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| column | value |
|---|---|
| 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」附件四學名藥查驗登記應檢附資料表 - 複製 |
| 條文內容 | <p style="layout-grid-mode: char; margin: 0cm 0cm 9pt 48pt;"><span style="font-family: 標楷體;">附件四</span> </p><p style="layout-grid-mode: char; text-align: center; margin: 0cm 0cm 9pt 48pt;"><span style="font-family: 標楷體;">學名<span style="color: #000000;">藥查驗登記應檢附資料表</span></span> </p><div style="text-align: center;"><table width="624" style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="height: 11.4pt; page-break-inside: avoid;"> <td style="border-top: windowtext 1pt solid; height: 11.4pt; border-right: black 1pt solid; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 205.9pt; background-color: transparent;" rowspan="3"> <p style="layout-grid-mode: char; text-align: justify; text-justify: distribute-all-lines; -11: ;"><span style="font-size: 10pt; font-family: 標楷體; text-transform: uppercase; layout-grid-mode: line; color: #000000;">應檢送資料 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; height: 11.4pt; border-right: windowtext 1pt solid; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 261.8pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="8"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; text-transform: uppercase; layout-grid-mode: line; color: #000000;">學 名 藥 </span></p> </td> </tr> <tr style="height: 6.15pt; page-break-inside: avoid;"> <td style="height: 6.15pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 99pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="3"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; text-transform: uppercase; layout-grid-mode: line; color: #000000;">監視藥品(含監視期間及監視期滿藥品)</span></p> </td> <td style="height: 6.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 81pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="3"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; text-transform: uppercase; layout-grid-mode: line; color: #000000;">一般學名藥 </span></p> </td> <td style="height: 6.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 81.8pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; text-transform: uppercase; layout-grid-mode: line; color: #000000;">醫用氣體</span> </p> </td> </tr> <tr style="height: 10.15pt; page-break-inside: avoid;"> <td valign="top" style="height: 10.15pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">國產 </span></p> </td> <td valign="top" style="height: 10.15pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">輸入 </span></p> </td> <td valign="top" style="height: 10.15pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">國產 </span></p> </td> <td valign="top" style="height: 10.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">輸入 </span></p> </td> <td valign="top" style="height: 10.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">國產 </span></p> </td> <td valign="top" style="height: 10.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">輸入 </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 205.9pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">規費 </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 205.9pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">藥品查驗登記申請書正、副本 </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 205.9pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">切結書（甲） </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 205.9pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">切結書（乙） </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 205.9pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">仿單標籤黏貼表二份 </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 205.9pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">證照黏貼表 </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> </tr> <tr style="height: 7.5pt; page-break-inside: avoid;"> <td valign="top" style="height: 7.5pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 205.9pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">製造管制標準書（包括批次紀錄中之下料量）或批次製造紀錄 </span></p> </td> <td valign="top" style="height: 7.5pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 7.5pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 7.5pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 7.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 7.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 7.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 205.9pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">有效成分檢驗規格與方法及成績書 </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 205.9pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">賦形劑檢驗規格與方法及成績書 </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 205.9pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">成品檢驗規格與方法及成績書 </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> </tr> <tr style="height: 8.95pt; page-break-inside: avoid;"> <td valign="top" style="height: 8.95pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 205.9pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">安定性試驗資料 </span></p> </td> <td valign="top" style="height: 8.95pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 8.95pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 8.95pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 8.95pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 8.95pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 8.95pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">△ </span></p> </td> </tr> <tr style="height: 10.9pt; page-break-inside: avoid;"> <td valign="top" style="height: 10.9pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 205.9pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">符合藥品優良製造規範之證明文件影本 </span></p> </td> <td valign="top" style="height: 10.9pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 10.9pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 10.9pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 10.9pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 10.9pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○<sup>＊1</sup> </span></p> </td> <td valign="top" style="height: 10.9pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○<sup>＊1</sup> </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 205.9pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">出產國許可製售證明 </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> </tr> <tr style="height: 10.6pt; page-break-inside: avoid;"> <td valign="top" style="height: 10.6pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 205.9pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">委託書 </span></p> </td> <td valign="top" style="height: 10.6pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> <td valign="top" style="height: 10.6pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 10.6pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> <td valign="top" style="height: 10.6pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 10.6pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> <td valign="top" style="height: 10.6pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> </tr> <tr style="height: 5.65pt; page-break-inside: avoid;"> <td valign="top" style="height: 5.65pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 205.9pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">分析方法確效資料 </span></p> </td> <td valign="top" style="height: 5.65pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 5.65pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 5.65pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○<sup>＊1</sup> </span></p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○<sup>＊1</sup> </span></p> </td> </tr> <tr style="height: 8.3pt; page-break-inside: avoid;"> <td valign="top" style="height: 8.3pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 205.9pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">關鍵性製程確效資料 </span></p> </td> <td valign="top" style="height: 8.3pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 8.3pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 8.3pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 8.