&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">中藥販賣業者及中藥製造業者，非經中央衛生主管機關核准，不得售賣或使用管制藥品。</span> </p><p><span style="font-family: 新細明體,serif;">中藥販賣業者及中藥製造業者售賣毒劇性之中藥，非有中醫師簽名、蓋章之處方箋，不得出售；其購存或出售毒劇性中藥，準用第五十九條之規定。</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">七</span> <span style="font-family: 新細明體,serif;">章</span> <span style="font-family: 新細明體,serif;">藥物廣告之管理</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;65&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">非藥商不得為藥物廣告。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;66&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">藥商刊播藥物廣告時，應於刊播前將所有文字、圖畫或言詞，申請中央或直轄市衛生主管機關核准，並向傳播業者送驗核准文件。原核准機關發現已核准之藥物廣告內容或刊播方式危害民眾健康或有重大危害之虞時，應令藥商立即停止刊播並限期改善，屆期未改善者，廢止之。</span> </p><p><span style="font-family: 新細明體,serif;">藥物廣告在核准登載、刊播期間不得變更原核准事項。</span> </p><p><span style="font-family: 新細明體,serif;">傳播業者不得刊播未經中央或直轄市衛生主管機關核准、與核准事項不符、已廢止或經令立即停止刊播並限期改善而尚未改善之藥物廣告。</span> </p><p><span style="font-family: 新細明體,serif;">接受委託刊播之傳播業者，應自廣告之日起六個月，保存委託刊播廣告者之姓名</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">法人或團體名稱</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">、身分證或事業登記證字號、住居所</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">事務所或營業所</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">及電話等資料，且於主管機關要求提供時，不得規避、妨礙或拒絕。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 66-1 &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">藥物廣告，經中央或直轄市衛生主管機關核准者，其有效期間為一年，自核發證明文件之日起算。期滿仍需繼續廣告者，得申請原核准之衛生主管機關核定展延之；每次展延之期間，不得超過一年。</span> </p><p><span style="font-family: 新細明體,serif;">前項有效期間，應記明於核准該廣告之證明文件。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;67&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">須由醫師處方或經中央衛生主管機關公告指定之藥物，其廣告以登載於學術性醫療刊物為限。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;68&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">藥物廣告不得以左列方式為之：</span> </p><p><span style="font-family: 新細明體,serif;">一、假借他人名義為宣傳者。</span> </p><p><span style="font-family: 新細明體,serif;">二、利用書刊資料保證其效能或性能。</span> </p><p><span style="font-family: 新細明體,serif;">三、藉採訪或報導為宣傳。</span> </p><p><span style="font-family: 新細明體,serif;">四、以其他不正當方式為宣傳。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;69&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">非本法所稱之藥物，不得為醫療效能之標示或宣傳。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;70&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">採訪、報導或宣傳，其內容暗示或影射醫療效能者，視為藥物廣告。</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">八</span> <span style="font-family: 新細明體,serif;">章</span> <span style="font-family: 新細明體,serif;">稽查及取締</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;71&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">衛生主管機關，得派員檢查藥物製造業者，販賣業者之處所設施及有關業務，並得出具單據抽驗其藥物，業者不得無故拒絕。但抽驗數量以足供檢驗之用者為限。</span> </p><p><span style="font-family: 新細明體,serif;">藥物製造業者之檢查，必要時得會同工業主管機關為之。</span> </p><p><span style="font-family: 新細明體,serif;">本條所列實施檢查辦法，由中央衛生主管機關會同中央工業主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 71-1 &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">為加強輸入藥物之邊境管理，中央衛生主管機關得公告其輸入時應抽查、檢驗合格後，始得輸入。</span> </p><p><span style="font-family: 新細明體,serif;">前項輸入藥物之抽查及檢驗方式、方法、項目、範圍、收費及其他應遵行事項之辦法，由中央衛生主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;72&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">衛生主管機關得派員檢查醫療機構或藥局之有關業務，並得出具單據抽驗其藥物，受檢者不得無故拒絕。但抽驗數量以足供檢驗之用者為限。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;73&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">直轄市、縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">衛生主管機關應每年定期辦理藥商及藥局普查。</span> </p><p><span style="font-family: 新細明體,serif;">藥商或藥局對於前項普查，不得拒絕、規避或妨礙。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;74&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">依據微生物學、免疫學學理製造之血清、抗毒素、疫苗、類毒素及菌液等，非經中央衛生主管機關於每批產品輸入或製造後，派員抽取樣品，經檢驗合格，並加貼查訖封緘，不得銷售。檢驗封緘作業辦法，由中央衛生主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">前項生物藥品之原液，其輸入以生物藥品製造業者為限。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;75&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">藥物之標籤、仿單或包裝，應依核准，分別刊載左列事項：</span> </p><p><span style="font-family: 新細明體,serif;">一、廠商名稱及地址。</span> </p><p><span style="font-family: 新細明體,serif;">二、品名及許可證字號。</span> </p><p><span style="font-family: 新細明體,serif;">三、批號。</span> </p><p><span style="font-family: 新細明體,serif;">四、製造日期及有效期間或保存期限。</span> </p><p><span style="font-family: 新細明體,serif;">五、主要成分含量、用量及用法。</span> </p><p><span style="font-family: 新細明體,serif;">六、主治效能、性能或適應症。</span> </p><p><span style="font-family: 新細明體,serif;">七、副作用、禁忌及其他注意事項。</span> </p><p><span style="font-family: 新細明體,serif;">八、其他依規定應刊載事項。</span> </p><p><span style="font-family: 新細明體,serif;">前項第四款經中央衛生主管機關明令公告免予刊載者，不在此限。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;76&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">經許可製造、輸入之藥物，經發現有重大危害時，中央衛生主管機關除應隨時公告禁止其製造、輸入外，並廢止其藥物許可證；其已製造或輸入者，應限期禁止其輸出、調劑、販賣、供應、運送、寄藏、牙保、轉讓或意圖販賣而陳列，必要時並得沒入銷燬之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;77&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">直轄市或縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">衛生主管機關，對於涉嫌之偽藥、劣藥、禁藥或不良醫療器材，就偽藥、禁藥部分，應先行就地封存，並抽取樣品予以檢驗後，再行處理；就劣藥、不良醫療器材部分，得先行就地封存，並抽取樣品予以檢驗後，再行處理。其對衛生有重大危害者，應於報請中央衛生主管機關核准後，沒入銷燬之。</span> </p><p><span style="font-family: 新細明體,serif;">前項規定於未經核准而製造、輸入之醫療器材，準用之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;78&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">經稽查或檢驗為偽藥、劣藥、禁藥及不良醫療器材，除依本法有關規定處理外，並應為下列處分：</span> </p><p><span style="font-family: 新細明體,serif;">一、製造或輸入偽藥、禁藥及頂替使用許可證者，應由原核准機關，廢止其全部藥物許可證、藥商許可執照、藥物製造許可及公司、商業、工廠之全部或部分登記事項。</span> </p><p><span style="font-family: 新細明體,serif;">二、販賣或意圖販賣而陳列偽藥、禁藥者，由直轄市或縣（市）衛生主管機關，公告其公司或商號之名稱、地址、負責人姓名、藥品名稱及違反情節；再次違反者，得停止其營業。</span> </p><p><span style="font-family: 新細明體,serif;">三、製造、輸入、販賣或意圖販賣而陳列劣藥、不良醫療器材者，由直轄市或縣（市）衛生主管機關，公告其公司或商號之名稱、地址、負責人姓名、藥物名稱及違反情節；其情節重大或再次違反者，得廢止其各該藥物許可證、藥物製造許可及停止其營業。</span> </p><p><span style="font-family: 新細明體,serif;">前項規定，於未經核准而製造、輸入之醫療器材，準用之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;79&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">查獲之偽藥或禁藥，沒入銷燬之。</span> </p><p><span style="font-family: 新細明體,serif;">查獲之劣藥或不良醫療器材，如係本國製造，經檢驗後仍可改製使用者，應由直轄市或縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">衛生主管機關，派員監督原製造廠商限期改製；其不能改製或屆期未改製者，沒入銷燬之；如係核准輸入者，應即封存，並由直轄市或縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">衛生主管機關責令原進口商限期退運出口，屆期未能退貨者，沒入銷燬之。</span> </p><p><span style="font-family: 新細明體,serif;">前項規定於經依法認定為未經核准而製造、輸入之醫療器材，準用之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;80&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">藥物有下列情形之一者，其製造或輸入之業者，應即通知醫療機構、藥局及藥商，並依規定期限回收市售品，連同庫存品一併依本法有關規定處理：</span> </p><p><span style="font-family: 新細明體,serif;">一、原領有許可證，經公告禁止製造或輸入。</span> </p><p><span style="font-family: 新細明體,serif;">二、經依法認定為偽藥、劣藥或禁藥。</span> </p><p><span style="font-family: 新細明體,serif;">三、經依法認定為不良醫療器材或未經核准而製造、輸入之醫療器材。</span> </p><p><span style="font-family: 新細明體,serif;">四、藥物製造工廠，經檢查發現其藥物確有損害使用者生命、身體或健康之事實，或有損害之虞。</span> </p><p><span style="font-family: 新細明體,serif;">五、製造、輸入藥物許可證未申請展延或不准展延。</span> </p><p><span style="font-family: 新細明體,serif;">六、包裝、標籤、仿單經核准變更登記。</span> </p><p><span style="font-family: 新細明體,serif;">七、其他經中央衛生主管機關公告應回收。</span> </p><p><span style="font-family: 新細明體,serif;">製造、輸入業者回收前項各款藥物時，醫療機構、藥局及藥商應予配合。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;81&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">舉發或緝獲偽藥、劣藥、禁藥及不良醫療器材，應予獎勵。</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">九</span> <span style="font-family: 新細明體,serif;">章</span> <span style="font-family: 新細明體,serif;">罰則</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;82&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">製造或輸入偽藥或禁藥者，處十年以下有期徒刑，得併科新臺幣一千萬元以下罰金。</span> </p><p><span style="font-family: 新細明體,serif;">犯前項之罪，因而致人於死者，處無期徒刑或十年以上有期徒刑，致重傷者，處七年以上有期徒刑。</span> </p><p><span style="font-family: 新細明體,serif;">因過失犯第一項之罪者，處三年以下有期徒刑、拘役或科新臺幣五十萬元以下罰金。</span> </p><p><span style="font-family: 新細明體,serif;">第一項之未遂犯罰之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;83&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">明知為偽藥或禁藥，而販賣、供應、調劑、運送、寄藏、牙保、轉讓或意圖販賣而陳列者，處七年以下有期徒刑，得併科新臺幣五百萬元以下罰金。</span> </p><p><span style="font-family: 新細明體,serif;">犯前項之罪，因而致人於死者，處七年以上有期徒刑，致重傷者，處三年以上十二年以下有期徒刑。</span> </p><p><span style="font-family: 新細明體,serif;">因過失犯第一項之罪者，處二年以下有期徒刑、拘役或科新臺幣三十萬元以下罰金。</span> </p><p><span style="font-family: 新細明體,serif;">第一項之未遂犯罰之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;84&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">未經核准擅自製造或輸入醫療器材者，處三年以下有期徒刑，得併科新台幣十萬元以下罰金。</span> </p><p><span style="font-family: 新細明體,serif;">明知為前項之醫療器材而販賣、供應、運送、寄藏、牙保、轉讓或意圖販賣而陳列者，依前項規定處罰之。</span> </p><p><span style="font-family: 新細明體,serif;">因過失犯前項之罪者，處六月以下有期徒刑、拘役或新台幣五萬元以下罰金。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;85&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">製造或輸入第二十一條第一款之劣藥或第二十三條第一款、第二款之不良醫療器材者，處一年以下有期徒刑或拘役，得併科新台幣三萬元以下罰金。</span> </p><p><span style="font-family: 新細明體,serif;">因過失犯前項之罪或明知為前項之劣藥或不良醫療器材，而販賣、供應、調劑、運送、寄藏、牙保、轉讓或意圖販賣而陳列者，處六月以下有期徒刑或拘役，得併科新台幣一萬元以下罰金。</span> </p><p><span style="font-family: 新細明體,serif;">因過失而販賣、供應、調劑、運送、寄藏、牙保、轉讓或意圖販賣而陳列第一項之劣藥或不良醫療器材者，處拘役或新台幣一萬元以下罰金。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;86&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">擅用或冒用他人藥物之名稱、仿單或標籤者，處一年以下有期徒刑、拘役或科或併科新台幣五萬元以下罰金。</span> </p><p><span style="font-family: 新細明體,serif;">明知為前項之藥物而輸入、販賣、供應、調劑、運送、寄藏、牙保、轉讓或意圖販賣而陳列者，處六月以下有期徒刑、拘役或科或併科新台幣三萬元以下罰金。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;87&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">法人之代表人，法人或自然人之代理人、受雇人，或其他從業人員，因執行業務，犯第八十二條至第八十六條之罪者，除依各該條規定處罰其行為人外，對該法人或自然人亦科以各該條之罰金。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;88&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">依本法查獲供製造、調劑偽藥、禁藥之器材，不問屬於犯人與否，沒收之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;89&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">公務員假借職務上之權力、機會或方法，犯本章各條之罪或包庇他人犯本章各條之罪者，依各該條之規定，加重其刑至二分之一。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;90&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">製造或輸入第二十一條第二款至第八款之劣藥或第二十三條第三款、第四款之不良醫療器材者，處新台幣六萬元以上三十萬元以下罰鍰。</span> </p><p><span style="font-family: 新細明體,serif;">販賣、供應、調劑、運送、寄藏、牙保、轉讓或意圖販賣而陳列前項之劣藥或不良醫療器材者，處新台幣三萬元以上十五萬元以下罰鍰。</span> </p><p><span style="font-family: 新細明體,serif;">犯前二項規定之一者，對其藥物管理人、監製人，亦處以各該項之罰鍰。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;91&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">違反第六十五條或第八十條第一項第一款至第四款規定之一者，處新臺幣二十萬元以上五百萬元以下罰鍰。</span> </p><p><span style="font-family: 新細明體,serif;">違反第六十九條規定者，處新臺幣六十萬元以上二千五百萬元以下罰鍰，其違法物品沒入銷燬之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;92&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">違反第二十七條第一項、第三項、第二十九條、第三十一條、第三十六條、第三十七條第二項、第三項、第三十九條第一項、第四十條第一項、第四十四條、第四十五條之一、第四十六條、第四十九條、第五十條第一項、第五十一條至第五十三條、第五十五條第一項、第五十七條第一項、第二項、第四項、第五十七條之一、第五十八條、第五十九條、第六十條、第六十四條、第七十一條第一項、第七十二條、第七十四條、第七十五條規定之一者，處新臺幣三萬元以上十五萬元以下罰鍰。</span> </p><p><span style="font-family: 新細明體,serif;">違反第五十九條規定，或調劑、供應毒劇藥品違反第六十條第一項規定者，對其藥品管理人、監製人，亦處以前項之罰鍰。</span> </p><p><span style="font-family: 新細明體,serif;">違反第五十七條第二項或第四項規定者，除依第一項規定處罰外，中央衛生主管機關得公布藥廠或藥商名單，並令其限期改善，改善期間得停止其一部或全部製造、輸入及營業；屆期未改善者，不准展延其藥物許可證，且不受理該製造廠其他藥物之新申請案件；其情節重大者，並得廢止其一部或全部之藥物製造許可。</span> </p><p><span style="font-family: 新細明體,serif;">違反第六十六條第一項、第二項、第六十七條、第六十八條規定之一者，處新臺幣二十萬元以上五百萬元以下罰鍰。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;93&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">違反第十六條第二項、第二十八條、第三十條、第三十二條第一項、第三十三條、第三十七條第一項、第三十八條或第六十二條規定之一，或有左列情形之一者，處新臺幣三萬元以上十五萬元以下罰鍰：</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">一、成藥、固有成方製劑之製造、標示及販售違反中央衛生主管</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: 新細明體,serif;">機關依第八條第三項規定所定辦法。</span> </p><p><span style="font-family: 新細明體,serif;">二、醫療器材之分級及管理違反中央衛生主管機關依第十三條第二項規定所定辦法。</span> </p><p><span style="font-family: 新細明體,serif;">三、藥物樣品、贈品之使用及包裝違反中央衛生主管機關依第五</span><span style="font-family: calibri;">&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">十五條第二項規定所定辦法。</span> </p><p><span style="font-family: 新細明體,serif;">違反第十六條第二項或第三十條規定者，除依前項規定處罰外，衛生主管機關並得停止其營業。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;94&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">違反第三十四條第一項、第七十三條第二項、第八十條第一項第五款至第七款或第二項規定之一者，處新臺幣二萬元以上十萬元以下罰鍰。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp; 95&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">傳播業者違反第六十六條第三項規定者，處新臺幣二十萬元以上五百萬元以下罰鍰，其經衛生主管機關通知限期停止而仍繼續刊播者，處新臺幣六十萬元以上二千五百萬元以下罰鍰，並應按次連續處罰，至其停止刊播為止。</span> </p><p><span style="font-family: 新細明體,serif;">傳播業者違反第六十六條第四項規定者，處新臺幣六萬元以上三十萬元以下罰鍰，並應按次連續處罰。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;96&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">違反第七章規定之藥物廣告，除依本章規定處罰外，衛生主管機關得登報公告其負責人姓名、藥物名稱及所犯情節，情節重大者，並得廢止該藥物許可證；其原品名二年內亦不得申請使用。</span> </p><p><span style="font-family: 新細明體,serif;">前項經廢止藥物許可證之違規藥物廣告，仍應由原核准之衛生主管機關責令該業者限期在原傳播媒體同一時段及相同篇幅刊播，聲明致歉。屆期未刊播者，翌日起停止該業者之全部藥物廣告，並不再受理其廣告之申請。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 96-1 &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">藥商違反第四十八條之一規定者，處新臺幣六萬元以上三十萬元以下罰鍰；其經衛生主管機關通知限期改善而仍未改善者，加倍處罰，並得按次連續處罰，至其改善為止。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;97&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">藥商使用不實資料或證件，辦理申請藥物許可證之查驗登記、展延登記或變更登記時，除撤銷該藥物許可證外，二年內不得申請該藥物許可證之查驗登記；其涉及刑事責任者，並移送司法機關辦理。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 97-1 &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">依藥品查驗登記審查準則及醫療器材查驗登記審查準則提出申請之案件，其送驗藥物經檢驗與申請資料不符者，中央衛生主管機關自檢驗結果確定日起六個月內，不予受理其製造廠其他藥物之新申請案件。</span> </p><p><span style="font-family: 新細明體,serif;">前項情形於申復期間申請重新檢驗仍未通過者，中央衛生主管機關自重新檢驗結果確定日起一年內，不予受理其製造廠其他藥物之新申請案件。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;98&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">（刪除）</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;99&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">依本法規定處罰之罰鍰，受罰人不服時，得於處罰通知送達後十五日內，以書面提出異議，申請復核。但以一次為限。</span> </p><p><span style="font-family: 新細明體,serif;">科處罰鍰機關應於接到前項異議書後十五日內，將該案重行審核，認為有理由者，應變更或撤銷原處罰。</span> </p><p><span style="font-family: 新細明體,serif;">受罰人不服前項復核時，得依法提起訴願及行政訴訟。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 99-1 &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">依本法申請藥物查驗登記、許可證變更、移轉及展延之案件，未獲核准者，申請人得自處分書送達之日起四個月內，敘明理由提出申復。但以一次為限。</span> </p><p><span style="font-family: 新細明體,serif;">中央衛生主管機關對前項申復認有理由者，應變更或撤銷原處分。</span> </p><p><span style="font-family: 新細明體,serif;">申復人不服前項申復決定時，得依法提起訴願及行政訴訟。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;100&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本法所定之罰鍰，由直轄市、縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">衛生主管機關處罰之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;101 &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">依本法應受處罰者，除依本法處罰外，其有犯罪嫌疑者，應移送司法機關處理。</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">十</span> <span style="font-family: 新細明體,serif;">章</span> <span style="font-family: 新細明體,serif;">附則</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;102 &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫師以診療為目的，並具有本法規定之調劑設備者，得依自開處方，親自為藥品之調劑。</span> </p><p><span style="font-family: 新細明體,serif;">全民健康保險實施二年後，前項規定以在中央或直轄市衛生主管機關公告無藥事人員執業之偏遠地區或醫療急迫情形為限。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;103 &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本法公布後，於六十三年五月三十一日前依規定換領中藥販賣業之藥商許可執照有案者，得繼續經營第十五條之中藥販賣業務。</span> </p><p><span style="font-family: 新細明體,serif;">八十二年二月五日前曾經中央衛生主管機關審核，予以列冊登記者，或領有經營中藥證明文件之中藥從業人員，並修習中藥課程達適當標準，得繼續經營中藥販賣業務。</span> </p><p><span style="font-family: 新細明體,serif;">前項中藥販賣業務範圍包括︰中藥材及中藥製劑之輸入、輸出及批發；中藥材及非屬中醫師處方藥品之零售；不含毒劇中藥材或依固有成方調配而成之傳統丸、散、膏、丹、及煎藥。</span> </p><p><span style="font-family: 新細明體,serif;">上述人員、中醫師檢定考試及格或在未設中藥師之前曾聘任中醫師、藥師及藥劑生駐店管理之中藥商期滿三年以上之負責人，經修習中藥課程達適當標準，領有地方衛生主管機關證明文件；並經國家考試及格者，其業務範圍如左︰</span> </p><p><span style="font-family: 新細明體,serif;">一、中藥材及中藥製劑之輸入、輸出及批發。</span> </p><p><span style="font-family: 新細明體,serif;">二、中藥材及非屬中醫師處方藥品之零售。</span> </p><p><span style="font-family: 新細明體,serif;">三、不含毒劇中藥材或依固有成方調配而成之傳統丸、散、膏、丹、及煎藥。</span> </p><p><span style="font-family: 新細明體,serif;">四、中醫師處方藥品之調劑。</span> </p><p><span style="font-family: 新細明體,serif;">前項考試，由考試院會同行政院定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;104 &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">民國七十八年十二月三十一日前業經核准登記領照營業之西藥販賣業者、西藥種商，其所聘請專任管理之藥師或藥劑生免受第二十八條第一項駐店管理之限制。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 104-1 &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">前條所稱民國七十八年十二月三十一日前業經核准登記領照營業之西藥販賣業者、西藥種商，係指其藥商負責人於七十九年一月一日以後，未曾變更且仍繼續營業者。但營業項目登記為零售之藥商，因負責人死亡，而由其配偶為負責人繼續營業者，不在此限。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 104-2 &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">依本法申請證照或事項或函詢藥品查驗登記審查準則及醫療器材查驗登記審查準則等相關規定，應繳納費用。</span> </p><p><span style="font-family: 新細明體,serif;">前項應繳費用種類及其費額，由中央衛生主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 104-3 &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">各級衛生主管機關於必要時，得將藥物抽查及檢驗之一部或全部，委任所屬機關或委託相關機關（構）辦理；其委任、委託及其相關事項之辦法，由中央衛生主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 104-4 &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">中央衛生主管機關得就藥物檢驗業務，辦理檢驗機構之認證；其認證及管理辦法，由中央衛生主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">前項認證工作，得委任所屬機關或委託其他機關（構）辦理；其委任、委託及其相關事項之辦法，由中央衛生主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp; 105 &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">本法施行細則，由中央衛生主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;106 &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">本法自公布日施行。</span> </p><p><span style="font-family: 新細明體,serif;">本法中華民國八十六年五月七日修正公布之第五十三條施行日期，由行政院定之；中華民國九十五年五月五日修正之條文，自中華民國九十五年七月一日施行。</span> </p> 2013-12-05 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=1027&type=0;;https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=1042&type=0;;https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6047&type=0
