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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」附件六生物藥品查驗登記應檢附資料表 |
| 條文內容 | <p style="layout-grid-mode: char; 48pt: ;"><span style="font-family: 標楷體; color: #000000;">附件六</span> </p><p style="layout-grid-mode: char; text-align: center; 48pt: ;"><span style="font-family: 標楷體; color: #000000;">生物藥品查驗登記應檢附資料表</span> </p><table width="722" style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="height: 10.85pt; page-break-inside: avoid;"> <td valign="top" style="height: 10.85pt; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 217.4pt; background-color: transparent;border: windowtext 1pt solid;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">應檢送資料 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; height: 10.85pt; 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: 99pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">基因工程藥品（含生物相似性藥品）</span><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">＊3</span> </p> </td> <td style="border-top: windowtext 1pt solid; height: 10.85pt; 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: 56.25pt; 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; color: #000000;">疫苗類藥品 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; height: 10.85pt; 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: 56.25pt; 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; color: #000000;">人用血漿藥品 </span></p> </td> <td style="border-top: windowtext 1pt solid; height: 10.85pt; 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: 56.25pt; 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; color: #000000;">過敏原藥品 </span></p> </td> <td style="border-top: windowtext 1pt solid; height: 10.85pt; 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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 0cm -41.75pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">其他類 </span></p> </td> </tr> <tr style="height: 6.5pt; page-break-inside: avoid;"> <td valign="top" style="height: 6.5pt; 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: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">規費 </span></p> </td> <td valign="top" style="height: 6.5pt; 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: 99pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 6.5pt; 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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 6.5pt; 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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 6.5pt; 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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 6.5pt; 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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <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; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">藥品查驗登記申請書正、副本 </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: 99pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> </tr> <tr style="height: 6.9pt; page-break-inside: avoid;"> <td valign="top" style="height: 6.9pt; 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: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">切結書（甲） </span></p> </td> <td valign="top" style="height: 6.9pt; 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: 99pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 6.9pt; 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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 6.9pt; 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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 6.9pt; 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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 6.9pt; 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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> </tr> <tr style="height: 10.9pt; page-break-inside: avoid;"> <td valign="top" style="height: 10.9pt; 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: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; 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padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 10.9pt; 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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 10.9pt; 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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <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; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">仿單標籤黏貼表二份 </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: 99pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <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; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">證照黏貼表 </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: 99pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <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; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">批次製造紀錄 </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: 99pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </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: 56.25pt; background-color: transparent; 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border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <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; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">有效成分檢驗規格與方法及成績書二份 </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; 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border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <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; border-left: windowtext 1pt solid; 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border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <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; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">安定性試驗書面作業程序及其檢驗報告 </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: 99pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <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; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">採用證明＊1</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: 99pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">△ </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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">△ </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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">△ </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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">△ </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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">△ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <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; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">出產國許可製售證明（輸入）、處方依據（國產） </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: 99pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> </tr> <tr style="height: 10.75pt; page-break-inside: avoid;"> <td valign="top" style="height: 10.75pt; 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: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">委託書（輸入藥品） </span></p> </td> <td valign="top" style="height: 10.75pt; 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: 99pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 10.75pt; 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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 