本站大部份資料在 2016 年後就未更新，若資料內無明確標示資料時間，請預設該資料為過時資料並斟酌使用，謝謝
| column | value |
|---|---|
| 類別 | 化學製造管制類,藥物製造/委託製造,生物藥品檢驗封緘作業辦法 |
| 法規性質 | 法規命令 |
| 法規名稱 | 〈生物藥品檢驗封緘作業辦法〉附件一：生物藥品檢驗封緘申請書 |
| 條文內容 | <pre><span style="font-family: "times new roman","serif"; font-size: 14pt; mso-fareast-font-family: 標楷體; mso-font-kerning: 1.0pt; mso-bidi-font-family: 'courier new'; mso-bidi-font-size: 10.0pt;" lang="EN-US"><o:O:P><span style="font-family: 新細明體; font-size: 16px;"></span> <table style="border-collapse: collapse; mso-table-layout-alt: fixed; mso-border-alt: solid windowtext .5pt; mso-yfti-tbllook: 480; mso-padding-alt: 0cm 5.4pt 0cm 5.4pt;" class="MsoTableGrid" border="1" cellspacing="0" cellpadding="0" width="622"><span style="font-family: 新細明體;"></span><tbody><tr style="mso-yfti-irow: 0; mso-yfti-firstrow: yes;"><span style="font-family: 新細明體;"></span><td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 466.2pt; padding-right: 5.4pt; padding-top: 0cm; mso-border-alt: solid windowtext .5pt;border: windowtext 1pt solid;" valign="top" colspan="7"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">附件一、生物藥品檢驗封緘申請書<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span></tr><span style="font-family: 新細明體;"></span><tr style="height: 33.4pt; mso-yfti-irow: 1;"><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 23.4pt; padding-right: 5.4pt; height: 33.4pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt;" valign="top" rowspan="3"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="margin: 0cm 0cm 0pt;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">申請廠商<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; height: 33.4pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" colspan="2"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">名稱<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 126pt; padding-right: 5.4pt; height: 33.4pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-align: right; text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">（蓋印）<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; height: 33.4pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" colspan="2"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">負責人<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 136.8pt; padding-right: 5.4pt; height: 33.4pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-align: right; text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">（簽章）<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span></tr><span style="font-family: 新細明體;"></span><tr style="height: 18.75pt; mso-yfti-irow: 2;"><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; height: 18.75pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" rowspan="2" colspan="2"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">地址<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 126pt; padding-right: 5.4pt; height: 18.75pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" rowspan="2"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體;" lang="EN-US"><o:O:P><span style="font-size: 16px;"> </span></o:O:P></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; height: 18.75pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" colspan="2"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">電話<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 136.8pt; padding-right: 5.4pt; height: 18.75pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體;" lang="EN-US"><o:O:P><span style="font-size: 16px;"> </span></o:O:P></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span></tr><span style="font-family: 新細明體;"></span><tr style="height: 18.75pt; mso-yfti-irow: 3;"><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; height: 18.75pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" colspan="2"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px; text-decoration: underline;">申請<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 136.8pt; padding-right: 5.4pt; height: 18.75pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px; text-decoration: underline;">封緘證明書：<span style="mso-spacerun: yes;" lang="EN-US"> </span>份<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-size: 16px;"><span style="font-family: 標楷體; text-decoration: underline;">放行證明（外銷用）：<span style="mso-spacerun: yes;" lang="EN-US"> </span>份</span><span style="font-family: 標楷體;" lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span></tr><span style="font-family: 新細明體;"></span><tr style="height: 1.8pt; mso-yfti-irow: 4;"><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 23.4pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt;" valign="top" rowspan="7"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: 0.05pt; margin: 0cm 0cm 0pt -1.55pt; mso-para-margin-left: -.13gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">申請檢驗封緘藥品<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" colspan="2"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">中文名稱<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 126pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體;" lang="EN-US"><o:O:P><span style="font-size: 