1420547 藥政管理類,藥事法施行細則 法規命令 藥事法施行細則 <p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 1 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;">&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">本細則依藥事法</span><span style="font-size: 14pt; font-family: calibri;"> (</span><span style="font-size: 14pt; font-family: 新細明體,serif;">以下簡稱本法</span><span style="font-size: 14pt; font-family: calibri;">) </span><span style="font-size: 14pt; font-family: 新細明體,serif;">第一百零五條規定訂定之。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 2 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;">&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">本法第七條，用詞定義如下：</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">一、新成分：指新發明之成分可供藥用者。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">二、新療效複方：指已核准藥品具有新適應症、降低副作用、改善療效強度、改善療效時間或改變使用劑量之新醫療效能，或二種以上已核准成分之複方製劑具有優於各該單一成分藥品之醫療效能者。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">三、新使用途徑：指已核准藥品改變其使用途徑者。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 3 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;">&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">本法第八條第二項所稱醫師處方藥品，係指經中央衛生主管機關審定，在藥品許可證上，載明須由醫師處方或限由醫師使用者。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 4 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;">&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">本法所稱稽查，係指關於藥物有無經核准查驗登記及與原核准查驗登記或規定是否相符之檢查事項。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">本法所稱檢驗，係指關於藥品之性狀、成分、質、量或強度等化驗鑑定事項，或醫療器材之化學、物理、機械、材質等鑑定事項。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 5 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;">&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">本法第二十條第一款所稱未經核准，擅自製造者，不包括非販賣之研究、試製之藥品。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">前項藥品應備有研究或試製紀錄，並以無商品化之包裝者為限。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 6 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;">&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">本法第二十二條第二款所稱未經核准擅自輸入之藥品，係指該藥品未曾由中央衛生主管機關依本法第三十九條規定核發輸入許可證者。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 7 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;">&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">本法第二十三條第一款所稱使用，係指依標籤或仿單刊載之用法，作正常合理之使用者。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 8 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;">&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">本法第二十五條所稱標籤，包括直接標示於醫療器材上之文字、圖畫或記號。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 9 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;">&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">本法第二十七條第二項規定藥商登記事項如左：</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">一、藥商種類。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">二、營業項目。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">三、藥商名稱。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">四、地址。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">五、負責人。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">六、藥物管理、監製或技術人員。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">七、其他應行登記事項。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 10 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;">&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">依本法第二十七條第一項規定申請藥商登記者，應填具申請書，連同執照費及下列文件，申請直轄市或縣（市）衛生主管機關核准：</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">一、依本法規定，應聘用藥物管理、監製或技術人員者，其所聘人員之執</span><span style="font-size: 14pt;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">業執照或證明文件。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">二、藥商為公司組織者，其公司登記、公司組織章程影本。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">三、藥物販賣業者，其營業地址、場所（貯存藥品倉庫）及主要設備之平面略圖。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">四、藥物製造業者，其工廠登記證明文件及其影本。但依工廠管理輔導法規定免辦理工廠登記者，免附。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">五、直轄市或縣（市）衛生主管機關所定之其他文件。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">新設立公司組織之藥商，得由衛生主管機關先發給籌設許可文件，俟取得公司登記或工廠登記證明文件後，再核發藥商許可執照。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 11 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;">&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">申請藥商登記者，其藥商種類及應載明之營業項目，應依本法第十四條至第十八條之規定。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">西藥販賣業者，由藥劑生駐店管理時，其營業項目應加註不販賣麻醉藥品。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">藥商經營醫用放射性藥品者，應依有關法令規定，申請核准後始得販賣。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 12 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;">&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">藥品製造業者依本法第十六條規定在其製造加工之同一處所經營自製產品之批發、輸出、自用原料輸入及兼營自製產品之零售業務者，得由其監製人兼為管理之。但兼營非本藥商產品之販賣業務或分設處所經營各該業務者，應分別聘管理人員，並辦理藥品販賣業之藥商登記。</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">藥品製造業者依本法第五十八條規定，委託他廠製造之產品，其批發、</span><span style="font-size: 14pt;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">輸出及零售，得依前項前段規定辦理。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 13 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;">&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">醫療器材製造業者依本法第三十二條規定應聘技術人員之醫療器材類別及其技術人員資格，依左列規定：</span> </p><p><span style="font-size: 14pt;"><span style="font-family: calibri;">一、</span><span style="font: 7pt times new roman;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></span><span style="font-size: 14pt; font-family: 新細明體,serif;">製造一般醫療設備、臨床檢驗設備及生物材料設備者，應聘國內公立或立案之私立專科以上學校或經教育部承認之國外專科以上學校理、工、醫、農等相關科、系、所畢業之專任技術人員駐廠監製。</span> </p><p><span style="font-size: 14pt;"><span style="font-family: calibri;">二、</span><span style="font: 7pt times new roman;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></span><span style="font-size: 14pt; font-family: 新細明體,serif;">製造隱形眼鏡鏡片消毒藥水</span><span style="font-size: 14pt; font-family: calibri;"> (</span><span style="font-size: 14pt; font-family: 新細明體,serif;">錠</span><span style="font-size: 14pt; font-family: calibri;">) </span><span style="font-size: 14pt; font-family: 新細明體,serif;">、移植器官保存液、衛生材料、衛生棉條業者，應聘專任藥師駐廠監製。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 14 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;">&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">藥商許可執照、藥局執照，應懸掛於營業處所之明顯位</span><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">置。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 15 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;">&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">本法第二十七條第一項所稱應辦理變更登記之事項，包括</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">藥商登記事項之變更及自行停業、復業或歇業。</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">前項應辦理變更登記事項，藥商應自事實發生之日起十五</span><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp; </span></p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">日內，向原核准登記之衛生主管機關申請辦理變更登記。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 16 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;">&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">藥商辦理變更登記，除遷址變更登記，應先向衛生主管機</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">關申請辦理外，其他公司組織或商業登記事項之變更，應</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">先向商業主管機關辦妥各該變更登記。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 17 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;">&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">藥商依本法第二十八條或第二十九條規定聘用之管理或</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">監製人員，或第三十一條、第三十二條規定聘用之技術人</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">員，因解聘、辭聘或其他原因不能執行其任務而未另行聘</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">置時，應即停止營業，並申請停業或歇業之登記。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 18 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;">&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">藥品販賣業者依本法第二十八條規定聘用之藥師、藥劑生</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">或中醫師，或本法第十九條規定親自主持藥局業務之藥</span><span style="font-size: 14pt; font-family: calibri;">&nbsp; </span></p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">師、藥劑生，均應親自在營業場所執行業務，其不在場時，</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">應於門口懸掛明顯標示。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 19 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條（刪除）</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 20 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條（刪除）</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 21 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條（刪除）</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 22 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條（刪除）</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 22-1 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;">&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">依本法第三十九條第二項規定申請輸入試製藥品原料</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">藥者，應繳納費用，並填具申請書及檢附下列資料，送</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">請中央衛生主管機關核辦：</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;</span><span style="font-size: 14pt; font-family: 新細明體,serif;">一、藥商許可執照。</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;</span><span style="font-size: 14pt; font-family: 新細明體,serif;">二、試製計畫書。</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;</span><span style="font-size: 14pt; font-family: 新細明體,serif;">三、經濟部工廠登記證明文件。但研發單位，免附。</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;</span><span style="font-size: 14pt; font-family: 新細明體,serif;">四、委託其他藥商辦理輸入試製藥品原料藥者，其委託</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">書、委託者及受委託者之藥商許可執照。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 23 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條（刪除）</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 23-1 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;">&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">中央衛生主管機關對於藥物之查驗，得委託衛生財團法</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">人或其他相關團體、機構辦理學術性研究、安全、臨床</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">試驗等技術性資料之審查業務。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 24 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;">&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">本法第三十九條、第四十條所稱藥物查驗登記事項如左：</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">一、藥物中文及外文品名。</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">二、藥品處方及藥品劑型。</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">三、醫療器材成分、材料、結構及規格。</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">四、藥物標籤、仿單及包裝。</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">五、藥品之直接包裝。</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">六、適應症、效能、性能、用法、用量及類別。</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">七、藥物製造方法、檢驗規格及檢驗方法。</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">八、藥商名稱。</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">九、製造廠廠名及廠址。</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">一○、其他經中央衛生主管機關指定登記事項。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 25 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條（刪除）</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 26 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條（刪除）</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 27 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;">&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">國內製造之藥物，其標籤、仿單、包裝應以中文為主，所</span><span style="font-size: 14pt; font-family: calibri;">&nbsp; </span></p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">附外文文字應小於中文。</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">國外輸入之藥物，除應加附中文仿單外，其標籤、包裝均</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">應另以中文載明品名、類別、許可證字號及輸入藥商名</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">稱、地址，且應以中文或依習慣能辨明之方式刊載有效期</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">間或保存期限；其中文品名之文字不得小於外文。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 28 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;">&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">藥商名稱之變更，涉及權利之移轉者，應由雙方共同提出</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">申請。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 29 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條（刪除）</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 30 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條（刪除）</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 31 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;">&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">輸出藥物為應輸出地區購買者之要求，須變更藥物名稱、</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">標籤、仿單、包裝或附加外文者，應檢附其所變更之實樣</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">各二份，申請中央衛生主管機關核定。</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">前項經變更名稱、標籤、仿單、包裝或附加外文之藥物，</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">不得用於內銷。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 32 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條（刪除）</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 33 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;">&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">本法第四十九條所稱不得買賣，包括不得將藥物供應非藥</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">局、非藥商及非醫療機構。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 34 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;">&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">依本法第五十三條第二項為輸入原料藥之分裝，應由輸入</span><span style="font-size: 14pt; font-family: calibri;">&nbsp; </span></p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">之藥商於符合優良藥品製造規範之藥廠分裝後，填具申請</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">書，連同藥品許可證影本、海關核發之進口報單副本、原</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">廠檢驗成績書、檢驗方法及其他指定文件，申請中央衛生</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">主管機關備查。</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">經分裝之原料藥，以銷售藥品製造業者為限；所使用之標</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">籤應分別刊載左列事項：</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">一、廠商名稱及地址。</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">二、品名及許可證字號。</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">三、效能或適應症。</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">四、批號。</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">五、分裝藥商名稱及地址。</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">六、分裝日期。</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">七、製造日期及有效期間或保存期限。</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">八、其他依規定應刊載事項。</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">前項第七款經中央衛生主管機關明令公告免刊載者，不在</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">此限。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 35 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;">&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">生物藥品之容器、標籤、仿單及包裝，除應依本法第七十</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">五條規定刊載外，含有防腐劑者，應標明防腐劑含量。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 36 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;">&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">依本法第七十四條所規定辦理之藥品檢驗封緘，其審查或</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">檢驗結果為不合格者，國外輸入藥品應由直轄市或縣</span><span style="font-size: 14pt; font-family: calibri;"> (</span><span style="font-size: 14pt; font-family: 新細明體,serif;">市</span><span style="font-size: 14pt; font-family: calibri;">) </span></p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">衛生主管機關派員監督原輸入藥商限期退運；本國製造藥</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">品可改製使用者，由直轄市或縣</span><span style="font-size: 14pt; font-family: calibri;">(</span><span style="font-size: 14pt; font-family: 新細明體,serif;">市</span><span style="font-size: 14pt; font-family: calibri;">) </span><span style="font-size: 14pt; font-family: 新細明體,serif;">衛生主管機關派員監</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">督原製造廠商限期改製。屆期未能退運或改製，或不能改</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">製者，應予以銷燬。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 37 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;">&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">藥物有本法第八十條第一項第一款至第四款所列情形之</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">一者，藥商、藥局及醫療機構，應自公告或依法認定之日</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">起，立即停止輸入、製造、批發、陳列、調劑、零售；其</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">製造或輸入之業者，並應於回收期限內回收市售品，連同</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">庫存品依本法第七十九條規定處理；回收期限由中央衛生</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">主管機關依個案性質決定，最長不得超過二個月。</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">藥物有本法第八十條第一項第五款或第六款情形之一</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">者，其製造或輸入之業者，應自藥物許可證到期或包裝、</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">標籤、仿單經核准變更之日起六個月內收回市售品，連同</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">庫存品送經直轄市或縣（市）衛生主管機關驗章後，始得</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">販賣。</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">製造或輸入業者執行藥物回收作業前，應訂定回收作業計</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">畫書，載明回收程序、回收期限、執行成果報告書報備之</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">期限及其他相關事項報中央衛生主管機關備查後，依該計</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">畫書執行；並於執行結束後，製作回收報告書，報各級衛</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">生主管機關備查。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 38 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;">&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">取締偽藥、劣藥、禁藥、不良醫療器材及未經許可製造或</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">輸入之醫療器材，直轄市衛生主管機關得設置查緝中心；</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">縣</span><span style="font-size: 14pt; font-family: calibri;"> (</span><span style="font-size: 14pt; font-family: 新細明體,serif;">市</span><span style="font-size: 14pt; font-family: calibri;">) </span><span style="font-size: 14pt; font-family: 新細明體,serif;">衛生主管機關得設置查緝小組。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 39 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;">&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">舉發偽藥、劣藥、禁藥、不良醫療器材或未經核准製造或</span><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp; </span></p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">輸入之醫療器材經緝獲者，應由直轄市或縣</span><span style="font-size: 14pt; font-family: calibri;"> (</span><span style="font-size: 14pt; font-family: 新細明體,serif;">市</span><span style="font-size: 14pt; font-family: calibri;">) </span><span style="font-size: 14pt; font-family: 新細明體,serif;">衛生主</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">管機關依左列標準計點核發獎金：</span> </p><p><span style="font-size: 14pt;"><span style="font-family: calibri;">一、</span><span style="font: 7pt times new roman;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></span><span style="font-size: 14pt; font-family: 新細明體,serif;">舉發製造或輸入偽藥、禁藥或未經核准製造或輸入醫療器材</span><span style="font-size: 14pt; font-family: calibri;">&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">者：四至十點。</span> </p><p><span style="font-size: 14pt;"><span style="font-family: calibri;">二、</span><span style="font: 7pt times new roman;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></span><span style="font-size: 14pt; font-family: 新細明體,serif;">舉發以批發方式轉售</span><span style="font-size: 14pt; font-family: calibri;"> (</span><span style="font-size: 14pt; font-family: 新細明體,serif;">讓</span><span style="font-size: 14pt; font-family: calibri;">) </span><span style="font-size: 14pt; font-family: 新細明體,serif;">偽藥、禁藥或未經核准製造或輸入醫療器材者：二至五點。</span> </p><p><span style="font-size: 14pt;"><span style="font-family: calibri;">三、</span><span style="font: 7pt times new roman;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></span><span style="font-size: 14pt; font-family: 新細明體,serif;">舉發零售、運送、儲</span><span style="font-size: 14pt; font-family: calibri;"> (</span><span style="font-size: 14pt; font-family: 新細明體,serif;">寄</span><span style="font-size: 14pt; font-family: calibri;">) </span><span style="font-size: 14pt; font-family: 新細明體,serif;">藏、牙保或意圖販賣而陳列偽藥、禁藥或未經核准製造或輸入醫療器材者：二至三點。