10.75pt; 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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 10.75pt; 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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 10.75pt; 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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> </tr> <tr style="height: 5.75pt; page-break-inside: avoid;"> <td valign="top" style="height: 5.75pt; 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: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">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: 5.75pt; 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: 99pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 5.75pt; 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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 5.75pt; 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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 5.75pt; 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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 5.75pt; 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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> </tr> <tr style="height: 9.75pt; page-break-inside: avoid;"> <td valign="top" style="height: 9.75pt; 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: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">分析方法確效資料二份 </span></p> </td> <td valign="top" style="height: 9.75pt; 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: 99pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 9.75pt; 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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 9.75pt; 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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 9.75pt; 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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 9.75pt; 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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> </tr> <tr style="height: 5.5pt; page-break-inside: avoid;"> <td valign="top" style="height: 5.5pt; 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: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">關鍵性製程確效資料二份＊2</span></p> </td> <td valign="top" style="height: 5.5pt; 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: 99pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 5.5pt; 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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○<b> </b></span></p> </td> <td valign="top" style="height: 5.5pt; 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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 5.5pt; 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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 5.5pt; 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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> </tr> <tr style="height: 19.15pt; page-break-inside: avoid;"> <td valign="top" style="height: 19.15pt; 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: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">製程中所使用動物原料之原廠動物原料來源管制之標準作業程序及原料來源證明，或原廠出具於製程中未使用動物成分來源之證明 </span></p> </td> <td valign="top" style="height: 19.15pt; 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: 99pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 19.15pt; 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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 19.15pt; 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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 19.15pt; 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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 19.15pt; 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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> </tr> <tr style="height: 10.55pt; page-break-inside: avoid;"> <td valign="top" style="height: 10.55pt; 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: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-family: 標楷體;"><span style="font-size: 10pt;">送驗</span><span style="font-size: 10pt; layout-grid-mode: line;">＊4</span> </span></p> </td> <td valign="top" style="height: 10.55pt; 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: 99pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">△ </span></p> </td> <td valign="top" style="height: 10.55pt; 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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 10.55pt; 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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 10.55pt; 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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line;">╳ </span></p> </td> <td valign="top" style="height: 10.55pt; 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: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">△ </span></p> </td> </tr> <tr style="height: 6.3pt; page-break-inside: avoid;"> <td valign="top" style="height: 6.3pt; 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: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">技術性資料 </span></p> </td> <td valign="top" style="height: 6.3pt; 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: 324pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="5"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">依 附 件 七 之 規 定 檢 附 </span></p> </td> </tr> </tbody></table><p style="margin: 9pt -1.3pt 0pt 0cm; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">註：○表示須檢附該項目之資料。 △表示視個案而定。 Ｘ表示不須檢附。 </span></p><p style="layout-grid-mode: char; margin: 0cm 7.55pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">＊1採用證明之相關規定如下： </span></p><p style="layout-grid-mode: char; margin: 0cm 7.55pt 0pt 39.2pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">屬基因工程藥品（含生物相似性藥品）、疫苗類藥品、人用血漿藥品與過敏原藥品等四類生物藥品： </span></p><p style="layout-grid-mode: char; margin: 0cm 7.55pt 0pt 57.3pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">一、如出產國屬美、日、加拿大、澳洲、英國（第一組）及德、法、瑞典、瑞士、比利時（第二組）等十國中之一國，且已有類似（同來源、同成分）產品上市，則其出產國許可製售證明得替代採用證明。 </span></p><p style="layout-grid-mode: char; margin: 0cm 7.55pt 0pt 57.3pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">二、如出產國屬美、日、加拿大、澳洲、英國（第一組）及德、法、瑞典、瑞士、比利時（第二組）等十國中之一國，但無類似（同來源、同成分）產品上市，則領證前除應有出產國許可製售證明外，應有另一十大醫藥先進國之採用證明。 </span></p><p style="layout-grid-mode: char; margin: 0cm 7.55pt 0pt 57.3pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">三、如出產國非屬美、日、加拿大、澳洲、英國（第一組）及德、法、瑞典、瑞士、比利時（第二組）等十國中之一國，但已有類似（同來源、同成分）產品上市，則領證前除應有出產國許可製售證明外，應有另一十大醫藥先進國之採用證明。 </span></p><p style="layout-grid-mode: char; margin: 0cm 7.55pt 0pt 57.3pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">四、如出產國非屬美、日、加拿大、澳洲、英國（第一組）及德、法、瑞典、瑞士、比利時（第二組）等十國中之一國，且無類似（同來源、同成分）產品上市，則領證前除應有出產國許可製售證明外，應依現行規定補齊三國採用證明（即二組中各一國之採用證明或十國中之三國採用證明）。 </span></p><p style="layout-grid-mode: char; margin: 0cm 7.55pt 0pt 38.5pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">＊2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; margin: 0cm 7.55pt 0pt 38.5pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">＊3生物相似性藥品：指以生物技術衍生之生物藥品，於品質、安全及功效上，與原本作為參考並已獲得我國上市許可之生物藥品相似。 </span></p><p style="layout-grid-mode: char; margin: 0cm 7.55pt 0pt 38.5pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">＊4過敏原藥品，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> |
| 發佈日期 | 2013-12-03 |
| 附件檔案 | https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6095&type=0 |