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 8.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○<sup>＊1</sup> </span></p> </td> <td valign="top" style="height: 8.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○<sup>＊1</sup> </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: black 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: 205.9pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">臨床試驗、生體可用率試驗、生體相等性試驗 </span></p> </td> <td valign="top" style="border-right: black 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: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">＋ </span></p> </td> <td valign="top" style="border-right: black 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: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">＋ </span></p> </td> <td valign="top" style="border-right: black 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: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">＋＋ </span></p> </td> <td valign="top" style="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: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">＋＋ </span></p> </td> <td valign="top" style="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: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> <td valign="top" style="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: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: black 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: 205.9pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">送驗＊2</span></p> </td> <td valign="top" style="border-right: black 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: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> <td valign="top" style="border-right: black 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: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> <td valign="top" style="border-right: black 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: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> <td valign="top" style="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: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> <td valign="top" style="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: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> <td valign="top" style="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: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> </tr> <tr> <td style="width: 275px; background-color: transparent;border-color: #f0f0f0;"></td> <td style="width: 58px; background-color: transparent;border-color: #f0f0f0;"></td> <td style="width: 58px; background-color: transparent;border-color: #f0f0f0;"></td> <td style="width: 16px; background-color: transparent;border-color: #f0f0f0;"></td> <td style="width: 43px; background-color: transparent;border-color: #f0f0f0;"></td> <td style="width: 58px; background-color: transparent;border-color: #f0f0f0;"></td> <td style="width: 7px; background-color: transparent;border-color: #f0f0f0;"></td> <td style="width: 51px; background-color: transparent;border-color: #f0f0f0;"></td> <td style="width: 58px; background-color: transparent;border-color: #f0f0f0;"></td> </tr> </tbody></table></div><p style="layout-grid-mode: char; text-align: justify; margin: 9pt 0cm 0pt 20pt; text-justify: inter-ideograph; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">註：○：表示須檢附該項目之資料。 ╳：表示不須檢附該項目之資料。 </span><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">△：</span><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">表示視個案而定。 </span></p><p style="layout-grid-mode: char; text-align: justify; margin: 0cm 4pt 0pt 43.6pt; text-justify: inter-ideograph;"><span style="font-size: 10pt;">*1</span><span style="font-size: 10pt; font-family: 標楷體;">：表示應另依中央衛生主管機關相關公告規定辦理。</span> </p><p style="layout-grid-mode: char; text-align: justify; margin: 0cm 4pt 0pt 43.6pt; text-justify: inter-ideograph;"><span style="font-size: 10pt;">*2</span><span style="font-size: 10pt; font-family: 標楷體;">：</span><span style="font-size: 10pt; font-family: 標楷體;">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> </p><p style="layout-grid-mode: char; text-align: justify; margin: 0cm 4pt 0pt 40.6pt; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">＋：監視藥品之學名藥，監視期間內應檢附與以新藥提出查驗登記申請且取得許可證之廠商相同標準之國內臨床試驗報告</span><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">（含銜接性試驗）；如前述新藥於查驗登記核准時未檢送國內臨床試驗報告（含銜接性試驗）者，則其學名藥應檢送（1）生體相等</span><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">性試驗報告，或（2）生體可用率及臨床試驗報告。</span><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">監視期滿藥品，應檢送（1）生體相等性試驗報告，或（2）生體可用率及臨床試驗報告。 </span></p><p style="layout-grid-mode: char; text-align: justify; margin: 0cm 4pt 0pt 51.1pt; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體;">＋＋：一般學名藥如係控釋劑型製劑或屬中央衛生主管機關公告須執行生體相等性試驗之品目者，應檢送（1）生體相等性試驗報告，或（2）生體可用率及臨床試驗報告。 </span></p><p style="layout-grid-mode: char; text-align: justify; margin: 0cm 4pt 0pt 51.1pt; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體;">一、國產管制藥品查驗登記應另檢附管制藥品原料申請核准證明或挪用證明。 </span></p><p style="layout-grid-mode: char; text-align: justify; margin: 0cm 4pt 0pt 41.3pt; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體;">二、安定性試驗資料包括書面作業程序、試驗報告、指標之定量分析方法及其方法之驗證等各一份。 </span></p><p style="layout-grid-mode: char; text-align: justify; margin: 0cm 4pt 0pt 51.1pt; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體;">三、申請輸入藥品查驗登記，如係無菌製劑產品者，其關鍵性製程確效應含滅菌確效資料。 </span></p><p style="layout-grid-mode: char; text-align: justify; margin: 0cm 4pt 0pt 51.1pt; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體;">四、委託製造或檢驗者，應附委託製造或檢驗契約書。 </span></p><p style="layout-grid-mode: char; text-align: justify; margin: 0cm 4pt 0pt 41.3pt; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體;">五、醫用氣體係指供醫療用且含量各為百分之九十九．○v/v以上之二氧化碳（CO<sub>2</sub>）、氧氣（O<sub>2</sub>）及氧化亞氮（N<sub>2</sub>O）等三品項，其中二氧化碳（CO<sub>2</sub>）及氧氣（O<sub>2</sub>）之製造方法係源自大氣分離者，得免附安定性試驗資料，惟須留廠備查。 </span></p> |
| 發佈日期 | 2013-12-03 |
| 附件檔案 | https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6097&type=0 |