</span> </p><p><span style="font-size: 14pt;"><span style="font-family: calibri;">四、</span><span style="font: 7pt times new roman;">&nbsp;&nbsp;&nbsp;&nbsp; </span></span><span style="font-size: 14pt; font-family: 新細明體,serif;">舉發製造、輸入、販賣劣藥或不良醫療器材者：二至</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">三點。</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">每點獎金之數額，由直轄市或縣</span><span style="font-size: 14pt; font-family: calibri;"> (</span><span style="font-size: 14pt; font-family: 新細明體,serif;">市</span><span style="font-size: 14pt; font-family: calibri;">) </span><span style="font-size: 14pt; font-family: 新細明體,serif;">衛生主管機關視情</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">況訂定，並編列預算支應之。中央衛生主管機關於必要時，</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">得編列緝獲獎金補助之。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 40 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;">&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">二人以上聯名舉發前條之案件，其獎金應由原舉發人聯名</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">具領。二人以上分別舉發案件而有相同部分者，其獎金應</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">發給最先舉發者；如無法分別先後時，平均分發之。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 41 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;">&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">協助查緝機關緝獲偽藥、劣藥、禁藥、不良醫療器材及未</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">經核准製造或輸入之醫療器材者，其獎勵準用關於舉發人</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">之規定。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 42 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;">&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">依本細則應發給獎金者，應由緝獲偽藥、劣藥、禁藥、不</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">良醫療器材及未經核准製造或輸入醫療器材之機關敘明</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">事實申請之。但同時符合</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">本細則或其他法令規定給予獎勵者，不得重複給獎。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 43 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;">&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">對於舉發人或協助緝獲偽藥、劣藥、禁藥、不良醫療器材</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">及未經核准製造或輸入醫療器材者之姓名，應嚴予保密，</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">不得洩漏。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 44 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;">&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">登載或宣播藥物廣告，應由領有藥物許可證之藥商，填具</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">申請書，連同藥物許可證影本、核定之標籤、仿單或包裝</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">影本、廣告內容及審查費，申請中央或直轄市衛生主管機</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">關核准後為之。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 45 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;">&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">藥物廣告所用之文字圖畫，應以中央衛生主管機關所核定</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">之藥物名稱、劑型、處方內容、用量、用法、效能、注意</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">事項、包裝及廠商名稱、地址為限。</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">中藥材之廣告所用文字，其效能應以本草綱目所載者為</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">限。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 46 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;">&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">藥物廣告應將廠商名稱、藥物許可證及廣告核准文件字</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">號，一併登載或宣播。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 47 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;">&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">藥物廣告之內容，具有左列情形之一者，應予刪除或不予</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">核准：</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">一、涉及性方面之效能者。</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">二、利用容器包裝換獎或使用獎勵方法，有助長濫用藥物</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">之虞者。</span> </p><p><span style="font-size: 14pt;"><span style="font-family: calibri;">三、</span><span style="font: 7pt times new roman;">&nbsp;&nbsp;&nbsp;&nbsp; </span></span><span style="font-size: 14pt; font-family: 新細明體,serif;">表示使用該藥物而治癒某種疾病或改進某方面體質</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">及健康或捏造虛偽情事藉以宣揚藥物者。</span> </p><p><span style="font-size: 14pt;"><span style="font-family: calibri;">四、</span><span style="font: 7pt times new roman;">&nbsp;&nbsp;&nbsp;&nbsp; </span></span><span style="font-size: 14pt; font-family: 新細明體,serif;">誇張藥物效能及安全性者。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 48 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條（刪除）</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 49 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條（刪除）</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 50 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;">&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">本法第一百零二條第二項所稱醫療急迫情形，係指醫師於</span> </p><p><span style="font-size: 14pt; font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">醫療機構為急迫醫療處置，須立即使用藥品之情況。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 51 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條（刪除）</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 52 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條（刪除）</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 53 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;">&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">本法及本細則所定文書格式，由中央衛生主管機關定之。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 54 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;">&nbsp; </span><span style="font-size: 14pt; font-family: 新細明體,serif;">本細則自發布日施行。</span> </p> 2013-12-05 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6068&type=0
1420548 藥政管理類,藥物回收作業實施要點 行政解釋 藥物回收作業實施要點 <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 20pt;">藥物回收作業實施要點 </span></p><p style="text-align: center;">&nbsp;</p><p style="line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">一、<span style="font: 7pt times new roman;">&nbsp; </span></span><span style="font-family: 標楷體; color: black; font-size: 14pt;">中央衛生主管機關為維護人民健康及確保合法藥物的品質與安全，並有利藥物回收作業之進行，彙集藥物回收相關規定，訂定本要點。 </span></p><p style="line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">二、<span style="font: 7pt times new roman;">&nbsp; </span></span><span style="font-family: 標楷體; color: black; font-size: 14pt;">藥物製造或輸入業者有事實足認其提供之藥物有危害使用者安全、健康或其他權益之虞時，應依本要點回收市售品，醫療機構、藥局及藥商應予配合，中央、直轄市及縣（市）衛生主管機關並應督導回收作業之執行。 </span></p><p style="line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">三、<span style="font: 7pt times new roman;">&nbsp; </span></span><span style="font-family: 標楷體; color: black; font-size: 14pt;">回收藥物之危害程度，分為下列三級： </span></p><p style="line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">（一） </span><span style="font-family: 標楷體; color: black; font-size: 14pt;">第一級危害：指藥物有下列情形之一者： </span></p><p style="line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">1. </span><span style="font-family: 標楷體; color: black; font-size: 14pt;">屬藥事法第八十條第一項第一款所指之藥物。</span> </p><p style="line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">2. </span><span style="font-family: 標楷體; color: black; font-size: 14pt;">依消費者保護法第三十三條及三十八條規定，許可製造、輸入之藥物經認定有發生重大損害之虞者。 </span></p><p style="line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">3. </span><span style="font-family: 標楷體; color: black; font-size: 14pt;">劣藥、不良醫療器材或藥事法第八十條第一項第四款所指之藥物，且有發生重大損害之虞者。</span> </p><p style="line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">4. </span><span style="font-family: 標楷體; color: black; font-size: 14pt;">偽藥、禁藥或未經核准而製造、輸入之醫療器材。 </span></p><p style="line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">（二） </span><span style="font-family: 標楷體; color: black; font-size: 14pt;">第二級危害：指藥物有下列情形之一者： </span></p><p style="line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">1. </span><span style="font-family: 標楷體; color: black; font-size: 14pt;">劣藥、不良醫療器材或藥事法第八十條第一項第四款所指之藥物，但無發生重大損害之虞者。</span> </p><p style="line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">2. </span><span style="font-family: 標楷體; color: black; font-size: 14pt;">依消費者保護法第三十三條及第三十八條規定，許可製造、輸入之藥物經認定有發生非重大損害之虞者。 </span></p><p style="line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">（三） </span><span style="font-family: 標楷體; color: black; font-size: 14pt;">第三級危害：指藥物有損害使用者安全、健康或其他權益之虞，而非屬第一級或第二級危害者。 </span></p><p style="line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">四、<span style="font: 7pt times new roman;">&nbsp;&nbsp;&nbsp; </span></span><span style="font-family: 標楷體; color: black; font-size: 14pt;">各級危害藥物之回收處置方法： </span></p><p style="line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">（一） </span><span style="font-family: 標楷體; color: black; font-size: 14pt;">第一級危害及第二級危害：中央、直轄市或縣（市）衛生主管機關應命藥物製造或輸入之業者依規定期限內回收市售品。 </span></p><p style="line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">（二） </span><span style="font-family: 標楷體; color: black; font-size: 14pt;">第三級危害：中央、直轄市或縣（市）衛生主管機關得建議藥物製造或輸入之業者自衛生主管機關通知之日起六個月內回收市售品。 </span></p><p style="line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">為掌握藥物回收訊息，各級衛生主管機關為前項處置時，應相互通報。 </span></p><p style="line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">屬第一級危害者，直轄市或縣(市)衛生主管機關應於各級衛生主管機關通知業者執行回收作業後十日內，至相關醫療機構、藥局及藥商進行抽查，確認危害藥物確實下架。 </span></p><p style="line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">五、<span style="font: 7pt times new roman;">&nbsp; </span></span><span style="font-family: 標楷體; color: black; font-size: 14pt;">中央、直轄市或縣（市）衛生主管機關得於機關網站公布藥物回收相關資訊，如經發現為第一級危害者，並得於大眾傳播媒體公布之。 </span></p><p style="line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">六、<span style="font: 7pt times new roman;">&nbsp; </span></span><span style="font-family: 標楷體; color: black; font-size: 14pt;">中央、直轄市或縣（市）衛生主管機關得依消費者保護法第三十六條及第三十八條、消費者保護法施行細則第三十四條及</span><span style="font-family: 標楷體; color: black; font-size: 14pt;">藥物製造工廠設廠標準</span><span style="font-family: 標楷體; color: black; font-size: 14pt;">相關規定，要求藥物製造或輸入業者依下列程序辦理藥物回收作業： </span></p><p style="line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">（一）</span><span style="font-family: 標楷體; color: black; font-size: 14pt;">平時應建立回收作業程序及確實完整的運銷紀錄（內容包括產品之名稱、含量、劑型、批號，受貨者之名稱、地址、出廠日期及數量），作為回收作業之依據。 </span></p><p style="line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">（二）</span><span style="font-family: 標楷體; color: black; font-size: 14pt;">執行危害藥物之回收作業時，應訂定回收作業計畫書，其內容包括下列各項資料： </span></p><p style="line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">1. </span><span style="font-family: 標楷體; color: black; font-size: 14pt;">藥物之品名、規格及藥物許可證字號。 </span></p><p style="line-height: 20pt;"><span style="font-family: 標楷體; font-size: 14pt;">2. </span><span style="font-family: 標楷體; font-size: 14pt;">藥物之批號或序號等識別資料與編號。 </span></p><p style="line-height: 20pt;"><span style="font-family: 標楷體; font-size: 14pt;">3. </span><span style="font-family: 標楷體; color: black; font-size: 14pt;">回收藥物於國內、外之銷售對象及其銷售數量，以及總銷售數量。</span> </p><p style="line-height: 20pt;"><span style="font-family: 標楷體; font-size: 14pt;">4. </span><span style="font-family: 標楷體; font-size: 14pt;">藥物回收之原因及其可能產生之危險。 </span></p><p style="line-height: 20pt;"><span style="font-family: 標楷體; font-size: 14pt;">5. </span><span style="font-family: 標楷體; color: black; font-size: 14pt;">通知該藥物供應者之方式及內容，以及其他</span><span style="font-family: 標楷體; color: black; font-size: 14pt;">擬採取之相關動作</span><span style="font-family: 標楷體; color: black; font-size: 14pt;">。</span> </p><p style="line-height: 20pt;"><span style="font-family: 標楷體; font-size: 14pt;">（三）</span><span style="font-family: 標楷體; color: black; font-size: 14pt;">將回收作業計畫書通報下命回收之衛生主管機關，若下命機關為</span><span style="font-family: 標楷體; color: black; font-size: 14pt;">直轄市或縣（市）衛生主管機關者，則應副知中央衛生主管機關</span><span style="font-family: 標楷體; color: black; font-size: 14pt;">。回收作業若屬業者發動者，亦同。</span> </p><p style="line-height: 20pt;"><span style="font-family: 標楷體; font-size: 14pt;">（四）</span><span style="font-family: 標楷體; color: black; font-size: 14pt;">依據運銷紀錄及回收作業計畫書進行危害藥物之回收，並立即通知醫療機構、藥局及藥商，且留紀錄備查。</span> </p><p style="line-height: 20pt;"><span style="font-family: 標楷體; font-size: 14pt;">（五）</span><span style="font-family: 標楷體; color: black; font-size: 14pt;">已回收的產品於決定最終處置方式前，應予識別與標示並分別儲存。</span> </p><p style="line-height: 20pt;"><span style="font-family: 標楷體; font-size: 14pt;">（六）</span><span style="font-family: 標楷體; color: black; font-size: 14pt;">依回收作業計畫書執行完畢者，應將其處理過程及結果，完成回收報告書，並於回收期限內函報中央及所轄地方衛生主管機關。</span> </p><p style="line-height: 20pt;"><span style="font-family: 標楷體; font-size: 14pt;">（七）</span><span style="font-family: 標楷體; color: black; font-size: 14pt;">回收報告書內容應包括下列各項資料：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">1. </span><span style="font-family: 標楷體; color: black; font-size: 14pt;">藥物之品名、規格及藥物許可證字號。　 </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">2. </span><span style="font-family: 標楷體; color: black; font-size: 14pt;">藥物之批號或序號等識別資料與編號。 </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">3. </span><span style="font-family: 標楷體; color: black; font-size: 14pt;">銷售總數量及實際回收總數量。 </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">4. </span><span style="font-family: 標楷體; color: black; font-size: 14pt;">市售品及庫存品回收完畢日期，及其後續處置方式及處置日期。如已銷燬者，並檢附銷燬過程之拍照或錄影紀錄。 </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">5. </span><span style="font-family: 標楷體; color: black; font-size: 14pt;">回收事件分析，包括品質缺失情形之發生原因及預防矯正措施。 </span></p><p style="line-height: 20pt;"><span style="font-family: 標楷體; font-size: 14pt;">七、<span style="font: 7pt times new roman;">&nbsp; </span></span><span style="font-family: 標楷體; color: black; font-size: 14pt;">直轄市或縣（市）衛生主管機關應確認業者對於收回之市售品及庫存品後續之處置方法及結果。</span> </p><p style="line-height: 20pt;"><s><span style="font-family: 標楷體; color: blue; font-size: 14pt; text-decoration: none;">&nbsp;</span></s></p> 2013-12-05
1420549 藥政管理類,藥物安全監視管理辦法 法規命令 藥物安全監視管理辦法 <p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 1&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本辦法依藥事法第四十五條第二項規定訂定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 2&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本辦法適用範圍如下：</span> </p><p><span style="font-family: 新細明體,serif;">一、藥事法第七條所稱之新藥。</span> </p><p><span style="font-family: 新細明體,serif;">二、經行政院衛生署</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">以下簡稱本署</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">公告指定之醫療器材。</span> </p><p><span style="font-family: 新細明體,serif;">三、其他經本署公告認定適用者。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 3&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">經查驗登記審核通過發證之新藥，其安全監視期間自發證日起五年。</span> </p><p><span style="font-family: 新細明體,serif;">前條第二款之監視期間，自發證日起三年。</span> </p><p><span style="font-family: 新細明體,serif;">前條第三款之監視期間，依本署之規定。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 4&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">藥物安全監視期間，持有藥物許可證之藥商應積極收集國內、外藥物使用之安全資料，除依嚴重藥物不良反應通報辦法之規定為通報外，其他藥物不良反應須一併收錄，並列於藥物定期安全性報告內，依本署指定時間通報之。</span> </p><p><span style="font-family: 新細明體,serif;">藥商未依前項規定進行通報者，本署得重新評估其安全性。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 5&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">於國內完成臨床試驗或銜接性試驗並經本署核准之新藥，其新藥安全監視期間，各醫療院所不得再要求個別之進藥臨床試驗或試用。但以驗收為目的之產品化驗，不在此限。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 6&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本辦法自發布日施行。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: calibri;">&nbsp;</span></p> 2013-12-05 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6069&type=0
1420550 化學製造管制類,藥物製造/委託製造,藥物委託製造及檢驗作業準則 法規命令 藥物委託製造及檢驗作業準則 <p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">一</span> <span style="font-family: 新細明體,serif;">章</span> <span style="font-family: 新細明體,serif;">總則</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp; 1&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本準則依藥事法</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">以下簡稱本法</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">第四十二條第二項規定訂定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp; 2&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">藥物之委託製造及檢驗，應依本準則之規定；本準則未規定者，適用其他有關法令之規定。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp; 3&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本準則所稱委託製造，係指將藥物在製程中之任一階段或連續階段或全程委託他廠製造。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp; 4&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本準則所稱委託檢驗，係指將藥物技術層面之研究發展、製程中之管制作業及原物料、半製品或產品之品質管制與安定性試驗等項目，委託他廠或相關單位執行。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp; 5&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">委託製造或檢驗藥物，應事先申請中央衛生主管機關核准。</span> </p><p><span style="font-family: 新細明體,serif;">申請藥物委託製造及檢驗，限持有藥物許可證或申請藥物查驗登記之藥商。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp; 6&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">經核准委託製造或檢驗之藥物，除法律另有規定外，其產品責任由委託者負責。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp; 7&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">委託製造或檢驗契約有效期間屆滿不再續約或因故中途解約，或變更委託檢驗項目時，委託者應先覓妥其他受託廠或相關單位，重新依規定申請委託製造或檢驗。</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">二</span> <span style="font-family: 新細明體,serif;">章</span> <span style="font-family: 新細明體,serif;">藥物之委託製造</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp; 8&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">受託製造廠，應為符合藥物製造工廠設廠標準第三編</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">以下簡稱藥品優良製造規範</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">或第四編</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">以下簡稱醫療器材優良製造規範</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">規定之藥物工廠。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp; 9&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">委託製造者應先覓妥受託廠，並填具申請書及檢附雙方簽立之委託製造契約等相關文件，向中央衛生主管機關申請核准。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 10&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">經核准委託製造之藥物，其標籤及包裝，除應符合本法及有關法令規定外，並應刊載受託廠及委託者之名稱、地址。但受託廠之名稱、地址，經中央衛生主管機關核准者，得以刊載其所在國別替代之。</span> </p><p><span style="font-family: 新細明體,serif;">前項藥物之仿單，除應符合本法及有關法令規定外，並應分別標示製造廠及委託者之字樣，包括受託廠及委託者之名稱、地址。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 11&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">經核准委託製造之藥物，其許可證有效期間之展延，應由許可證持有者依本法及有關法令規定辦理。</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">三</span> <span style="font-family: 新細明體,serif;">章</span> <span style="font-family: 新細明體,serif;">藥物之委託檢驗</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 12&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">符合下列規定之一者，得接受委託檢驗藥物：</span> </p><p><span style="font-family: 新細明體,serif;">一、符合藥品優良製造規範之藥廠。</span> </p><p><span style="font-family: 新細明體,serif;">二、符合醫療器材優良製造規範之醫療器材廠。</span> </p><p><span style="font-family: 新細明體,serif;">三、符合非臨床試驗優良操作規範規定之國內外學術研究機構。</span> </p><p><span style="font-family: 新細明體,serif;">四、其他經中央衛生主管機關專案核准者。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 13&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">委託者與受託者應訂立委託檢驗契約，列明其委託檢驗範圍之相關事項、作業計畫書及標準作業程序。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 14&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">委託者應先覓妥受託檢驗者，並填具申請書及檢附雙方簽立之委託檢驗契約等相關文件，向中央衛生主管機關申請核准。</span> </p><p><span style="font-family: 新細明體,serif;">中央衛生主管機關得視實際需要，對受託者進行現場查核。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 15&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">經核准之委託檢驗，委託者應檢附依檢驗所需二倍以上數量之檢體，送交受託者檢驗；其驗餘完整包裝之檢體，由受託者封緘後，交還委託者自行保存。</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">四</span> <span style="font-family: 新細明體,serif;">章</span> <span style="font-family: 新細明體,serif;">附則</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 16&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本準則自發布日施行。</span> </p> 2013-12-05 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6071&type=0