16px;"> </span></o:O:P></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" colspan="2"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">藥品許可證字號<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 136.8pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體;" lang="EN-US"><o:O:P><span style="font-size: 16px;"> </span></o:O:P></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span></tr><span style="font-family: 新細明體;"></span><tr style="height: 1.8pt; mso-yfti-irow: 5;"><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" colspan="2"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">外文名稱<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 126pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體;" lang="EN-US"><o:O:P><span style="font-size: 16px;"> </span></o:O:P></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" colspan="2"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">批號<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 136.8pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體;" lang="EN-US"><o:O:P><span style="font-size: 16px;"> </span></o:O:P></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span></tr><span style="font-family: 新細明體;"></span><tr style="height: 1.8pt; mso-yfti-irow: 6;"><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" colspan="2"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">成分及單位含量<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 126pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體;" lang="EN-US"><o:O:P><span style="font-size: 16px;"> </span></o:O:P></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" colspan="2"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">有效日期<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 136.8pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體;" lang="EN-US"><o:O:P><span style="font-size: 16px;"> </span></o:O:P></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span></tr><span style="font-family: 新細明體;"></span><tr style="height: 1.8pt; mso-yfti-irow: 7;"><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" colspan="2"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">包裝<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 126pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體;" lang="EN-US"><o:O:P><span style="font-size: 16px;"> </span></o:O:P></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" colspan="2"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">貯存方法<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 136.8pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體;" lang="EN-US"><o:O:P><span style="font-size: 16px;"> </span></o:O:P></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span></tr><span style="font-family: 新細明體;"></span><tr style="height: 1.8pt; mso-yfti-irow: 8;"><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 54pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" rowspan="2"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">原製造廠<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 36pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">名稱<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 126pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體;" lang="EN-US"><o:O:P><span style="font-size: 16px;"> </span></o:O:P></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" colspan="2"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">進口日期<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 136.8pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">民國<span style="mso-spacerun: yes;" lang="EN-US"> </span>年<span style="mso-spacerun: yes;" lang="EN-US"> </span>月<span style="mso-spacerun: yes;" lang="EN-US"> </span>日<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span></tr><span style="font-family: 新細明體;"></span><tr style="height: 1.8pt; mso-yfti-irow: 9;"><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 36pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">地址<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 352.8pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" colspan="4"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體;" lang="EN-US"><o:O:P><span style="font-size: 16px;"> </span></o:O:P></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span></tr><span style="font-family: 新細明體;"></span><tr style="height: 1.8pt; mso-yfti-irow: 10;"><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 54pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: rgb(0,0,0) 0px; padding-top: 0cm; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-bottom-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-align: right; text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">進口<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-align: right; text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">製造<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 36pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-top-alt: solid windowtext .5pt; mso-border-bottom-alt: solid windowtext .5pt; mso-border-right-alt: solid windowtext .5pt;"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-justify: