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  2. 藥品法規條文資料集
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類別 查驗登記類,藥品查驗登記審查準則,人用血漿製劑之查驗登記,生物性體外診斷試劑之查驗登記,疫苗類藥品之查驗登記,基因工程藥品之查驗登記,生物相似性藥品之查驗登記,過敏原生物藥品之查驗登記
法規性質 法規命令
法規名稱 「藥品查驗登記審查準則」附件八原料藥查驗登記應檢附資料表 - 複製
條文內容 <p style="layout-grid-mode: char; text-align: justify; margin: 0cm 0cm 12.5pt; text-justify: inter-ideograph; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">附件八</span> </p><p style="layout-grid-mode: char; text-align: center; margin: 0cm 0cm 12.5pt; line-height: 12pt;"><span style="font-family: 標楷體;">原料藥查驗登記應檢附資料表</span> </p><div style="text-align: center;"><table width="582" style="border-collapse: collapse; margin: auto auto auto -65.75pt;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="height: 33.15pt; page-break-inside: avoid;"> <td style="height: 33.15pt; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 8cm; background-color: transparent;border: windowtext 1pt solid;" rowspan="2"> <p style="text-align: justify; text-justify: inter-ideograph; text-autospace: ;"><span style="font-size: 10pt; font-family: 標楷體;">應檢附資料</span> </p> </td> <td style="border-top: windowtext 1pt solid; height: 33.15pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 70.3pt; background-color: transparent; border-left-color: #f0f0f0;" rowspan="2"> <p style="text-align: center; line-height: 14pt; text-autospace: ;"><span style="font-size: 10pt; font-family: 標楷體;">一般原料藥</span> </p> </td> <td style="border-top: windowtext 1pt solid; height: 33.15pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 139.7pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="text-align: center; line-height: 14pt;"><span style="font-size: 10pt; font-family: 標楷體;">外銷專用原料藥</span> </p> </td> </tr> <tr style="height: 33.2pt; page-break-inside: avoid;"> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 73.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; text-autospace: ;"><span style="font-size: 10pt; font-family: 標楷體;">非臨櫃 </span></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 66.1pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 10pt; font-family: 標楷體;">臨櫃<sup>*3</sup> </span></p> </td> </tr> <tr style="height: 33.15pt;"> <td style="height: 33.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 8cm; background-color: transparent;"> <p style="text-align: justify; text-justify: inter-ideograph; line-height: 12pt; text-autospace: ;"><span style="font-size: 10pt; font-family: 標楷體;">規費</span> </p> </td> <td style="height: 33.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 70.3pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td style="height: 33.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 73.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td style="height: 33.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 66.1pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> </tr> <tr style="height: 33.2pt;"> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 8cm; background-color: transparent;"> <p style="text-align: justify; text-justify: inter-ideograph; line-height: 12pt; text-autospace: ;"><span style="font-size: 10pt; font-family: 標楷體;">藥品查驗登記申請書正本、副本</span> </p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 70.3pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 73.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 66.1pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> </tr> <tr style="height: 33.2pt;"> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 8cm; background-color: transparent;"> <p style="text-align: justify; text-justify: inter-ideograph; line-height: 12pt; text-autospace: ;"><span style="font-size: 10pt; font-family: 標楷體;">切結書（甲）、切結書（乙）</span> </p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 70.3pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 73.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 66.1pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> </tr> <tr style="height: 33.15pt;"> <td style="height: 33.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 8cm; background-color: transparent;"> <p style="line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">外銷專用切結書</span> </p> </td> <td style="height: 33.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 70.3pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">╳ </span></p> </td> <td style="height: 33.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 73.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td style="height: 33.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 66.1pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> </tr> <tr style="height: 33.2pt;"> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 8cm; background-color: transparent;"> <p style="line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">外銷專用原料藥臨櫃查驗登記申請切結書</span> </p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 70.3pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">╳ </span></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 73.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">╳ </span></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 66.1pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> </tr> <tr style="height: 33.2pt;"> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 8cm; background-color: transparent;"> <p style="text-align: justify; text-justify: inter-ideograph; line-height: 12pt; text-autospace: ;"><span style="font-size: 10pt; font-family: 標楷體;">仿單標籤黏貼表二份</span> </p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 70.3pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 73.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 66.1pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> </tr> <tr style="height: 33.15pt;"> <td style="height: 33.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 8cm; background-color: transparent;"> <p style="text-align: justify; text-justify: inter-ideograph; line-height: 12pt; text-autospace: ;"><span style="font-size: 10pt; font-family: 標楷體;">證照黏貼表</span> </p> </td> <td style="height: 33.