1420551 藥政管理類,藥物科技研究發展獎勵辦法 法規命令 藥物科技研究發展獎勵辦法 <p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp; 1&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本辦法依藥事法第四十一條第二項規定訂定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp; 2&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本辦法所稱藥物，指藥事法所稱之藥品及醫療器材。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp; 3&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本辦法適用餐獎勵對象為國內之藥物製造廠及從事藥物研發之自然人、法人、機構或團體，其研發成果符合本辦法之獎勵條件者。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp; 4&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本辦法適用之獎勵條件如下：</span> </p><p><span style="font-family: 新細明體,serif;">一、國內自行研發，取得國內</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">外</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">專利，在我國或其他先進國家首先上市之新發明藥物者。</span> </p><p><span style="font-family: 新細明體,serif;">二、取得國內</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">外</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">專利之授權，在國內研發，所生產製品為我國或其他先進國家首先核准或上市之新發明藥物者。</span> </p><p><span style="font-family: 新細明體,serif;">三、國內研發之未上市藥物，取得國內</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">外</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">專利或授權，且經核准在國內</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">外</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">進行臨床試驗研究，有具體成效者。</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">人體試驗階段一、階段二或階段三，各階段得分別提出申請獎勵</span><span style="font-family: calibri;">)</span></p><p><span style="font-family: 新細明體,serif;">四、國內研發或製造藥物，有重要且具體之市場成效者。</span> </p><p><span style="font-family: 新細明體,serif;">五、國內研發或製造藥物以進步性，取得國內外專利，且對藥物製造工業發展有具體貢獻者。</span> </p><p><span style="font-family: 新細明體,serif;">六、國內研發或製造之新原料藥、賦形劑、醫療器材材質、零組件或其他方式，對提昇我國藥物製造工業有顯著貢獻者。</span> </p><p><span style="font-family: 新細明體,serif;">七、引進國外先進科技，於國內研究並產製生物製劑藥品，對國人疾病之醫療有顯著貢獻者。</span> </p><p><span style="font-family: 新細明體,serif;">八、國內自行開發新設備裝置、製程或分析檢驗方法，對改進藥物製造或檢驗技術有重大成效者。</span> </p><p><span style="font-family: 新細明體,serif;">九、配合中央衛生或工業主管機關政策，推動本國藥物製造工業發展，提昇藥物研發水準，績效卓著者。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp; 5&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">為審議依本辦法申請獎勵之案件，應組成藥物研發審議委員會</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">以下簡稱審議會</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">。</span> </p><p><span style="font-family: 新細明體,serif;">審議會置委員九人至十三人，由行政院衛生署及經濟部工業局就行政院衛生署、經濟部工業局、科技相關代表、學術機構、工業界之代表及有關學者共同遴選組成。</span> </p><p><span style="font-family: 新細明體,serif;">審議會由委員相互推選一人為主席。</span> </p><p><span style="font-family: 新細明體,serif;">審議會委員均為無給職。</span> </p><p><span style="font-family: 新細明體,serif;">審議會之任務如下：</span> </p><p><span style="font-family: 新細明體,serif;">一、審查獎勵對象之資格。</span> </p><p><span style="font-family: 新細明體,serif;">二、審議各項獎勵申請案件。</span> </p><p><span style="font-family: 新細明體,serif;">三、核定獎勵名額及核給獎勵點數。</span> </p><p><span style="font-family: 新細明體,serif;">四、其他依本辦法應經審議會審議之事項。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp; 6&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">依本辦法申請獎勵之案件，應由審議會審議通過後，再由中央衛生主管機關會同中央工業主管機關獎勵之。</span> </p><p><span style="font-family: 新細明體,serif;">前項之申請審議，每年辦理一次。必要時得增加辦理次數。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp; 7&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">符合本辦法第四條規定，並經審議會審議通過之受獎勵者，得頒給藥物貢獻獎座一座及獎金，獎金額度依下列標準計點核給之獎金：</span> </p><p><span style="font-family: 新細明體,serif;">一、符合第四條第一款之條件者：六十點至一百點。</span> </p><p><span style="font-family: 新細明體,serif;">二、符合第四條第二款或第三款之條件者：五十點至八十點。</span> </p><p><span style="font-family: 新細明體,serif;">三、符合第四條第四款至第八款條件之一者：三十點至七十點。</span> </p><p><span style="font-family: 新細明體,serif;">四、符合第四條第九款之條件者：二十點至五十點。</span> </p><p><span style="font-family: 新細明體,serif;">每點獎金之數額，按年由行政院衛生署及經濟部工業局訂定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp; 8&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本辦法所需之獎勵經費，由下列財源籌措：</span> </p><p><span style="font-family: 新細明體,serif;">一、行政院衛生署及經濟部工業局逐年編列預算支應。</span> </p><p><span style="font-family: 新細明體,serif;">二、產業界捐贈之回饋金。</span> </p><p><span style="font-family: 新細明體,serif;">三、私人或團體指定用於本辦法獎勵之捐助。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp; 9&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">遇二個以上獎勵對象，為相同之發明或研究，分別申請獎勵時，應就最先申請者獎勵之。二個以上獎勵對象共同申請獎勵時，其所受獎勵為該共同申請人所共有。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 10&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">獎勵對象符合第四條之獎勵條件者，得由相關公、協、學會等團體推薦或直接向行政院衛生署提出申請。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 11&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本辦法自發布日施行。</span> </p> 2013-12-05 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6072&type=0
1420552 臨床試驗類,藥物基因體學研究之受檢者同意書內容參考指引 行政解釋 藥物基因體學研究者之受檢者同意書內容參考指引 詳如附件 2013-12-05 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=67&type=0;;https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=68&type=0;;https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4555&type=0
1420553 查驗登記類,藥物資料公開辦法 法規命令 藥物資料公開辦法 <p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp; 1&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本辦法依藥事法第四十條之一第二項規定訂定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp; 2&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">中央衛生主管機關必要時得公開其所為之藥物核准審查報告摘要，及持有、保管藥商申請藥物查驗登記所檢附之下列資料。但藥商申請新藥查驗登記所檢附之營業秘密資料，應保密之：</span> </p><p><span style="font-family: 新細明體,serif;">一、藥物成分及仿單。</span> </p><p><span style="font-family: 新細明體,serif;">二、臨床試驗計畫摘要。</span> </p><p><span style="font-family: 新細明體,serif;">三、藥品風險管理計畫及藥物安全相關資訊。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp; 3&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">中央衛生主管機關公開藥物查驗登記資料，其方式如下：</span> </p><p><span style="font-family: 新細明體,serif;">一、刊載於政府公報或其他出版品。</span> </p><p><span style="font-family: 新細明體,serif;">二、利用電信網路傳送或其他方式供公眾線上查詢。</span> </p><p><span style="font-family: 新細明體,serif;">三、其他足以使公眾得知之方式。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp; 4&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本辦法自發布日施行。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: calibri;">&nbsp;</span></p> 2013-12-05 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=69&type=0;;https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=70&type=0;;https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6073&type=0
1420554 化學製造管制類,藥物製造/委託製造,藥物製造工廠設廠標準 法規命令 藥物製造工廠設廠標準 <p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">一</span> <span style="font-family: 新細明體,serif;">編</span> <span style="font-family: 新細明體,serif;">總則</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 1&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本標準依藥事法（以下簡稱本法）第五十七條第五項規定訂定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 2&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">藥物製造工廠或場所之設備及衛生條件，應符合本標準之規定；本標準未規定者，依其他有關法令之規定。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 3&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">新設、遷移、擴建、復業或增加原料藥、劑型、加工項目、品項之國產藥物製造工廠，如符合第二編及工廠管理輔導法規定者，由直轄市或縣（市）工業主管機關依申請核發工廠登記證明文件或核准變更登記，並由直轄市或縣（市）衛生主管機關依申請核發製造業藥商許可執照或核准變更登記。</span> </p><p><span style="font-family: 新細明體,serif;">依前項規定取得工廠登記證明文件及製造業藥商許可執照或經核准變更登記之國產藥物製造工廠，如經檢查符合藥物優良製造準則之規定者，由中央衛生主管機關就檢查合格之項目，核發符合藥品優良製造規範或醫療器材優良製造規範之藥物製造許可。</span> </p><p><span style="font-family: 新細明體,serif;">國外藥物製造工廠如經檢查符合藥物優良製造準則之規定者，中央衛生主管機關就檢查合格之項目，核發符合藥品優良製造規範或醫療器材優良製造規範之證明文件。</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">二</span> <span style="font-family: 新細明體,serif;">編</span> <span style="font-family: 新細明體,serif;">設廠基本條件</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 4&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">藥物製造工廠，應具備下列基本條件及共同設備：</span> </p><p><span style="font-family: 新細明體,serif;">一、工廠廠址應選擇環境清潔、空氣新鮮之地帶；其製造、加工及分裝作業場所，應依建築相關法規，並與工廠周圍邊界保持足以避免污染及防火需要之適當距離。生物藥品或生物技術產品之製造工廠及設施，對病原體之安全防護，不得妨礙公共衛生及安全；廠內之排水溝並應加蓋，防止動物出入散布病原體。</span> </p><p><span style="font-family: 新細明體,serif;">二、廠房之建築應堅固安全，建築物之設計，應能防鼠、防蟲、防塵；室內天花板、牆壁及地面應保持平滑而無裂痕及縫隙，且應易於清潔而不發生粉塵，必要時應採用易於消毒清洗之材料；所有作業場所，均應有良好之照明與通風設備，必要時並應具有適當之溫度、濕度及潔淨度調節設備。</span> </p><p><span style="font-family: 新細明體,serif;">三、廠內作業場所應明確區分（如粉劑製造室、液劑製造室等），兼製環境衛生用藥者，其作業場所，應與其他藥物製造工廠保持相當之距離，必要時並應有隔離之牆壁。</span> </p><p><span style="font-family: 新細明體,serif;">四、設置原料、物料、半製品及最終產品等倉庫。</span> </p><p><span style="font-family: 新細明體,serif;">五、粉塵、廢水、有害廢棄物、有毒容器、有害氣體、生物性成分及其他有害成分或物質之處理設備。</span> </p><p><span style="font-family: 新細明體,serif;">六、工廠應設置符合規定之秤量設備，並定期校正。</span> </p><p><span style="font-family: 新細明體,serif;">七、設置容器洗滌設施。如係製造眼用液劑、注射劑及生物藥品或生物技術產品者，所用容器之洗滌設施，應特別注意防止污染，並獨立設置。</span> </p><p><span style="font-family: 新細明體,serif;">八、設置工作人員洗手設備及工作衣、帽、口罩、手套、鞋履等之洗滌或消毒滅菌設備。作業場所外，應視需要設置員工使用之休息室、浴室；製造、加工區域應具備適當之盥洗設施，並與作業場所隔離。</span> </p><p><span style="font-family: 新細明體,serif;">九、設置檢驗部門（化驗室及儀器室）及適當檢驗設備。但如符合藥物委託製造及檢驗作業準則規定，委託經主管機關認可之單位檢驗，並出具確切證明者，得免設置。</span> </p><p><span style="font-family: 新細明體,serif;">十、對於易燃性或危險性原物料、溶劑、半製品或中間產品及產品之作業場所，應有適當之防護、急救及隔離設施。</span> </p><p><span style="font-family: 新細明體,serif;">藥物製造工廠應視工作上之需要，設置鍋爐、抽水機、真空泵、壓縮機、一般用水處理、純淨水處理（如離子交換樹脂裝置等）及蒸餾水製造、吸塵排氣或空氣處理系統。</span> </p><p><span style="font-family: 新細明體,serif;">第一項第六款至第十款所列各種設備，醫療器材製造工廠得視實際需要設置。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 5&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">製造內服與毒劇外用藥品之設備，應嚴格區分，不得互為挪用。</span> </p><p><span style="font-family: 新細明體,serif;">製造人用藥品與動物用藥品之場所設備均應分開，不得在未隔絕之同一建築物作業。但使用符合人用藥品規格製造動物用藥品者，不在此限。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 6&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">散（粉）劑藥品製造工廠，應視需要設置下列設備：</span> </p><p><span style="font-family: 新細明體,serif;">一、粉碎設備。</span> </p><p><span style="font-family: 新細明體,serif;">二、篩粉設備。</span> </p><p><span style="font-family: 新細明體,serif;">三、混合設備。</span> </p><p><span style="font-family: 新細明體,serif;">四、乾燥設備。</span> </p><p><span style="font-family: 新細明體,serif;">五、粉塵收集設備。</span> </p><p><span style="font-family: 新細明體,serif;">六、其他相關設備。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 7&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">膠囊劑、軟膠囊劑藥品製造工廠，應視需要設置下列設備：</span> </p><p><span style="font-family: 新細明體,serif;">一、粉碎設備。</span> </p><p><span style="font-family: 新細明體,serif;">二、篩粉設備。</span> </p><p><span style="font-family: 新細明體,serif;">三、混合設備。</span> </p><p><span style="font-family: 新細明體,serif;">四、乾燥設備。</span> </p><p><span style="font-family: 新細明體,serif;">五、溶膠調合設備。</span> </p><p><span style="font-family: 新細明體,serif;">六、軟膠膜加工設備。</span> </p><p><span style="font-family: 新細明體,serif;">七、軟膠囊充填壓製設備。</span> </p><p><span style="font-family: 新細明體,serif;">八、自動膠囊充填或半自動膠囊充填設備。</span> </p><p><span style="font-family: 新細明體,serif;">九、粉塵收集設備。</span> </p><p><span style="font-family: 新細明體,serif;">前項第五款至第七款，係製造軟膠囊工廠常用之設備；第五款及第六款所定設備之裝置場所，應與其他場所隔開；第六款及第七款所定設備之場所，應具備空氣溫度及濕度之調節。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 8&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">顆粒劑、錠劑（含眼用錠劑）、著衣錠劑、丸劑藥品製造工廠，應視需要設置下列設備：</span> </p><p><span style="font-family: 新細明體,serif;">一、粉碎設備。</span> </p><p><span style="font-family: 新細明體,serif;">二、篩粉設備。</span> </p><p><span style="font-family: 新細明體,serif;">三、混合或煉合設備。</span> </p><p><span style="font-family: 新細明體,serif;">四、乾燥設備。</span> </p><p><span style="font-family: 新細明體,serif;">五、造粒設備。</span> </p><p><span style="font-family: 新細明體,serif;">六、整粒設備。</span> </p><p><span style="font-family: 新細明體,serif;">七、壓錠設備或製丸設備。</span> </p><p><span style="font-family: 新細明體,serif;">八、溶膠或糖漿調合、噴霧或包衣、送風、乾燥、磨光設備。</span> </p><p><span style="font-family: 新細明體,serif;">九、外殼模器、加光器。</span> </p><p><span style="font-family: 新細明體,serif;">十、粉塵收集設備。</span> </p><p><span style="font-family: 新細明體,serif;">前項第八款所定設備之場所，應與其他場所隔開。</span> </p><p><span style="font-family: 新細明體,serif;">眼用錠劑製造工廠，另應視需要設置滅菌設備、空氣潔淨、無菌充填（分裝）及無菌試驗設備。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 9&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">乳劑藥品製造工廠，應視需要設置下列設備：</span> </p><p><span style="font-family: 新細明體,serif;">一、攪拌乳化設備。</span> </p><p><span style="font-family: 新細明體,serif;">二、乳劑調勻設備。</span> </p><p><span style="font-family: 新細明體,serif;">三、乳劑充填（分裝）設備。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 10&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">懸液劑、酊劑、浸膏劑、流浸膏劑、液劑（含眼用液劑、血液透析液、灌洗用液劑）藥品製造工廠，應視需要設置下列設備：</span> </p><p><span style="font-family: 新細明體,serif;">一、蒸餾水或純淨水之製造設備。</span> </p><p><span style="font-family: 新細明體,serif;">二、液劑調配容器或液劑澄清槽或瓷缸。</span> </p><p><span style="font-family: 新細明體,serif;">三、滲漉設備。</span> </p><p><span style="font-family: 新細明體,serif;">四、浸漬設備。</span> </p><p><span style="font-family: 新細明體,serif;">五、過濾設備。</span> </p><p><span style="font-family: 新細明體,serif;">六、攪拌設備。</span> </p><p><span style="font-family: 新細明體,serif;">七、定量充填（分裝）及容器封閉設備。</span> </p><p><span style="font-family: 新細明體,serif;">八、加熱濃縮（減壓）裝置。</span> </p><p><span style="font-family: 新細明體,serif;">九、滅菌設備。</span> </p><p><span style="font-family: 新細明體,serif;">眼用液劑製造工廠，另應視需要設置空氣潔淨、無菌充填（分裝）及無菌試驗設備。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 11&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">氣化噴霧劑藥品製造工廠，應視需要設置下列設備：</span> </p><p><span style="font-family: 新細明體,serif;">一、攪拌設備。</span> </p><p><span style="font-family: 新細明體,serif;">二、充填設備。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 12&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">軟膏（含眼用軟膏）、栓劑藥品製造工廠，應視需要設置下列設備：</span> </p><p><span style="font-family: 新細明體,serif;">一、粉末研磨設備。</span> </p><p><span style="font-family: 新細明體,serif;">二、篩粉設備。</span> </p><p><span style="font-family: 新細明體,serif;">三、加熱釜。</span> </p><p><span style="font-family: 新細明體,serif;">四、調勻設備。</span> </p><p><span style="font-family: 新細明體,serif;">五、充填（分裝）設備。</span> </p><p><span style="font-family: 新細明體,serif;">六、軟膏管封閉設備。</span> </p><p><span style="font-family: 新細明體,serif;">七、栓劑模型冷凝設備。</span> </p><p><span style="font-family: 新細明體,serif;">八、滅菌設備。</span> </p><p><span style="font-family: 新細明體,serif;">九、粉塵收集設備。</span> </p><p><span style="font-family: 新細明體,serif;">前項第五款及第六款所定之設備，於不裝軟膏管之工廠，得免設置。</span> </p><p><span style="font-family: 新細明體,serif;">眼用軟膏製造工廠，另應視需要設置空氣潔淨、無菌充填（分裝）及無菌試驗設備。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 13&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">棒劑藥品製造工廠，應視需要設置下列設備：</span> </p><p><span style="font-family: 新細明體,serif;">一、混合設備。</span> </p><p><span style="font-family: 新細明體,serif;">二、充填設備。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 14&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">貼劑藥品製造工廠，應視需要設置下列設備：</span> </p><p><span style="font-family: 新細明體,serif;">一、加熱設備。</span> </p><p><span style="font-family: 新細明體,serif;">二、攪拌、捏合設備。</span> </p><p><span style="font-family: 新細明體,serif;">三、塗布設備。</span> </p><p><span style="font-family: 新細明體,serif;">四、裁切設備。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 15&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">植入劑藥品製造工廠，應視需要設置下列設備：</span> </p><p><span style="font-family: 新細明體,serif;">一、壓製或模製設備。</span> </p><p><span style="font-family: 新細明體,serif;">二、滅菌設備。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 16&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">注射劑（含腹膜透析液）藥品製造工廠，應視需要設置下列設備：</span> </p><p><span style="font-family: 新細明體,serif;">一、注射用水之製造設備。</span> </p><p><span style="font-family: 新細明體,serif;">二、安瓿切斷設備。</span> </p><p><span style="font-family: 新細明體,serif;">三、容器乾燥滅菌設備及冷卻、保管設備：應防止容器之污染，並應有效滅菌。</span> </p><p><span style="font-family: 新細明體,serif;">四、注射藥劑溶液過濾設備：應具備去熱原及除菌過濾設備。但粉末狀態者，免設。</span> </p><p><span style="font-family: 新細明體,serif;">五、準確衡量之充填設備。</span> </p><p><span style="font-family: 新細明體,serif;">六、注射劑容器封閉設備。</span> </p><p><span style="font-family: 新細明體,serif;">七、滅菌設備。</span> </p><p><span style="font-family: 新細明體,serif;">八、注射劑容器封閉狀態及洩漏檢驗設備。</span> </p><p><span style="font-family: 新細明體,serif;">九、注射劑異物檢查設備。</span> </p><p><span style="font-family: 新細明體,serif;">十、消毒室：供員工手腳洗滌消毒之用。</span> </p><p><span style="font-family: 新細明體,serif;">十一、更衣室：供員工更換已滅菌之工作衣帽、口罩、手套及鞋履之用。</span> </p><p><span style="font-family: 新細明體,serif;">十二、藥液調製室。</span> </p><p><span style="font-family: 新細明體,serif;">十三、藥劑充填及容器封閉室。</span> </p><p><span style="font-family: 新細明體,serif;">十四、動物試驗之場所、設施及設備，並配置所需之動物及其飼養觀察場所。</span> </p><p><span style="font-family: 新細明體,serif;">十五、生菌數試驗、無菌試驗或其他檢驗所需之場所、設施及設備。</span> </p><p><span style="font-family: 新細明體,serif;">十六、凍晶乾燥設備。</span> </p><p><span style="font-family: 新細明體,serif;">前項第十二款及第十三款之各室，應與其他作業場所嚴格劃分，並應設置能嚴密關閉之雙重門戶、空氣潔淨、滅菌、溫度及濕度調節等設備。</span> </p><p><span style="font-family: 新細明體,serif;">熱原試驗應以非活體動物替代方式優先。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 17&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">抗生素藥品製劑工廠，應視需要設置下列設備：</span> </p><p><span style="font-family: 新細明體,serif;">一、注射用抗生素製劑：</span> </p><p><span style="font-family: 新細明體,serif;">（一）液狀抗生素製劑，應具前條所列設備；粉狀抗生素製劑，除視其實際需要設置前條所列有關設備外，並應增加設置適當控制溫度與濕度之無菌充填（分裝）設備及自動或半自動精密天秤。</span> </p><p><span style="font-family: 新細明體,serif;">（二）通於室外之門窗，應設置能嚴密關閉之雙重門窗。</span> </p><p><span style="font-family: 新細明體,serif;">（三）應具備抗生素原料及產品之力價與安全試驗設備。</span> </p><p><span style="font-family: 新細明體,serif;">（四）加工分裝場所，應設置預備室（供分裝材料及容器之乾燥滅菌與儲藏及從事其他分裝準備工作之用）及分裝室（應設置適當控制濕度之無菌設備及自動或半自動精密天秤）。</span> </p><p><span style="font-family: 新細明體,serif;">二、非注射用抗生素製劑（如膠囊劑、錠劑、液劑、軟膏等）：除</span> <span style="font-family: 新細明體,serif;">應比照各該製劑規定之各項設備外，其加工分裝場所，應視實際需要設置空氣潔淨、滅菌、溫度及濕度調節等設備，並應具備前款第二目及第三目所定之設備。</span> </p><p><span style="font-family: 新細明體,serif;">三、青黴素類藥品之製造、加工、分裝、包裝及其他作業場所，應有完全隔開之廠房，其空氣處理系統並應與其他藥品之系統各自獨立。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 18&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">生物藥品或生物技術產品製造工廠，除作業場所之室內天花板、牆壁、門窗、地面等之構造設備，應便於洗滌及消毒外，應視需要設置下列設備：</span> </p><p><span style="font-family: 新細明體,serif;">一、製造、試驗用動物及接種微生物後之動物飼養隔離設備。</span> </p><p><span style="font-family: 新細明體,serif;">二、安全試驗與生物檢定場所、設施及設備。</span> </p><p><span style="font-family: 新細明體,serif;">三、動物採血及動物來源製造痘苗之製造廠，應有足夠沖洗之水源設備。</span> </p><p><span style="font-family: 新細明體,serif;">四、作業場所應有清理污水及消毒設備。</span> </p><p><span style="font-family: 新細明體,serif;">五、微生物培養設備。</span> </p><p><span style="font-family: 新細明體,serif;">六、微生物過濾設備。