inter-ideograph; text-align: justify; text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">數量<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 126pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體;" lang="EN-US"><o:O:P><span style="font-size: 16px;"> </span></o:O:P></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 60pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm; mso-border-left-alt: solid windowtext .5pt;border: rgb(0,0,0) 0px;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-align: right; text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">封緘<span style="text-decoration: underline;"><span lang="EN-US">/</span>外銷<span lang="EN-US"><o:O:P></o:O:P></span></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-align: right; text-indent: -11pt; margin: 0cm 0cm 0pt 5pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-size: 16px;"><span style="font-family: 標楷體; font-size: 11pt; text-decoration: underline;">藥物檢查證</span><span style="font-family: 標楷體; font-size: 11pt;" lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: rgb(0,0,0) 0px; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 30pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-right-alt: solid windowtext .5pt;"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-justify: inter-ideograph; text-align: justify; text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">數量<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 136.8pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體;" lang="EN-US"><o:O:P><span style="font-size: 16px;"> </span></o:O:P></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span></tr><span style="font-family: 新細明體;"></span><tr style="height: 1.8pt; mso-yfti-irow: 11; mso-yfti-lastrow: yes;"><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 23.4pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -5.15pt; margin: 0cm 0cm 0pt -0.85pt; mso-char-indent-count: -.43; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-size: 16px;"><span style="font-family: 標楷體; mso-spacerun: yes;" lang="EN-US"> </span><span style="font-family: 標楷體;">應附資料文件<span lang="EN-US"><o:O:P></o:O:P></span></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 442.8pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" colspan="6"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-justify: inter-ideograph; text-align: justify; line-height: 18pt; text-indent: -13.5pt; margin: 0cm 0cm 0pt 13.5pt; vertical-align: baseline; mso-layout-grid-align: none; mso-list: l0 level1 lfo1;" class="MsoNormal"><span style="font-size: 16px;"><span style="mso-fareast-font-family: 'times new roman'; mso-list: ignore;" lang="EN-US">(1)</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman';">輸入包裝清單</span><span style="mso-fareast-font-family: 標楷體;" lang="EN-US">(Packing list)<span style="mso-spacerun: yes;"> </span>(</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman';">國產製品得免附</span><span style="mso-fareast-font-family: 標楷體;" lang="EN-US">)</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman';">。</span><span style="mso-fareast-font-family: 標楷體;" lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-justify: inter-ideograph; text-align: justify; line-height: 18pt; text-indent: -13.5pt; margin: 0cm 0cm 0pt 13.5pt; vertical-align: baseline; mso-layout-grid-align: none; mso-list: l0 level1 lfo1;" class="MsoNormal"><span style="font-size: 16px;"><span style="mso-fareast-font-family: 'times new roman'; mso-list: ignore;" lang="EN-US">(2)</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman';">生物藥品原產國國家檢驗機關之檢定合格證明</span><span style="mso-fareast-font-family: 標楷體;" lang="EN-US"><span style="mso-spacerun: yes;"> </span>(</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman';">國產製品得免附</span><span style="mso-fareast-font-family: 標楷體;" lang="EN-US">)</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman';">。</span><span style="mso-fareast-font-family: 標楷體;" lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-justify: inter-ideograph; text-align: justify; line-height: 18pt; text-indent: -13.5pt; margin: 0cm 0cm 0pt 13.5pt; vertical-align: baseline; mso-layout-grid-align: none; mso-list: l0 level1 lfo1;" class="MsoNormal"><span style="font-size: 16px;"><span style="mso-fareast-font-family: 'times new roman'; mso-list: ignore;" lang="EN-US">(3)</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman';">衛生署核發藥品許可證或核可文件之影本。</span><span style="mso-fareast-font-family: 標楷體;" lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-justify: inter-ideograph; text-align: justify; line-height: 18pt; text-indent: -13.5pt; margin: 0cm 0cm 0pt 13.5pt; vertical-align: baseline; mso-layout-grid-align: none; mso-list: l0 level1 lfo1;" class="MsoNormal"><span style="font-size: 16px;"><span style="mso-fareast-font-family: 'times new roman'; mso-list: ignore;" lang="EN-US">(4)</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman';">生物藥品之製程、檢驗方法、規格及有關文獻。