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 70.3pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td style="height: 33.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 73.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td style="height: 33.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 66.1pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">△<sup>*4</sup> </span></p> </td> </tr> <tr style="height: 33.2pt;"> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 8cm; background-color: transparent;"> <p style="text-align: justify; text-justify: inter-ideograph; line-height: 12pt; text-autospace: ;"><span style="font-size: 10pt; font-family: 標楷體;">近二年內查核符合原料藥</span><span style="font-size: 10pt;">GMP</span><span style="font-size: 10pt; font-family: 標楷體;">之證明影本</span> </p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 70.3pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">△ </span></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 73.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">╳ </span></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 66.1pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> </tr> <tr style="height: 33.2pt;"> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 8cm; background-color: transparent;"> <p style="text-align: justify; text-justify: inter-ideograph; line-height: 12pt; text-autospace: ;"><span style="font-size: 10pt; font-family: 標楷體;">委託書（輸入藥品）</span> </p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 70.3pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 73.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">╳ </span></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 66.1pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">╳ </span></p> </td> </tr> <tr style="height: 33.15pt;"> <td style="height: 33.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 8cm; background-color: transparent;"> <p style="text-align: justify; text-justify: inter-ideograph; line-height: 12pt; text-autospace: ;"><span style="font-size: 10pt; font-family: 標楷體;">出產國許可製售證明（輸入藥品）</span> </p> </td> <td style="height: 33.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 70.3pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td style="height: 33.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 73.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">╳ </span></p> </td> <td style="height: 33.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 66.1pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">╳ </span></p> </td> </tr> <tr style="height: 33.2pt;"> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 8cm; background-color: transparent;"> <p style="text-align: justify; text-justify: inter-ideograph; line-height: 12pt; text-autospace: ;"><span style="font-size: 10pt; font-family: 標楷體;">技術性資料</span><sup><span style="font-size: 10pt;">*1</span></sup><sup> </sup></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 70.3pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">○<sup>*2</sup> </span></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 73.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">○<sup>*2</sup> </span></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 66.1pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">○<sup>*2</sup> </span></p> </td> </tr> <tr style="height: 33.2pt;"> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 8cm; background-color: transparent;"> <p style="text-align: justify; text-justify: inter-ideograph; line-height: 12pt; text-autospace: ;"><span style="font-size: 10pt; font-family: 標楷體;">送驗</span><sup><span style="font-size: 10pt;">*5</span></sup> </p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 70.3pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 10pt; font-family: 標楷體;">╳ </span></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 73.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 10pt; font-family: 標楷體;">╳ </span></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 66.1pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 10pt; font-family: 標楷體;">╳ </span></p> </td> </tr> </tbody></table></div><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; line-height: 18pt;">&nbsp;</p><p style="layout-grid-mode: char; margin: 0cm 7.55pt 0pt 31.5pt;"><span style="font-size: 11pt; font-family: 標楷體; color: #000000;">○ 表示須檢附該項目之資料。 </span></p><p style="layout-grid-mode: char; margin: 0cm 7.55pt 0pt 31.5pt;"><span style="font-size: 11pt; font-family: 標楷體; color: #000000;">△ 表示視個案而定。 </span></p><p style="layout-grid-mode: char; margin: 0cm 7.55pt 0pt 31.5pt;"><span style="font-size: 11pt; font-family: 標楷體; color: #000000;">╳：表示不須檢附該項目之資料。 </span></p><p style="layout-grid-mode: char; margin: 0cm 7.55pt 0pt 46.2pt;"><span style="font-size: 11pt; font-family: 標楷體; color: #000000;">*1 </span><span style="font-size: 11pt; font-family: 標楷體; color: #000000;">參見「原料藥查驗登記應檢附之技術性資料表」。 </span></p><p style="layout-grid-mode: char; margin: 0cm 7.55pt 0pt 46.2pt;"><span style="font-size: 11pt; font-family: 標楷體; color: #000000;">*2 </span><span style="font-size: 11pt; font-family: 標楷體; color: #000000;">應檢附技術性資料之份數，原則上，一般原料藥為十四份、外銷專用者為二份。 </span></p><p style="layout-grid-mode: char; margin: 0cm 7.55pt 0pt 46.2pt;"><span style="font-size: 11pt; font-family: 標楷體; color: #000000;">*3 </span><span style="font-size: 11pt; font-family: 標楷體; color: #000000;">限申請日前二年內，經查核符合原料藥廠GMP者。 </span></p><p style="layout-grid-mode: char; margin: 0cm 7.55pt 0pt 46.2pt;"><span style="font-size: 11pt; font-family: 標楷體; color: #000000;">*4 </span><span style="font-size: 11pt; font-family: 標楷體; color: #000000;">如已領有原料藥許可證，且許可證尚在有效期限內者，得免附。 </span></p><span style="font-size: 11pt; font-family: 標楷體; color: #000000;">*5 </span><span style="font-size: 11pt; font-family: 標楷體; color: #000000;">依第二十四條第二項規定，除經中央衛生主管機關認有必要送驗者外，得以書面審核而免送驗樣品</span>
發佈日期 2013-12-03
附件檔案 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6093&type=0