</span> </p><p><span style="font-family: 新細明體,serif;">七、微生物接種及採取設備。</span> </p><p><span style="font-family: 新細明體,serif;">八、冷凍乾燥設備。</span> </p><p><span style="font-family: 新細明體,serif;">九、稀釋原液調製設備。</span> </p><p><span style="font-family: 新細明體,serif;">十、充填（分裝）及容器密封設備。</span> </p><p><span style="font-family: 新細明體,serif;">十一、微生物之貯藏設備。</span> </p><p><span style="font-family: 新細明體,serif;">十二、製造過程中之中間產品及最終產品之貯藏設備：貯藏設備之室溫，應適合各貯藏產品之溫度。</span> </p><p><span style="font-family: 新細明體,serif;">十三、調劑用溶液及培養基調製設備。</span> </p><p><span style="font-family: 新細明體,serif;">十四、使用前、後之製造與檢驗用之器具及各種溶液、培養基等之滅菌消毒設備。</span> </p><p><span style="font-family: 新細明體,serif;">十五、恒溫器、滅菌設備、冷藏及冷凍設備，並附裝自動調節器、溫度計及其他必要之紀錄儀器。</span> </p><p><span style="font-family: 新細明體,serif;">十六、動物屍體及其他污物焚化或銷毀設備。</span> </p><p><span style="font-family: 新細明體,serif;">十七、員工更衣及沐浴設備。</span> </p><p><span style="font-family: 新細明體,serif;">十八、動物解剖及臟器磨碎設備。</span> </p><p><span style="font-family: 新細明體,serif;">十九、其他相關設備。</span> </p><p><span style="font-family: 新細明體,serif;">操作芽孢、細菌及病毒場所，應與其他場所完全隔離。</span> </p><p><span style="font-family: 新細明體,serif;">第一項第七款至第十款所定設備之場所，須係無菌室設備，並應裝設所需之無菌空氣調節器。第一項第十款設備之場所應裝設之無菌空氣調節器，須係無菌減濕空氣調節器。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 19&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">中藥磨粉工廠，應視需要設置下列設備：</span> </p><p><span style="font-family: 新細明體,serif;">一、粉碎設備。</span> </p><p><span style="font-family: 新細明體,serif;">二、篩粉設備。</span> </p><p><span style="font-family: 新細明體,serif;">三、乾燥設備。</span> </p><p><span style="font-family: 新細明體,serif;">四、粉塵收集設備。</span> </p><p><span style="font-family: 新細明體,serif;">五、分裝及包裝設備。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 20&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">中藥飲片炮製工廠，應視需要設置下列設備：</span> </p><p><span style="font-family: 新細明體,serif;">一、淨選加工設備。</span> </p><p><span style="font-family: 新細明體,serif;">二、切製處理設備。</span> </p><p><span style="font-family: 新細明體,serif;">三、切製設備。</span> </p><p><span style="font-family: 新細明體,serif;">四、乾燥設備。</span> </p><p><span style="font-family: 新細明體,serif;">五、炮製設備。</span> </p><p><span style="font-family: 新細明體,serif;">六、分裝及包裝設備。</span> </p><p><span style="font-family: 新細明體,serif;">七、其他相關設備。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 21&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">中藥膏藥（硬膏、油膏）及藥膠布製造工廠，應視需要設置下列設備：</span> </p><p><span style="font-family: 新細明體,serif;">一、粉碎設備。</span> </p><p><span style="font-family: 新細明體,serif;">二、混合設備。</span> </p><p><span style="font-family: 新細明體,serif;">三、熬膏釜爐攪拌設備。</span> </p><p><span style="font-family: 新細明體,serif;">四、膏藥塗布設備。</span> </p><p><span style="font-family: 新細明體,serif;">五、裁切設備。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 22&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">中藥碎片製造工廠，應視需要設置下列設備：</span> </p><p><span style="font-family: 新細明體,serif;">一、切片（碎）設備。</span> </p><p><span style="font-family: 新細明體,serif;">二、篩粒設備。</span> </p><p><span style="font-family: 新細明體,serif;">三、混合設備。</span> </p><p><span style="font-family: 新細明體,serif;">四、乾燥設備。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 23&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">中藥液劑、露劑、酒劑、膏滋劑、膠劑製造工廠，應視需要設置下列設備：</span> </p><p><span style="font-family: 新細明體,serif;">一、切斷（碎）設備。</span> </p><p><span style="font-family: 新細明體,serif;">二、浸漬設備。</span> </p><p><span style="font-family: 新細明體,serif;">三、過濾設備。</span> </p><p><span style="font-family: 新細明體,serif;">四、煎熬或濃縮設備。</span> </p><p><span style="font-family: 新細明體,serif;">五、蒸餾設備。</span> </p><p><span style="font-family: 新細明體,serif;">六、攪拌設備。</span> </p><p><span style="font-family: 新細明體,serif;">七、液體充填（分裝）設備。</span> </p><p><span style="font-family: 新細明體,serif;">八、膠模盤及切膠刀。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp; &nbsp;24 &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">中藥濃縮製造工廠，應視需要設置下列設備：</span> </p><p><span style="font-family: 新細明體,serif;">一、切斷（碎）設備。</span> </p><p><span style="font-family: 新細明體,serif;">二、萃取設備。</span> </p><p><span style="font-family: 新細明體,serif;">三、過濾設備。</span> </p><p><span style="font-family: 新細明體,serif;">四、減壓濃縮設備。</span> </p><p><span style="font-family: 新細明體,serif;">五、恒溫或減壓乾燥設備。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp; &nbsp;25 &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">硬空膠囊製造工廠，應視需要設置下列設備：</span> </p><p><span style="font-family: 新細明體,serif;">一、溶膠設備。</span> </p><p><span style="font-family: 新細明體,serif;">二、模製設備。</span> </p><p><span style="font-family: 新細明體,serif;">三、乾燥設備。</span> </p><p><span style="font-family: 新細明體,serif;">四、裁截及套合設備。</span> </p><p><span style="font-family: 新細明體,serif;">五、消毒滅菌設備。</span> </p><p><span style="font-family: 新細明體,serif;">六、微生物檢查設備。</span> </p><p><span style="font-family: 新細明體,serif;">七、作業場所，應設置空氣潔淨、溫度、濕度等調節設備。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp; &nbsp;26 &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫用氣體製造工廠，應視需要設置下列設備：</span> </p><p><span style="font-family: 新細明體,serif;">一、儲存設備。</span> </p><p><span style="font-family: 新細明體,serif;">二、蒸發設備。</span> </p><p><span style="font-family: 新細明體,serif;">三、空氣壓縮設備。</span> </p><p><span style="font-family: 新細明體,serif;">四、純化設備。</span> </p><p><span style="font-family: 新細明體,serif;">五、灌充或充填設備。</span> </p><p><span style="font-family: 新細明體,serif;">六、分離設備。</span> </p><p><span style="font-family: 新細明體,serif;">七、合成設備。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp; &nbsp;27&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">衛生材料類製造工廠，除各作業場所應視其性質予以區分隔離外，應視需要設置下列設備：</span> </p><p><span style="font-family: 新細明體,serif;">一、彈棉機、展棉機或梳棉機：委託整棉廠加工者，得免設置。</span> </p><p><span style="font-family: 新細明體,serif;">二、加壓脫脂設備。</span> </p><p><span style="font-family: 新細明體,serif;">三、漂洗設備。</span> </p><p><span style="font-family: 新細明體,serif;">四、脫水設備。</span> </p><p><span style="font-family: 新細明體,serif;">五、乾燥設備（乾燥室）。</span> </p><p><span style="font-family: 新細明體,serif;">六、紡紗機、織布機等紡織設備：委託棉織廠加工者，得免設置。</span> </p><p><span style="font-family: 新細明體,serif;">七、紗布裁切設備。</span> </p><p><span style="font-family: 新細明體,serif;">八、繃帶裁切設備。</span> </p><p><span style="font-family: 新細明體,serif;">九、敷料經乾燥後，應有適當防止再污染之設備。</span> </p><p><span style="font-family: 新細明體,serif;">十、絆創膏基劑或藥材料煉合設備。</span> </p><p><span style="font-family: 新細明體,serif;">十一、浸漬調合設備：係採用溶劑法者，應具有之設備。</span> </p><p><span style="font-family: 新細明體,serif;">十二、塗布設備。</span> </p><p><span style="font-family: 新細明體,serif;">十三、乾燥及滅菌設備。</span> </p><p><span style="font-family: 新細明體,serif;">十四、底布加工設備。</span> </p><p><span style="font-family: 新細明體,serif;">十五、裁切及捲布設備。</span> </p><p><span style="font-family: 新細明體,serif;">十六、藥用紗布浸漬乾燥設備。</span> </p><p><span style="font-family: 新細明體,serif;">十七、視需要設置半製品或最終產品之無菌檢查設備。</span> </p><p><span style="font-family: 新細明體,serif;">前項第一款至第五款，係製造藥用脫脂棉者常用之設備；第二款至第八款，係製造藥用紗布繃帶者常用之設備；第十款至第十五款，係製造絆創膏者常用之設備；第十五款及第十六款，係製造急救用絆創膏、藥用紗布者常用之設備。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp; &nbsp;28 &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">注射筒類製造工廠，應視需要設置下列設備：</span> </p><p><span style="font-family: 新細明體,serif;">一、瓦斯加工設備。</span> </p><p><span style="font-family: 新細明體,serif;">二、研磨加工設備。</span> </p><p><span style="font-family: 新細明體,serif;">三、刻度加工設備。</span> </p><p><span style="font-family: 新細明體,serif;">四、檢查筒管接頭設備。</span> </p><p><span style="font-family: 新細明體,serif;">五、玻璃鹼性度試驗設備。</span> </p><p><span style="font-family: 新細明體,serif;">六、裂紋檢查器。</span> </p><p><span style="font-family: 新細明體,serif;">七、熱衝擊試驗設備。</span> </p><p><span style="font-family: 新細明體,serif;">八、標準容量測定器。</span> </p><p><span style="font-family: 新細明體,serif;">九、氣密檢查器。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp; &nbsp;29 &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療用電氣器械製造工廠，應視需要設置下列設備：</span> </p><p><span style="font-family: 新細明體,serif;">一、車床。</span> </p><p><span style="font-family: 新細明體,serif;">二、鑽床。</span> </p><p><span style="font-family: 新細明體,serif;">三、千斤鼎。</span> </p><p><span style="font-family: 新細明體,serif;">四、磨床或砂輪機。</span> </p><p><span style="font-family: 新細明體,serif;">五、四分之一馬力以上之電動設備。</span> </p><p><span style="font-family: 新細明體,serif;">六、沖床。</span> </p><p><span style="font-family: 新細明體,serif;">七、試驗用配電盤。</span> </p><p><span style="font-family: 新細明體,serif;">八、檢電器。</span> </p><p><span style="font-family: 新細明體,serif;">九、電阻測定器。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp; &nbsp;30 &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">採血及輸血用器具類（使用塑膠管）製造工廠，應視需要設置下列設備：</span> </p><p><span style="font-family: 新細明體,serif;">一、高速攪拌設備。</span> </p><p><span style="font-family: 新細明體,serif;">二、冷卻攪拌設備。</span> </p><p><span style="font-family: 新細明體,serif;">三、膠粒設備。</span> </p><p><span style="font-family: 新細明體,serif;">四、高壓蒸氣滅菌設備。</span> </p><p><span style="font-family: 新細明體,serif;">五、高週波熔接設備。</span> </p><p><span style="font-family: 新細明體,serif;">六、製造無菌水裝置。</span> </p><p><span style="font-family: 新細明體,serif;">七、無菌操作室。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp; &nbsp;31 &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">注射針製造工廠，應視需要設置下列設備：</span> </p><p><span style="font-family: 新細明體,serif;">一、直線設備。</span> </p><p><span style="font-family: 新細明體,serif;">二、研磨設備。</span> </p><p><span style="font-family: 新細明體,serif;">三、針座車製設備。</span> </p><p><span style="font-family: 新細明體,serif;">四、套緊用器具。</span> </p><p><span style="font-family: 新細明體,serif;">五、彎曲試驗器。</span> </p><p><span style="font-family: 新細明體,serif;">六、彈性試驗器。</span> </p><p><span style="font-family: 新細明體,serif;">七、引拔試驗器。</span> </p><p><span style="font-family: 新細明體,serif;">八、鉗面計。</span> </p><p><span style="font-family: 新細明體,serif;">九、測微計。</span> </p><p><span style="font-family: 新細明體,serif;">十、測微尺。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;&nbsp;32 &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">分裝、包裝及標示作業場所，應視需要設置下列設備：</span> </p><p><span style="font-family: 新細明體,serif;">一、衡量器及其他必要之分裝設備（如人工計數器或自動分裝設備等）。</span> </p><p><span style="font-family: 新細明體,serif;">二、防濕用包裝設備。</span> </p><p><span style="font-family: 新細明體,serif;">三、瓶栓或瓶用封蓋設備。</span> </p><p><span style="font-family: 新細明體,serif;">四、半自動或自動安瓿印字設備。</span> </p><p><span style="font-family: 新細明體,serif;">五、批號印製設備。</span> </p><p><span style="font-family: 新細明體,serif;">六、迴轉工作台或普通作業台。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> &nbsp;&nbsp;33 &nbsp;</span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療器材製造工廠，其設備應視產品實際需要設置之；對其用以證明產品符合規定要求之檢驗、量測及試驗設備，應予記錄、管制、校正及維護。</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">三</span> <span style="font-family: 新細明體,serif;">編</span> <span style="font-family: 新細明體,serif;">附則</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp; &nbsp;34&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本標準自發布日施行。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: calibri;">&nbsp;</span></p> 2013-12-05 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6074&type=0;;https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6075&type=0
1420555 化學製造管制類,藥物製造/委託製造,藥物製造工廠設廠標準,藥物製造業者檢查辦法,生物藥品檢驗封緘作業辦法,藥品委託製造實施要點,藥物委託製造及檢驗作業準則 法規命令 藥物製造許可及優良製造證明文件核發辦法 <table width="632" style="height: 97px; width: 632px;" border="0" cellpadding="0"> <tbody> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 0cm; padding-top: 2.25pt; padding-left: 0cm; padding-right: 12pt; width: 13%; background-color: transparent;border-color: #f0f0f0;"> <p style="margin: 0cm 0cm 3.75pt;"><b><span style="font-size: 11.5pt; font-family: 細明體;"></span></b></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="margin: 0cm 0cm 3.75pt; line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;"></span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 0cm; padding-top: 2.25pt; padding-left: 0cm; padding-right: 12pt; width: 13%; background-color: transparent;border-color: #f0f0f0;"> <p style="margin: 0cm 0cm 3.75pt;"><b><span style="font-size: 11.5pt; font-family: 細明體;">&nbsp;</span></b></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="margin: 0cm 0cm 3.75pt; line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;"></span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 0cm; padding-top: 2.25pt; padding-left: 0cm; padding-right: 12pt; background-color: transparent;border-color: #f0f0f0;"> <p style="margin: 0cm 0cm 3.75pt;"><b><span style="font-size: 11.5pt; font-family: 細明體;">&nbsp;</span></b></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; background-color: transparent;border-color: #f0f0f0;"> <p style="margin: 0cm 0cm 3.75pt; line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;"></span></p> </td> </tr> </tbody></table><table width="630" style="width: 472.5pt;" border="0" cellpadding="0"> <tbody> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="margin: 0cm 0cm 3.75pt; line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 1 條 </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">本辦法依藥事法第五十七條第六項規定訂定之。 </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 2 條 </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">國產藥物製造業者經中央衛生主管機關依藥物製造業者檢查辦法之規定， </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">檢查符合藥物優良製造準則規定者，由中央衛生主管機關核發藥物製造許 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">可。依第四條第二項規定，就許可有效期間申請展延者，亦同。 </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 3 條 </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"> <p style="text-align: center; line-height: 130%;">&nbsp;</p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">藥物製造許可應登記下列事項： </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">一、藥物製造工廠名稱。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">二、藥物製造工廠地址。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">三、許可編號。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">四、專任駐廠監製人或管理代表。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">五、許可項目或作業內容。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">六、有效期限。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">前項第一款或第四款登記事項有變更者，應自變更事實發生之日起三十日 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">內，檢附附表一所列資料，並繳納費用，向中央衛生主管機關申請變更登 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">記。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">第一項第五款之申請變更，應經中央衛生主管機關依藥物製造業者檢查辦 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">法檢查合格後，始得核准。 </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 4 條 </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">國產藥品製造業者之製造許可，有效期間為二年；其生產產品之劑型、作 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">業內容及歷次檢查紀錄良好者，得增加一年至二年。國產醫療器材製造業 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">者之製造許可，有效期間為三年。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">藥物製造業者應於藥物製造許可有效期間屆滿六個月前，向中央衛生主管 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">機關申請展延。 </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 5 條 </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">輸入藥物國外製造廠經中央衛生主管機關依藥物製造業者檢查辦法規定， </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">檢查符合藥物優良製造準則規定者，由中央衛生主管機關發給核定文件。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">依第七條第二項規定，就核定文件有效期間申請展延者，亦同。 </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 6 條 </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"> <p style="text-align: center; line-height: 130%;">&nbsp;</p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">前條之核定文件應登記下列事項： </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">一、藥物製造工廠名稱。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">二、藥物製造工廠地址。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">三、核定編號。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">四、核定項目或作業內容。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">五、有效期限。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">六、代理輸入之藥商。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">前項第一款、第二款、第四款或第六款登記事項有變更者，代理輸入之藥 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">商應自變更事實發生之日起九十日內，檢附附表一所列資料，並繳納費用 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">，向中央衛生主管機關申請變更登記。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">第一項第二款之變更，以門牌整編者為限。涉及遷移者，應依藥物製造業 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">者檢查辦法申請檢查。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">第一項第四款之申請變更，應經中央衛生主管機關依藥物製造業者檢查辦 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">法檢查合格後，始得核准。 </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 7 條 </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">輸入藥品國外製造廠符合藥物優良製造準則之核定文件，有效期間為二年 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">；其生產產品之劑型、作業內容及歷次檢查紀錄良好者，得增加一年至二 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">年。輸入醫療器材國外製造廠符合藥物優良製造準則之核定文件，有效期 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">間為三年。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">代理輸入之藥商應於核定文件有效期間屆滿六個月前，向中央衛生主管機 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">關申請展延。 </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 8 條 </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"> <p style="text-align: center; line-height: 130%;">&nbsp;</p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">藥商取得藥物製造許可者，得填具申請書及檢附附表二所列資料，並繳納 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">費用，向中央衛生主管機關申領藥物優良製造證明文件（以下簡稱證明文 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">件）。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">輸入藥物國外製造廠經中央衛生主管機關實地檢查符合藥物優良製造準則 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">規定者，代理輸入之藥商得依前項規定申請證明文件。 </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 9 條 </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">藥商取得藥物製造許可或符合藥物優良製造準則之核定文件後，經中央衛 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">生主管機關廢止原許可或核定之一部或全部者，藥商應返還原領之證明文 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">件，未返還者，由中央衛生主管機關逕予公告註銷。 </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 10 條 </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">藥物製造業者停業時，應將原領之證明文件交付當地衛生主管機關保管， </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">俟復業時發還；未交付者，中央衛生主管機關得逕予註銷該證明文件。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">藥物製造業者歇業時，應報請中央衛生主管機關廢止其藥物製造許可，並 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">返還原領之證明文件，未返還者，由中央衛生主管機關逕予公告註銷。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">藥物製造業者申請復業時，應依藥物製造業者檢查辦法規定申請檢查，經 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">檢查合格後，始得製造。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">藥物製造業者停業期滿未辦理繼續停業、歇業或復業登記，經查證無營業 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">事實者，中央衛生主管機關應廢止其藥物製造許可及註銷原領之證明文件 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">輸入藥物國外製造廠經查證無營業事實者，準用前項規定。 </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 11 條 </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">本辦法所定各項書表格式，由中央衛生主管機關定之。 </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 12 條 </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">本辦法自發布日施行。 </span></p> </td> </tr> </tbody></table><div style="border-top: windowtext 1pt solid; border-right: medium none; border-bottom: medium none; padding-bottom: 0cm; padding-top: 1pt; padding-left: 0cm; border-left: medium none; padding-right: 0cm;"><p style="padding-bottom: 0cm; text-align: center; padding-top: 0cm; padding-left: 0cm; padding-right: 0cm;border: medium none;"><span style="font-size: 8pt; font-family: 新細明體,serif; display: none;">表單的底部</span> </p></div><p><span style="font-family: calibri;">&nbsp;</span></p> 2013-12-05