</span><span style="mso-fareast-font-family: 標楷體;" lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-justify: inter-ideograph; text-align: justify; line-height: 18pt; text-indent: 15.7pt; margin: 0cm 0cm 0pt; vertical-align: baseline; mso-char-indent-count: 1.31; mso-layout-grid-align: none;" class="MsoNormal"><span style="font-size: 16px;"><span style="mso-fareast-font-family: 標楷體;" lang="EN-US">□</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman';">：各項原廠證明資料與查驗登記資料相符，請准免送。</span><span style="mso-fareast-font-family: 標楷體;" lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-justify: inter-ideograph; text-align: justify; line-height: 18pt; text-indent: -13.5pt; margin: 0cm 0cm 0pt 13.5pt; vertical-align: baseline; mso-layout-grid-align: none; mso-list: l0 level1 lfo1;" class="MsoNormal"><span style="font-size: 16px;"><span style="mso-fareast-font-family: 'times new roman'; mso-list: ignore;" lang="EN-US">(5)</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman';">動物原料來源管制之標準操作程序</span><span style="mso-fareast-font-family: 標楷體;" lang="EN-US">(SOP)</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman';">及原料來源證明。</span><span style="mso-fareast-font-family: 標楷體;" lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-justify: inter-ideograph; text-align: justify; line-height: 18pt; text-indent: 15.7pt; margin: 0cm 0cm 0pt; vertical-align: baseline; mso-char-indent-count: 1.31; mso-layout-grid-align: none;" class="MsoNormal"><span style="font-size: 16px;"><span style="mso-fareast-font-family: 標楷體;" lang="EN-US">□</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman';">：各項原廠證明資料與前次申請檢驗封緘資料相符，請准免送。</span><span style="mso-fareast-font-family: 標楷體;" lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-justify: inter-ideograph; text-align: justify; line-height: 18pt; text-indent: -13.5pt; margin: 0cm 0cm 0pt 13.5pt; vertical-align: baseline; mso-layout-grid-align: none; mso-list: l0 level1 lfo1;" class="MsoNormal"><span style="font-size: 16px;"><span style="mso-fareast-font-family: 'times new roman'; mso-list: ignore;" lang="EN-US">(6)</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman';">本批生物藥品製程之分裝數量紀錄與檢定紀錄及成品之檢定紀錄與成績書。</span><span style="mso-fareast-font-family: 標楷體;" lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-justify: inter-ideograph; text-align: justify; line-height: 18pt; text-indent: 15.7pt; margin: 0cm 0cm 0pt; vertical-align: baseline; mso-char-indent-count: 1.31; mso-layout-grid-align: none;" class="MsoNormal"><span style="font-size: 16px;"><span style="mso-fareast-font-family: 標楷體;" lang="EN-US">□</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman';">：</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman'; mso-hansi-font-family: 'times new roman';">因應防疫或外銷用生物藥品，</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman';">請准後補資料。（檢附同意函）</span><span style="mso-fareast-font-family: 標楷體; mso-hansi-font-family: 標楷體;" lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-justify: inter-ideograph; text-align: justify; line-height: 18pt; text-indent: 15.7pt; margin: 0cm 0cm 0pt; vertical-align: baseline; mso-char-indent-count: 1.31; mso-layout-grid-align: none;" class="MsoNormal"><span style="font-family: 標楷體;" lang="EN-US"><o:O:P><span style="font-size: 16px;"> </span></o:O:P></span></p><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-justify: inter-ideograph; text-align: justify; line-height: 18pt; text-indent: 15.7pt; margin: 0cm 0cm 0pt; vertical-align: baseline; mso-char-indent-count: 1.31; mso-layout-grid-align: none;" class="MsoNormal"><span style="font-family: 標楷體;" lang="EN-US"><o:O:P><span style="font-size: 16px;"> </span></o:O:P></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span></tr><span style="font-family: 新細明體;"></span><tr><span style="font-family: 新細明體;"></span><td style="background-color: transparent; width: 31px;border: rgb(0,0,0) 0px;"><span style="font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="background-color: transparent; width: 72px;border: rgb(0,0,0) 0px;"><span style="font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="background-color: transparent; width: 48px;border: rgb(0,0,0) 0px;"><span style="font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="background-color: transparent; width: 168px;border: rgb(0,0,0) 0px;"><span style="font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="background-color: transparent; width: 80px;border: rgb(0,0,0) 0px;"><span style="font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="background-color: transparent; width: 40px;border: rgb(0,0,0) 0px;"><span style="font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="background-color: transparent; width: 182px;border: rgb(0,0,0) 0px;"><span style="font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span></tr><span style="font-family: 新細明體;"></span></tbody></table></o:O:P></span><span style="font-family: "times new roman","serif"; font-size: 14pt; mso-fareast-font-family: 標楷體; mso-font-kerning: 1.0pt; mso-bidi-font-family: 'courier new'; mso-bidi-font-size: 10.0pt;" lang="EN-US"><o:O:P></o:O:P></span></pre> |
| 發佈日期 | 2013-12-03 |
| 附件檔案 | https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4487&type=0 |