1420556 其他類,衛生福利部食品藥物管理署專案諮詢輔導要點 行政解釋 衛生福利部食品藥物管理署專案諮詢輔導要點 <p style="line-height: 20pt; margin: 9pt 0cm 0pt 6pt;" class="Default"><span style="font-family: 標楷體;"><span style="color: windowtext; font-size: 20pt;">衛生福利部食品藥物管理署</span><b><span style="font-size: 20pt;">藥品專案諮詢輔導要點 </span></b></span></p><p style="text-align: right; line-height: 20pt; margin: 9pt 36pt 0pt 6pt;" class="Default"><span style="font-family: arial,sans-serif; font-size: 14pt;">100</span><span style="font-family: 標楷體; font-size: 14pt;">年</span><span style="font-family: arial,sans-serif; font-size: 14pt;">08</span><span style="font-family: 標楷體; font-size: 14pt;">月</span><span style="font-family: arial,sans-serif; font-size: 14pt;">2</span><span style="font-family: 標楷體; font-size: 14pt;">日公告 </span></p><p style="text-align: right; line-height: 20pt; margin: 9pt 36pt 0pt 6pt;" class="Default"><span style="font-family: arial,sans-serif; color: windowtext; font-size: 14pt;">102</span><span style="font-family: 標楷體; color: windowtext; font-size: 14pt;">年</span><span style="font-family: arial,sans-serif; color: windowtext; font-size: 14pt;">7</span><span style="font-family: 標楷體; color: windowtext; font-size: 14pt;">月</span><span style="font-family: arial,sans-serif; color: windowtext; font-size: 14pt;">26</span><span style="font-family: 標楷體; color: windowtext; font-size: 14pt;">日修正 </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 9pt 0cm 0pt 34pt;" class="Default"><span style="font-family: 標楷體;"><span style="font-size: 14pt;">一、</span><span style="color: windowtext; font-size: 14pt;">衛</span><span style="color: windowtext; font-size: 14pt;">生福利部食品藥物管理署</span></span><span style="font-family: arial,sans-serif; color: windowtext; font-size: 14pt;">(</span><span style="font-family: 標楷體; color: windowtext; font-size: 14pt;">以下簡稱本署</span><span style="font-family: arial,sans-serif; color: windowtext; font-size: 14pt;">)</span><span style="font-family: 標楷體; color: windowtext; font-size: 14pt;">為協助我國製藥產業 </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 9pt 0cm 0pt;" class="Default"><span style="font-family: 標楷體;"><span style="color: windowtext; font-size: 14pt;">之發展，針對國內準備上市或研發中之新</span><span style="font-size: 14pt;">藥</span></span><span style="font-family: arial,sans-serif; font-size: 14pt;">(</span><span style="font-family: 標楷體; font-size: 14pt;">含生物藥品</span><span style="font-family: arial,sans-serif; font-size: 14pt;">)</span><span style="font-family: 標楷體; font-size: 14pt;">進行專 </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 9pt 0cm 0pt 27.85pt;" class="Default"><span style="font-family: 標楷體; font-size: 14pt;">案諮詢輔導，特訂定本要點。 </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 9pt 0cm 0pt 34pt;" class="Default"><span style="font-family: 標楷體;"><span style="font-size: 14pt;">二、</span><span style="font-size: 14pt;">專案諮詢輔導目標：</span> </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 9pt 0cm 0pt;" class="Default"><span style="font-family: 標楷體; font-size: 14pt;">專案諮詢輔導目標在協助專案達到下列研發里程碑：臨床前進 </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 9pt 0cm 0pt 27.85pt;" class="Default"><span style="font-family: 標楷體; font-size: 14pt;">臨床試驗階段</span><span style="font-family: arial,sans-serif; font-size: 14pt;">(First in human)</span><span style="font-family: 標楷體; font-size: 14pt;">、進入下一期臨床試驗、進入 </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 9pt 0cm 0pt 27.85pt;" class="Default"><span style="font-family: arial,sans-serif; font-size: 14pt;">Phase III</span><span style="font-family: 標楷體; font-size: 14pt;">樞紐性試驗、申請藥品查驗登記、取得藥品許可證， </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 9pt 0cm 0pt 27.85pt;" class="Default"><span style="font-family: 標楷體; font-size: 14pt;">或技術移轉、獲得國外藥品許可證、獲國外法規單位核准執行 </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 9pt 0cm 0pt 27.85pt;" class="Default"><span style="font-family: 標楷體; font-size: 14pt;">臨床試驗、獲得生技獎章等。</span><span style="font-family: arial,sans-serif; font-size: 14pt;">&nbsp; </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 2.5pt 0cm 0pt 104pt;" class="Default"><span style="font-family: 標楷體;"><span style="font-size: 14pt;">三、</span><span style="font-size: 14pt;">申請資格：</span> </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 2.5pt 0cm 0pt;" class="Default"><span style="font-family: 標楷體;"><span style="font-size: 14pt;">本</span><span style="color: windowtext; font-size: 14pt;">署得依廠</span><span style="font-size: 14pt;">商之申請或就國內準備上市或研發中之新藥</span></span><span style="font-family: arial,sans-serif; font-size: 14pt;">(</span><span style="font-family: 標楷體; font-size: 14pt;">含生 </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 2.5pt 0cm 0pt;" class="Default"><span style="font-family: 標楷體;"><span style="font-size: 14pt;">物藥品</span><span style="font-size: 14pt;">)</span><span style="font-size: 14pt;">進行專案</span><span style="font-size: 14pt;">諮詢輔導</span><span style="font-size: 14pt;">。</span> </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 2.5pt 0cm 0pt 30.1pt;" class="Default"><span style="font-family: 標楷體; font-size: 14pt;">四、申請文件： </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 2.5pt 0cm 0pt 35pt;" class="Default"><span style="font-family: arial,sans-serif; font-size: 14pt;">&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體;"><span style="font-size: 14pt;">廠商提出前項申請，應填妥如附件之申請表，並檢附不超過</span><span style="color: windowtext; font-size: 14pt;">二</span> </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 2.5pt 0cm 0pt 34.8pt;" class="Default"><span style="font-family: 標楷體;"><span style="color: windowtext; font-size: 14pt;">十</span><span style="font-size: 14pt;">頁之資料，說明以下事項：</span> </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 9pt 0cm 0pt 40.5pt;" class="Default"><span style="font-family: 標楷體; font-size: 14pt;">（一）藥品敘述，說明其中的新科技或新臨床議題，並請提供充足之背景說明、研發現況、國內外相關文獻或資料。 </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 9pt 0cm 0pt;" class="Default"><span style="font-family: 標楷體; font-size: 14pt;">（二）概述藥品預期的臨床應用。 </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 2.5pt 0cm 0pt;" class="Default"><span style="font-family: 標楷體; font-size: 14pt;">五、評選程序： </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 2.5pt 0cm 0pt 78.95pt;" class="Default"><span style="font-family: 標楷體;"><span style="font-size: 14pt;">（一）</span><span style="color: windowtext; font-size: 14pt;">本署就產品之「創新程度」、「貢獻程度」、「早收程度」與「滿足法規程度」等四項評估指標，初步評選申請案。</span> </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 2.5pt 0cm 0pt 78.95pt;" class="Default"><span style="font-family: 標楷體;"><span style="color: windowtext; font-size: 14pt;">（二）經本署初</span><span style="font-size: 14pt;">步評選符合評估指標者，且廠商同意列為財團法人醫藥品查驗中心（以下簡稱醫藥品查驗中心）之「藥物法規科學諮詢輔導指標案件</span></span><span style="font-family: arial,sans-serif; font-size: 14pt;">(Index</span><span style="font-family: 標楷體; font-size: 14pt;">，以下簡稱</span><span style="font-family: arial,sans-serif; font-size: 14pt;">IDX)</span><span style="font-family: 標楷體;"><span style="font-size: 14pt;">」</span><span style="font-size: 14pt;">，正式成<a name="OLE_LINK1">為專案諮詢輔導案件</a>。</span> </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 2.5pt 0cm 0pt;" class="Default"><span style="font-family: 標楷體;"><span style="font-size: 14pt;">六、</span><span style="font-size: 14pt;">輔導</span><span style="font-size: 14pt;">方式：</span> </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 9pt 0cm 0pt 72pt;" class="Default"><span style="font-family: 標楷體;"><span style="font-size: 14pt;">（一）本</span><span style="color: windowtext; font-size: 14pt;">署得組成專案諮詢輔導團隊，成員包含本署指定人員、醫藥品查驗中心審查人員，必要時邀請本署藥品諮議小組委員及專家學者加入。</span> </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 9pt 0cm 0pt 72pt;" class="Default"><span style="font-family: 標楷體; color: windowtext; font-size: 14pt;">（二）專案輔導團隊將每季與專案廠商聯繋，詢問目前之研發進度、預定工作項目、待解決事項、預估問題解決時間、是否有議題需徵詢法規單位，必要時召開廠商會議。 </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 9pt 0cm 0pt 72pt;" class="Default"><span style="font-family: 標楷體; color: windowtext; font-size: 14pt;">（三）專案輔導中所召開之廠商會議決議，原則上將可作為日後案件審查之參考。 </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 9pt 0cm 0pt 33.85pt;" class="Default"><span style="font-family: 標楷體;"><span style="color: windowtext; font-size: 14pt;">七、本署每年得重新檢討評估專案諮詢輔導案件，如產品未達預估成效、或因廠商研發暫停或終止，得停止專案諮詢輔導</span><span style="font-size: 14pt;">。</span></span><span style="font-family: arial,sans-serif; font-size: 14pt;">&nbsp; </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 2.5pt 0cm 0pt;" class="Default"><span style="font-family: arial,sans-serif; font-size: 14pt;">&nbsp;</span><span style="font-family: 標楷體; font-size: 14pt;">八、案件管理：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 2.5pt 0cm 0pt 51.5pt;" class="Default"><span style="font-family: arial,sans-serif; font-size: 14pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 標楷體; font-size: 14pt;">專案諮詢輔導案件依產品研發進度，分為下列二類： </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 2.5pt 0cm 0pt 51.5pt;" class="Default"><span style="font-family: arial,sans-serif; font-size: 14pt;">&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 標楷體; font-size: 14pt;">一</span><span style="font-family: arial,sans-serif; font-size: 14pt;">) </span><span style="font-family: 標楷體; font-size: 14pt;">一般輔導案件： </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 2.5pt 0cm 0pt 51.5pt;" class="Default"><span style="font-family: arial,sans-serif; font-size: 14pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 1. </span><span style="font-family: 標楷體; font-size: 14pt;">產品尚在</span><span style="font-family: arial,sans-serif; font-size: 14pt;">R&amp;D</span><span style="font-family: 標楷體; font-size: 14pt;">階段、準備或執行</span><span style="font-family: arial,sans-serif; font-size: 14pt;">Phase I </span><span style="font-family: 標楷體; font-size: 14pt;">或</span><span style="font-family: arial,sans-serif; font-size: 14pt;"> II</span><span style="font-family: 標楷體; font-size: 14pt;">臨床試驗階段。 </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 2.5pt 0cm 0pt 83pt;" class="Default"><span style="font-family: arial,sans-serif; color: windowtext; font-size: 14pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 2. </span><span style="font-family: 標楷體; color: windowtext; font-size: 14pt;">由廠商依需求主動向本署請求召開</span><span style="font-family: arial,sans-serif; color: windowtext; font-size: 14pt;">Investigational New Drug (</span><span style="font-family: 標楷體; color: windowtext; font-size: 14pt;">以下簡稱</span><span style="font-family: arial,sans-serif; color: windowtext; font-size: 14pt;">IND) Pre-filing meeting</span><span style="font-family: 標楷體; color: windowtext; font-size: 14pt;">或</span><span style="font-family: arial,sans-serif; color: windowtext; font-size: 14pt;">IND</span><span style="font-family: 標楷體; color: windowtext; font-size: 14pt;">廠商會議。 </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 2.5pt 0cm 0pt 51.5pt;" class="Default"><span style="font-family: arial,sans-serif; color: windowtext; font-size: 14pt;">&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 標楷體; color: windowtext; font-size: 14pt;">二</span><span style="font-family: arial,sans-serif; color: windowtext; font-size: 14pt;">) </span><span style="font-family: 標楷體; color: windowtext; font-size: 14pt;">積極輔導案件： </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 2.5pt 0cm 0pt 51.5pt;" class="Default"><span style="font-family: arial,sans-serif; color: windowtext; font-size: 14pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 1. </span><span style="font-family: 標楷體; color: windowtext; font-size: 14pt;">產品進入</span><span style="font-family: arial,sans-serif; color: windowtext; font-size: 14pt;">End of Phase II</span><span style="font-family: 標楷體; color: windowtext; font-size: 14pt;">臨床試驗階段。 </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 2.5pt 0cm 0pt 83pt;" class="Default"><span style="font-family: arial,sans-serif; color: windowtext; font-size: 14pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 2. </span><span style="font-family: 標楷體; color: windowtext; font-size: 14pt;">本署將主動召開</span><span style="font-family: arial,sans-serif; color: windowtext; font-size: 14pt;">IND Pre-filing meeting</span><span style="font-family: 標楷體; color: windowtext; font-size: 14pt;">或</span><span style="font-family: arial,sans-serif; color: windowtext; font-size: 14pt;">New Drug Application (</span><span style="font-family: 標楷體; color: windowtext; font-size: 14pt;">以下簡稱</span><span style="font-family: arial,sans-serif; color: windowtext; font-size: 14pt;">NDA) Pre-filing meeting</span><span style="font-family: 標楷體; color: windowtext; font-size: 14pt;">，以協助廠商於申請</span><span style="font-family: arial,sans-serif; color: windowtext; font-size: 14pt;">IND</span><span style="font-family: 標楷體; color: windowtext; font-size: 14pt;">或</span><span style="font-family: arial,sans-serif; color: windowtext; font-size: 14pt;">NDA</span><span style="font-family: 標楷體; color: windowtext; font-size: 14pt;">前了解相關缺失。 </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 2.5pt 0cm 0pt 83pt;" class="Default"><span style="font-family: arial,sans-serif; color: windowtext; font-size: 14pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 3. </span><span style="font-family: 標楷體; color: windowtext; font-size: 14pt;">廠商申請</span><span style="font-family: arial,sans-serif; color: windowtext; font-size: 14pt;">IND</span><span style="font-family: 標楷體; color: windowtext; font-size: 14pt;">或</span><span style="font-family: arial,sans-serif; color: windowtext; font-size: 14pt;">NDA</span><span style="font-family: 標楷體; color: windowtext; font-size: 14pt;">後，本署將依據實際審查狀況，主動召開廠商會議，溝通應補件與修正處。 </span></p><span style="font-family: arial,sans-serif; color: black; font-size: 14pt;"><br style="page-break-before: always;" clear="all" /></span><p style="text-align: center;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">藥品專案諮詢輔導要點</span> <span style="font-family: 標楷體; color: black; font-size: 14pt;">流程圖</span> </p><p style="text-justify: inter-ideograph; text-align: justify;">&nbsp;</p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 9pt 0cm 0pt 30pt;" class="Default"><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p style="text-justify: inter-ideograph; text-align: justify;" class="Default"><span style="font-family: 標楷體;"><span style="font-size: 9pt;">本</span><span style="color: windowtext; font-size: 9pt;">署得組成專案諮詢輔導團隊，成員包含本署指定人員、醫藥品查驗中心審查人員，必要時邀請本署藥品諮議小組委員及專家學者加入。</span> </span></p> </div> </td> </tr> </tbody></table><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p style="text-justify: inter-ideograph; text-align: justify; margin: 2.5pt 0cm 0pt -6pt;" class="Default"><span style="font-family: 標楷體;"><span style="font-size: 9pt;">本</span><span style="color: windowtext; font-size: 9pt;">署得</span><span style="font-size: 9pt;">依廠商之申請或就國內準備上市或研發中之新藥</span></span><span style="font-family: arial,sans-serif; font-size: 9pt;">(</span><span style="font-family: 標楷體;"><span style="font-size: 9pt;">含生物藥品</span><span style="font-size: 9pt;">)</span><span style="font-size: 9pt;">進行專案</span><span style="font-size: 9pt;">諮詢輔導案件</span><span style="font-size: 9pt;">評選。</span> </span></p> </div> </td> </tr> </tbody></table><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 9pt;">廠商是否同意加入查驗中心「藥物法規科學諮詢輔導指標案件</span><span style="font-family: arial,sans-serif; font-size: 9pt;">(IDX)</span><span style="font-family: 標楷體; font-size: 9pt;">」，正式成為專案諮詢輔導案件。</span> </p> </div> </td> </tr> </tbody></table><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p><span style="font-family: 標楷體; font-size: 9pt;">不列入諮詢輔導案件 </span></p> </div> </td> </tr> </tbody></table><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p><span style="font-family: 標楷體; font-size: 9pt;">不符合 </span></p> </div> </td> </tr> </tbody></table><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p><span style="font-family: 標楷體; font-size: 9pt;">符合 </span></p> </div> </td> </tr> </tbody></table><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 9pt;">就產品之「創新程度」、「貢獻程度」、「早收程度」、「滿足法規程度」等4項評估指標，初步評選申請案。 </span></p> </div> </td> </tr> </tbody></table><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p style="text-justify: inter-ideograph; text-align: justify;" class="Default"><span style="font-family: 標楷體; font-size: 9pt;">專案輔導團隊將<b>每季</b>與專案廠商聯繋，詢問目前之研發進度、預定工作項目、待解決事項、預估問題解決時間、是否有議題需徵詢法規單位，必要時召開廠商會議。專案輔導中所召開之廠商會議決議，原則上將可作為日後案件審查之參考。 </span></p> <p style="text-align: center;">&nbsp;</p> </div> </td> </tr> </tbody></table><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p><span style="font-family: 標楷體; font-size: 9pt;">是 </span></p> </div> </td> </tr> </tbody></table><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-family: 標楷體; font-size: 9pt;">否 </span></p> </div> </td> </tr> </tbody></table><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p><span style="font-family: 標楷體; font-size: 9pt;">未達成效 </span></p> </div> </td> </tr> </tbody></table><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p><span style="font-family: 標楷體; font-size: 9pt;">不列入諮詢輔導案件 </span></p> </div> </td> </tr> </tbody></table><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p><span style="font-family: 標楷體; font-size: 9pt;">本署<b>每年</b>得重新檢討評估專案諮詢輔導案件，如產品未達預估成效、或因廠商研發暫停或終止，得停止專案諮詢輔導。</span> </p> </div> </td> </tr> </tbody></table><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p><span style="font-family: 標楷體; font-size: 9pt;">停止專案諮詢輔導 </span></p> </div> </td> </tr> </tbody></table><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p><span style="font-family: 標楷體; font-size: 9pt;">依產品研發進度分類 </span></p> </div> </td> </tr> </tbody></table><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p style="text-align: center;"><b><span style="font-family: 標楷體; font-size: 9pt;">積極輔導案件</span></b><b> </b></p> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 9pt;">【產品進入</span><span style="font-size: 9pt;">End of Phase II</span><span style="font-family: 標楷體; font-size: 9pt;">臨床試驗階段。】</span> </p> </div> </td> </tr> </tbody></table><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 9pt;">本<span style="text-decoration: underline;">署</span>主動召開</span><span style="font-size: 9pt;"> IND</span><span style="font-family: 標楷體; font-size: 9pt;">或</span><span style="font-size: 9pt;">NDA Pre-filing meeting</span></p> </div> </td> </tr> </tbody></table><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 9pt;">依審查狀況，本署主動召開</span><span style="font-size: 9pt;">IND</span><span style="font-family: 標楷體; font-size: 9pt;">或</span><span style="font-size: 9pt;">NDA</span><span style="font-family: 標楷體; font-size: 9pt;">廠商會議</span> </p> </div> </td> </tr> </tbody></table><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p><span style="font-size: 9pt;">IND</span><span style="font-family: 標楷體; font-size: 9pt;">或</span><span style="font-size: 9pt;">NDA</span><span style="font-family: 標楷體; font-size: 9pt;">正式送件</span> </p> </div> </td> </tr> </tbody></table><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p style="text-align: center;"><b><span style="font-family: 標楷體; font-size: 9pt;">一般輔導案件</span></b><b> </b></p> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 9pt;">【產品尚在</span><span style="font-size: 9pt;">R&amp;D</span><span style="font-family: 標楷體; font-size: 9pt;">階段、準備或執行</span><span style="font-size: 9pt;">Phase I </span><span style="font-family: 標楷體; font-size: 9pt;">或</span><span style="font-size: 9pt;"> II</span><span style="font-family: 標楷體; font-size: 9pt;">臨床試驗階段。】</span> </p> </div> </td> </tr> </tbody></table><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 9pt;">廠商依需求，自行提出</span> </p> <p style="text-align: center;"><span style="font-size: 9pt;">IND Pre-filing meeting</span></p> </div> </td> </tr> </tbody></table><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 9pt;">廠商依需求，自行提出</span> </p> <p style="text-align: center;"><span style="font-size: 9pt;">IND</span><span style="font-family: 標楷體; font-size: 9pt;">廠商會議</span> </p> </div> </td> </tr> </tbody></table><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p><span style="font-size: 9pt;">IND</span><span style="font-family: 標楷體; font-size: 9pt;">正式送件</span> </p> </div> </td> </tr> </tbody></table></p><p style="text-align: right;">&nbsp;</p><br clear="all" /><p style="text-align: right;"><span style="padding-bottom: 0cm; padding-left: 0cm; padding-right: 0cm; font-family: 標楷體; color: black; font-size: 14pt; padding-top: 0cm;border: windowtext 1pt solid;">附件 </span></p><p style="text-align: center;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">藥品專案諮詢輔導案件申請表</span> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 46.8pt; padding-right: 5.4pt; padding-top: 0cm;border: windowtext 1pt solid;" valign="top" rowspan="3"> <p style="text-align: center; line-height: 150%;"><span style="line-height: 150%; font-family: 標楷體; color: black; font-size: 14pt;">一、</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 73.15pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; line-height: 150%;"><span style="line-height: 150%; font-family: 標楷體; color: black; font-size: 14pt;">申請單位</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 306.15pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="5"> <p style="line-height: 150%;">&nbsp;</p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 73.15pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">負責人</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 101.8pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="text-align: center;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 102.5pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">統一編號</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 101.85pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="text-align: center;">&nbsp;</p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 73.15pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">地址</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 306.15pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="5"> <p style="text-align: center;">&nbsp;</p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 46.8pt; padding-right: 5.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" rowspan="3"> <p style="text-align: center;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">二、</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 73.15pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">聯絡人</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 101.8pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="text-align: center;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 102.5pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">職稱</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 101.85pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="text-align: center;">&nbsp;</p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 73.15pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">電話</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 101.8pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="text-align: center;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 102.5pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">傳真</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 101.85pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="text-align: center;">&nbsp;</p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 73.15pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center;"><span style="color: black; font-size: 14pt;">E-mail</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 101.8pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="text-align: center;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 102.5pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 101.85pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="text-align: center;">&nbsp;</p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 46.8pt; padding-right: 5.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" rowspan="10"> <p style="text-align: center;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">三、</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 73.15pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">案件名稱</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 306.15pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="5"> <p style="text-align: center;">&nbsp;</p> </td> </tr> <tr style="height: 51.6pt;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 73.15pt; padding-right: 5.4pt; height: 51.6pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">新藥成分</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 101.8pt; padding-right: 5.4pt; height: 51.6pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="text-align: center;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 102.5pt; padding-right: 5.4pt; height: 51.6pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">稱適應症</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 101.85pt; padding-right: 5.4pt; height: 51.6pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="text-align: center;">&nbsp;</p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 73.15pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">藥品研發階段 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 306.15pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="5"> <p><span style="font-family: 新細明體,serif; color: black; font-size: 14pt;">□<span style="font: 7pt times new roman;">&nbsp;&nbsp; </span></span><span style="font-family: 標楷體; color: black; font-size: 14pt;">設計開發 □ 原型試製 □ 實驗室產品驗證 </span></p> <p><span style="font-family: 新細明體,serif; color: black; font-size: 14pt;">□<span style="font: 7pt times new roman;">&nbsp;&nbsp; </span></span><span style="color: black; font-size: 14pt;">IND </span><span style="font-family: 標楷體; color: black; font-size: 14pt;">臨床前資料準備</span><span style="font-family: 標楷體; color: black; font-size: 14pt;"> □ </span><span style="color: black; font-size: 14pt;">Phase I</span><span style="font-family: 標楷體; color: black; font-size: 14pt;">產品驗證 </span></p> <p><span style="font-family: 新細明體,serif; color: black; font-size: 14pt;">□<span style="font: 7pt times new roman;">&nbsp;&nbsp; </span></span><span style="color: black; font-size: 14pt;">Phase II</span> <span style="font-family: 標楷體; color: black; font-size: 14pt;">試量產 □ </span><span style="color: black; font-size: 14pt;">Phase III</span><span style="font-family: 標楷體; color: black; font-size: 14pt;">臨</span><span style="font-family: 標楷體; color: black; font-size: 14pt;">床試驗 </span></p> <p><span style="font-family: 新細明體,serif; color: black; font-size: 14pt;">□<span style="font: 7pt times new roman;">&nbsp;&nbsp; </span></span><span style="color: black; font-size: 14pt;">NDA</span><span style="font-family: 標楷體; color: black; font-size: 14pt;">查驗登記 (請依已完成試驗進行複選)</span></p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 73.15pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" rowspan="4"> <p style="text-align: center;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">曾有之諮詢或審查相關經驗 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 69.75pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">日期<b> </b></span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 163pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="3"> <p style="text-align: center;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">案名 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 73.4pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">案號 </span></p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 69.75pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 163pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="3"> <p style="text-align: center;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 73.4pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center;">&nbsp;</p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 69.75pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 163pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="3"> <p style="text-align: center;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 73.4pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center;">&nbsp;</p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 69.75pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 163pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="3"> <p style="text-align: center;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 73.4pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center;">&nbsp;</p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 73.15pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">重要性 </span></p> <p style="text-align: center;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 306.15pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="5"> <p><span style="font-family: 新細明體,serif; color: black; font-size: 14pt;">□<span style="font: 7pt times new roman;">&nbsp;&nbsp; </span></span><span style="font-family: 標楷體; color: black; font-size: 14pt;">具創新性&nbsp; </span><span style="color: black; font-size: 14pt;">&nbsp;&nbsp;</span><span style="font-family: 新細明體,serif; color: black; font-size: 14pt;">□ </span><span style="font-family: 標楷體; color: black; font-size: 14pt;">具貢獻性</span> </p> <p><span style="font-family: 新細明體,serif; color: black; font-size: 14pt;">□<span style="font: 7pt times new roman;">&nbsp;&nbsp; </span></span><span style="font-family: 標楷體; color: black; font-size: 14pt;">具有早</span><span style="font-family: 標楷體; color: black; font-size: 14pt;">收性</span><span style="font-family: 新細明體,serif; color: black; font-size: 14pt;">&nbsp; </span><span style="font-family: 新細明體,serif; color: black; font-size: 14pt;">□ </span><span style="font-family: 標楷體; color: black; font-size: 14pt;">符合政策鼓勵方向 </span></p> <p><span style="font-family: 標楷體; color: black; font-size: 14pt;">(</span><span style="font-family: 標楷體; color: black; font-size: 14pt;">申請者可自行評估，可重複勾選)</span> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 73.15pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">是否有政府計畫補助 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 306.15pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="5"> <p><span style="font-family: 新細明體,serif; color: black; font-size: 14pt;">□</span><span style="color: black; font-size: 14pt;">&nbsp;&nbsp; </span><span style="font-family: 標楷體; color: black; font-size: 14pt;">無</span> </p> <p><span style="font-family: 新細明體,serif; color: black; font-size: 14pt;">□</span><span style="color: black; font-size: 14pt;">&nbsp;&nbsp; </span><span style="font-family: 標楷體; color: black; font-size: 14pt;">有，補助來源或所屬計畫為_____________________</span><span style="text-decoration: underline;"> </span></p> </td> </tr> <tr style="height: 108.7pt;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 73.15pt; padding-right: 5.4pt; height: 108.7pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">廠商開發利基產品說明 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 306.15pt; padding-right: 5.4pt; height: 108.7pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="5"> </td> </tr> <tr style="height: 57.05pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 46.8pt; padding-right: 5.4pt; height: 57.05pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">四、 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 73.15pt; padding-right: 5.4pt; height: 57.05pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">對申請案件之期許或預期達成效益 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 306.15pt; padding-right: 5.4pt; height: 57.05pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="5"> </td> </tr> <tr> <td style="background-color: transparent; width: 62px;border-color: #f0f0f0;"></td> <td style="background-color: transparent; width: 98px;border-color: #f0f0f0;"></td> <td style="background-color: transparent; width: 93px;border-color: #f0f0f0;"></td> <td style="background-color: transparent; width: 43px;border-color: #f0f0f0;"></td> <td style="background-color: transparent; width: 137px;border-color: #f0f0f0;"></td> <td style="background-color: transparent; width: 38px;border-color: #f0f0f0;"></td> <td style="background-color: transparent; width: 98px;border-color: #f0f0f0;"></td> </tr> </tbody></table><p style="text-align: center;">&nbsp;</p><p style="text-justify: inter-ideograph; text-align: justify;">&nbsp;</p> 2013-12-05
1420557 化學製造管制類,藥物製造/委託製造,藥物製造業者檢查辦法 法規命令 藥物製造業者檢查辦法 <table width="566" style="margin: auto auto auto -5.6pt; width: 424.65pt;" border="0" cellpadding="0"> <tbody> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 0cm; padding-top: 2.25pt; padding-left: 0cm; padding-right: 12pt; width: 3.06%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 95.88%; background-color: transparent;border-color: #f0f0f0;"> <p style="margin: 0cm 0cm 3.75pt; line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">藥物製造業者檢查辦法 </span></p> </td> </tr> </tbody></table><table width="630" style="width: 472.5pt;" border="0" cellpadding="0"> <tbody> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="margin: 0cm 0cm 3.75pt; line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 1 條 </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">本辦法依藥事法第七十一條第三項規定訂定之。 </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 2 條 </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">應依本辦法實施檢查之藥物製造業者如下： </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">一、經營藥品製造、加工之業者。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">二、經營醫療器材製造、裝配之業者。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">三、其他與藥物製造、加工或裝配有關之業者，包括經中央衛生主管機關 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">&nbsp;&nbsp;&nbsp; </span><span style="font-size: 11.5pt; font-family: 細明體;">核准為研發而製造藥物者、兼作藥物標示及與分裝或包裝藥物有關之 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">&nbsp;&nbsp;&nbsp; </span><span style="font-size: 11.5pt; font-family: 細明體;">業者等。 </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 3 條 </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">藥物製造業者之檢查，分類如下： </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">一、藥物製造業者之新設、遷移、擴建、復業或增加原料藥、劑型、加工 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">&nbsp;&nbsp;&nbsp; </span><span style="font-size: 11.5pt; font-family: 細明體;">項目、品項之檢查。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">二、藥物製造業者後續追蹤管理之檢查。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">三、區域例行性檢查。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">四、其他檢查。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">前項第一款之國產藥物製造業者，其硬體設備及衛生條件，應符合藥物製 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">造工廠設廠標準第二編及工廠管理輔導法之規定，並由工業主管機關及直 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">轄市或縣 (市) 衛生主管機關檢查之；其軟體設備及衛生條件，應符合藥 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">物製造工廠設廠標準第三編或第四編之規定，並由中央衛生主管機關依第 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">四條或第六條規定檢查之。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">第一項第一款之國外藥物製造業者，應符合藥物製造工廠設廠標準之規定 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">，並由中央衛生主管機關依第五條或第七條規定檢查之。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">第一項第二款之檢查，國產藥物製造業者依第八條規定辦理，國外藥物製 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">造業者依第九條規定辦理。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">經中央衛生主管機關核准為研發而製造藥物者，如未申請藥物上市許可， </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">得不適用前三項規定。但其臨床試驗用藥物，應符合藥物製造工廠設廠標 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">準第三編或第四編之規定，並由衛生主管機關檢查之。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">第一項第三款之檢查，依第十一條規定辦理。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">第一項第四款之檢查，依第十二條規定辦理。 </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 4 條 </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">新設、遷移、擴建、復業或增加原料藥、劑型、加工項目之國產藥品製造 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">業者，應繳納費用，並填具藥品優良製造評鑑申請表及檢附下列資料，向 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">中央衛生主管機關申請檢查： </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">一、通過硬體檢查之證明文件或工廠登記證明文件。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">二、填具製藥工廠基本資料查核表，並依查核表所載事項檢附工廠基本資 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">&nbsp;&nbsp;&nbsp; </span><span style="font-size: 11.5pt; font-family: 細明體;">料（Site Master File，以下簡稱 SMF）。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">前項檢查，中央衛生主管機關得會同直轄市或縣（市）衛生主管機關赴廠 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">檢查之。 </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 5 條 </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">第三條第一項第一款之輸入藥品國外製造業者，應由我國代理商 (藥商) </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">繳納費用，並填具申請書表及依書表所載事項檢附該國外製造業者之工廠 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">資料 (Plant Master File ，以下簡稱 PMF) ，向中央衛生主管機關申請 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">檢查。但經中央衛生主管機關認可之國家，其製造業者之工廠資料 (PMF)</span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">，得以該業者之工廠基本資料 (SMF)&nbsp; 及該國衛生主管機關核發之稽查報 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">告替代之。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">前項工廠資料 (PMF)&nbsp; 及工廠基本資料 (SMF)&nbsp; ，應經出產國最高衛生主 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">管機關或商會簽證。但如檢附出產國最高衛生主管機關出具該製造業者符 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">合當地藥品優良製造規範之證明或載明該製造業者係符合當地藥品優良製 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">造規範之製售證明正本者，得免簽證；如出產國係德國者，其證明文件得 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">由德國邦政府衛生主管機關出具，免其聯邦政府簽證。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">第一項檢查如有實施國外查廠之必要者，申請人應向中央衛生主管機關繳 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">納費用，並與國外製造業者配合檢查要求，備齊相關資料。 </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 6 條 </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">新設、遷移、擴建、復業或增加醫療器材品項之國產醫療器材製造業者， </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">應繳納費用，並填具申請書表二份及檢附下列資料，向中央衛生主管機關 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">申請檢查： </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">一、品質手冊。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">二、工廠登記證明文件。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">三、製造業藥商許可執照。 </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 7 條 </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">第三條第一項第一款之輸入醫療器材國外製造業者，應由我國代理商（藥 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">商）繳納費用，並填具申請書表二份及檢附下列資料，向中央衛生主管機 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">關申請檢查： </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">一、該輸入醫療器材國外製造業者之品質系統文件。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">二、與醫療器材優良製造規範同等效力之符合性驗證合格登錄證書。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">三、該輸入醫療器材國外製造業者之全廠配置圖、各類產品製造作業區域 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">&nbsp;&nbsp;&nbsp; </span><span style="font-size: 11.5pt; font-family: 細明體;">、主要設備、產品製造流程；必要時，並應標示作業人員與物料搬運 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">&nbsp;&nbsp;&nbsp; </span><span style="font-size: 11.5pt; font-family: 細明體;">之通路。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">前項第一款之品質系統文件，得先檢附品質手冊與相關程序書及文件總覽 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">表。但必要時，申請人應依中央衛生主管機關之通知，補送其他品質系統 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">文件或資料。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">產地為美國之製造業者，得以美國最高衛生主管機關出具之製售證明，並 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">其內容載明該製造業者係符合美國之醫療器材優良製造規範（Current G-</span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">ood Manufacturing Practice</span><span style="font-size: 11.5pt; font-family: 細明體;">）者，替代第一項第二款資料。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">產地為美國、美屬波多黎各或關島之製造業者，於中美醫療器材技術合作 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">換文有效期間內，得以美國最高衛生主管機關出具之查廠報告書與製售證 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">明及與醫療器材優良製造規範同等效力之符合性證書（如 ISO 13485&nbsp; 證 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">書），共同替代第一項第一款至第三款之資料。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">產地為歐盟之製造業者，於中歐醫療器材技術合作換文有效期間內，或產 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">地為瑞士之製造業者，於臺瑞醫療器材技術合作換文有效期間內，得以經 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">中央衛生主管機關認可且與中央衛生主管機關醫療器材優良製造規範代施 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">查核機構簽訂查廠報告交換技術合作方案之歐盟醫療器材代施查核機構所 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">出具查廠報告書，連同該產製國最高衛生主管機關出具之製售證明及前述 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">認可代施查核機構出具與醫療器材優良製造規範同等效力之符合性證書（ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">如 ISO 13485&nbsp; 證書）共同替代第一項第一款至第三款之資料。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">第一項檢查如有實施國外檢查之必要者，申請人應向中央衛生主管機關繳 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">納費用及國外製造業者之品質手冊，並與國外製造業者配合檢查要求，備 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">齊相關資料。 </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 7-1 條 </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">申請檢查符合醫療器材優良製造規範者，所附資料如有不符規定而得補正 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">時，申請人應於通知期限內補正之。補正期限為二個月。申請人如未能於 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">期限內補正者，得於補正期滿前，申請延期一個月，且延期以一次為限。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">申請人如未於期限內補正或延期一個月後仍逾期未補正者，中央衛生主管 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">機關得依現有資料逕為檢查判定。 </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 8 條 </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">第三條第一項第二款之檢查，國產藥品製造業者每二年檢查一次，並得視 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">其生產產品之劑型、作業內容及歷次檢查紀錄，延長一年至二年。國產醫 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">療器材製造業者，每三年檢查一次。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">前項檢查，業者應於證明文件有效期間屆滿之六個月前主動提出申請。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">中央衛生主管機關於必要時或發現藥物有重大危害之情事者，得另實施不 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">定期檢查，並以不預先通知檢查對象為原則。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">第一項及前項之檢查，由中央衛生主管機關檢查藥物製造業者實施藥品優 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">良製造規範或醫療器材優良製造規範之現況，並得通知直轄市或縣（市） </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">衛生主管機關及工業主管機關派員參加。業者應配合檢查要求，並準用第 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">四條或第六條規定辦理。 </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 9 條 </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">輸入藥品國外製造業者後續追蹤管理每二年檢查一次，並得視當地國藥品 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">製造管理制度及標準延長一年至二年；其檢查除書面審查外，得視其輸入 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">產品之劑型、作業內容、歷次檢查紀錄及當地國藥品製造管理制度及標準 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">等辦理實地查核。輸入醫療器材國外製造業者每三年檢查一次。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">前項檢查，業者應於證明文件有效期間屆滿之六個月前主動提出申請。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">中央衛生主管機關於必要時或發現藥物有重大危害之情事者，得另實施不 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">定期檢查。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">第一項及前項之檢查，由中央衛生主管機關檢查藥物製造業者實施藥品優 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">良製造規範或醫療器材優良製造規範之現況；業者應配合檢查要求，並準 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">用第五條或第七條規定辦理。 </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 10 條 </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">藥物製造業者經檢查符合第四條至第九條規定之一者，由中央衛生主管機 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">關就檢查合格之項目，核發符合藥品優良製造規範或醫療器材優良製造規 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">範之證明文件。國產及輸入藥品製造業者符合優良製造規範之證明文件有 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">效期間，得配合第八條第一項及前條第一項之檢查頻率定之；醫療器材製 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">造業者符合優良製造規範之證明文件有效期間為三年。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">前項證明文件核發後，如經主管機關後續檢查發現有不符合藥品優良製造 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">規範或醫療器材優良製造規範之情形而未於期限內改善，或經發現有重大 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">危害或違規情節重大，或登記事項變更而未依規定申請變更或未獲核准變 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">更者，中央衛生主管機關得廢止該證明文件。 </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 11 條 </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">第三條第一項第三款之檢查，由直轄市或縣 (市) 衛生主管機關會同工業 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">主管機關檢查當地之藥物製造業者；其檢查期間及重點如下： </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">一、每年舉行一次。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">二、檢查重點除藥物製造業者之設備外，並包括其製造、加工、裝配之作 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">&nbsp;&nbsp;&nbsp; </span><span style="font-size: 11.5pt; font-family: 細明體;">業程序、品質管制及其成品、半成品、原料、配件容器、包裝、標籤 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">&nbsp;&nbsp;&nbsp; </span><span style="font-size: 11.5pt; font-family: 細明體;">、仿單與工廠或場所之安全、機器按裝排列及操作效率等。 </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 12 條 </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">其他檢查，由衛生主管機關及工業主管機關依相關法令規定或視需要依職 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">權辦理。 </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 13 條 </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">主管機關執行各項檢查時，得視需要邀請有關機關或專家參與。 </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 14 條 </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">檢查人員執行檢查任務時，應出示身分證明文件；檢查時，得索取並影印 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">相關文件；必要時，得取樣、照相並錄音存證。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">如受檢查業者無故拒絕、規避或妨礙時，得逕予判定該次檢查結果為不合 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">格。 </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 15 條 </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">藥物製造業者經檢查所見缺失，應依檢查機關核發之檢查報告或有關文件 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">，於期限內改善並檢送改善報告。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">執行檢查之機關得視受檢查業者之違規情節，或於受檢查業者逾期未改善 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">或其改善報告仍有缺失時，依相關法令規定處罰。 </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 15-1 條 </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">藥商申請醫療器材製造業者應符合醫療器材優良製造規範之規定；經檢查 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">不合格者，得於核定之日起二個月內提出複評，以一次為限。 </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 16 條 </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">本辦法之各項書表，由中央衛生主管機關定之。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">受檢查業者應依書表所載事項，備齊相關資料；填寫書表及檢附之資料， </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">限用繁體中文及英文；如非繁體中文或英文者，應另附繁體中文或英文譯 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">本。 </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 17 條 </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">本辦法自發布日施行。 </span></p> </td> </tr> </tbody></table> 2013-12-05 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6077&type=0
1420558 藥政管理類,藥物樣品贈品管理辦法 法規命令 藥物樣品贈品管理辦法 <p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 1&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本辦法依藥事法</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">以下簡稱本法</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">第五十五條第二項規定訂定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 2&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">藥物符合下列各款規定之一者，得申請為藥物樣品：</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: 新細明體,serif;">一、藥商申請供查驗登記或改進製造技術之用者。</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: 新細明體,serif;">二、藥商、學術研究或試驗機構、試驗委託機構、醫藥學術團體或教學醫院，因業務需要，申請專供研究、試驗之用者。</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: 新細明體,serif;">三、專科教學醫院或區域級以上教學醫院申請供診治危急或重大病患之用者。</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: 新細明體,serif;">四、病患經醫療機構出具證明申請供自用者。但應由醫師或專業人員操作之醫療器材除外。</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: 新細明體,serif;">五、醫療器材藥商申請供特定展覽或示範之醫療器材。</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: 新細明體,serif;">六、藥商申請依本法規定已核發許可證之藥物供教育宣導之用者。</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: 新細明體,serif;">七、申請供公共安全或公共衛生或重大災害之用者。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 3&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本辦法所稱藥物贈品，係指依本法規定已核發許可證之藥物，申請中央衛生主管機關核准贈與各級衛生醫療機構、醫院診所或救濟機構作為慈善事業使用者。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 4&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">藥物樣品或贈品應由申請者填具申請書，詳列品名、製造廠名、產地、規格或包裝形態及數量，敘明申請理由與用途，並檢附申請者資格證明文件影本及第七條至第十五條規定資料，向中央衛生主管機關提出申請，經核准後始可製造、輸入或提取。</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: 新細明體,serif;">前項申請者資格證明文件，指病患身分證或護照、藥商許可執照或機構、團體登記證照等。但機關或醫院以蓋印信公文提出申請者免附。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 5&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">申請供重大災害使用之藥物樣品，不適用前條之規定，中央衛生主管機關得視情況認定核准之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 6&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">藥物樣品申請數量，以實際需要量為限。但申請供改進技術、特定展覽或示範之醫療器材樣品，除特殊情形外，同一型號以一部</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">個</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">為限。</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: 新細明體,serif;">依第二條第四款規定申請者，除準用前項規定外，並應符合下列各款規定：</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">一、處方藥品不得超過處方箋之合理用量。</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: 新細明體,serif;">二、非處方藥品於六個月內不得重複申請。除特殊需要，應申請中央衛生主管機關核准外，每次數量不得超過十二瓶或軟管類十二支或總量一千二百顆。</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: 新細明體,serif;">三、醫療器材儀器同一型號以一部為限，屬耗材或衛生材料類者，不得超過六個月用量。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 7&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">依第二條第一款規定申請供改進製造技術用之藥品或醫療器材樣品，應檢附下列資料：</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: 新細明體,serif;">一、執行改進製造技術之學術研究單位證明或藥品製造業、醫療器材製造業藥商許可執照影本。</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: 新細明體,serif;">二、載明經核准之藥品或醫療器材樣品絕不轉售、轉供他用及供臨床使用之切結書。</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: 新細明體,serif;">三、改進技術相關資料。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 8&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">依第二條第二款規定申請供非臨床研究或體外試驗研究用之藥物樣品，應檢附下列資料：</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: 新細明體,serif;">一、研究試驗計畫書。</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: 新細明體,serif;">二、藥物相關資料。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 9&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">依第二條第二款規定申請原產國未核准上市之試驗用藥品，供臨床試驗之用者，應檢附下列資料：</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: 新細明體,serif;">一、執行試驗之準醫學中心以上教學醫院人體試驗委員會同意書，或執行特殊用藥試驗之專科教學醫院人體試驗委員會同意書。</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: 新細明體,serif;">二、符合醫療法施行細則第五十條規定之人體試驗計畫書。</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: 新細明體,serif;">三、受試者同意書。</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: 新細明體,serif;">前項藥品屬生物藥品者，並應檢附前次申請樣品之流向資料。但首次申請者，不在此限。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 10&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">依第二條第二款規定申請原產國已核准上市之試驗用藥品，供臨床試驗之用者，應檢附下列資料：</span><span style="font-family: calibri;">&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">一、執行試驗之區域級以上教學醫院人體試驗委員會同意書，或執行特殊用藥試驗之專科教學醫院人體試驗委員會同意書。</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: 新細明體,serif;">二、符合醫療法施行細則第五十條規定之人體試驗計畫書。</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: 新細明體,serif;">三、受試者同意書。</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: 新細明體,serif;">四、藥品原產國上市證明。</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;</span></p><p><span style="font-family: 新細明體,serif;">前項藥品屬生物藥品者，準用第九條第二項之規定。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 11&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">依第二條第二款規定申請原產國未核准上市之試驗醫療器材，供臨床試驗之用者，應檢附下列資料：</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: 新細明體,serif;">一、執行試驗之準醫學中心以上教學醫院人體試驗委員會同意書。</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: 新細明體,serif;">二、試驗醫療器材之結構、規格、性能、用途及圖樣等技術資料。</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: 新細明體,serif;">三、試驗醫療器材之安全性及功效性相關試驗資料。</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: 新細明體,serif;">四、符合醫療法施行細則第五十條規定之人體試驗計畫書。</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: 新細明體,serif;">五、受試者同意書。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 12&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">依第二條第二款規定申請原產國已核准上市之醫療器材，供臨床試驗之用者，應檢附下列資料：</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: 新細明體,serif;">一、執行試驗之區域級以上教學醫院人體試驗委員會同意書。、</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">二、醫療器材原產國上市證明。</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</span><span style="font-family: 新細明體,serif;">三、符合醫療法施行細則第五十條規定之人體試驗計畫書。</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">四、受試者同意書。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 13&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">依第二條第三款規定申請藥物樣品，應檢附下列資料：</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">一、申請醫院人體試驗委員會同意書。</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">二、完整之治療方式、療程及相關文獻。</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">三、病患同意書。</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">四、藥物原產國上市證明、仿單或各國醫藥品集收載影本。</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">申請藥物樣品之適應症、用法用量與原核定不符者，除前項各款</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">規定資料外，中央衛生主管機關得令申請者檢附相關臨床文獻。</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">第一項樣品屬生物藥品者，準用第九條第二項之規定。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 14&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">依第二條第四款規定申請藥物樣品自用者，應檢附下列資料：</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">一、收件人為病患姓名之國際包裹招領單或海關提單。</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">二、藥物外盒、說明書、仿單或目錄。</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">三、載明「經核准之藥物樣品絕不出售、轉讓與轉供治療其他病</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">患之用」之切結書。</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">申請樣品屬處方藥品或醫療器材者，並應檢附國內醫療院所出具</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">之診斷證明及醫師處方，或由中央衛生主管機關認定之國外原就</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">診之醫療院所出具之診斷證明及醫師處方。</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">除前二項規定資料外，必要時，中央衛生主管機關得令申請者檢</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">附藥物原產國上市證明。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 15&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">依第二條第五款規定申請醫療器材樣品供特定展覽或示範之用</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">者，應檢附下列資料：</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">一、醫療器材仿單、說明書或目錄及其中譯本。</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">二、醫學會、學術機構或醫療院所同意展示函。</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">三、載明經核准之醫療器材樣品，絕不出售、讓與、轉供他用與</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">用於臨床治療及依第十七條規定按時退運之切結書。</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">具輻射之醫療器材，並應檢附行政院原子能委員會同意書。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 16&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">符合第二條第五款規定並經核准之醫療器材樣品，其展覽或示範</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">期間不得超過六個月。</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">申請者應將下列醫療器材於展覽、示範期間結束或治療、臨床試</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">驗計畫完成後一個月內退運原廠，並將海關退運出口證明文件送</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">中央衛生主管機關核辦：</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">一、符合第二條第五款規定並經核准之醫療器材樣品。</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">二、符合第二條第二或第三款規定並經核准之醫療器材儀器樣</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">品。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 17&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">經核准之藥物樣品或贈品，不得出售、讓與或轉供他用；供改進</span><span style="font-family: calibri;">&nbsp;&nbsp; </span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">技術用之藥物樣品，並不得為臨床使用。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 18&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">經核准之藥物贈品及供教育宣導之藥物樣品，其仿單、標籤及包</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">裝式樣，應與原核發許可證登記事項相符。供教育宣導之藥物樣</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</span><span style="font-family: 新細明體,serif;">品包裝容量，並不得多於其原登記之最小包裝量。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 19&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">經核准之藥物樣品或贈品包裝，應於封面上標示明顯之「樣品」</span><span style="font-family: calibri;">&nbsp;&nbsp; </span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">或「贈品」字樣。其供臨床試驗用者，並應標示「臨床試驗用」</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">字樣。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 20&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本辦法自發布日施行。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: calibri;">&nbsp;</span></p> 2013-12-05
總共 247 筆，顯示第 51 到第 100 筆