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| 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〉附件二：生物藥品封緘證明書 |
| 條文內容 | <p style="margin: 0cm 0cm 0pt;" class="MsoNormal"><span lang="EN-US"><o:O:P><span style="font-family: arial unicode ms;"><table style="border-collapse: collapse;" border="1" cellspacing="0" cellpadding="0" width="622"> <tbody> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 466.2pt; padding-right: 5.4pt; padding-top: 0cm;border: rgb(0,0,0) 0px;" valign="top" colspan="2"> <p><span style="font-family: 標楷體; font-size: 18px;">附件二、生物藥品封緘證明書 </span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> <td style="background-color: transparent; width: 0px;border: rgb(0,0,0) 0px;"> <p><span style="font-size: 18px;"> </span></p> </td> <span style="font-size: 18px;"></span> </tr> <span style="font-size: 18px;"></span> <tr style="height: 42pt;"> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 466.2pt; padding-right: 5.4pt; height: 42pt; padding-top: 0cm;border: rgb(0,0,0) 0px;" valign="top" rowspan="2" colspan="2"><span style="font-size: 18px;"></span> <p style="text-align: center;"><span style="font-size: 18px;"><span style="font-family: arial unicode ms; text-decoration: none;"> </span><span style="font-family: 標楷體; text-decoration: underline;">行政院衛生署食品藥物管理局 </span> </span></p> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 18px;">生物藥品封緘證明書 </span></p> <span style="font-size: 18px;"></span> <p style="text-align: center;"><span style="font-size: 18px;"> <span style="font-family: 標楷體; text-decoration: underline;">FDA</span><span style="font-family: 標楷體; text-decoration: underline;">研字第OOOOOOOOOO號 </span></span></p> <span style="font-size: 18px;"></span> <p><span style="font-family: arial unicode ms; font-size: 18px; text-decoration: none;"> </span></p> <span style="font-size: 18px;"></span> <p><span style="font-family: arial unicode ms; font-size: 18px; text-decoration: none;"> </span></p> <span style="font-size: 18px;"></span> <div style="text-align: center;"><span style="font-size: 18px;"></span> <table style="border-collapse: collapse;" border="0" cellspacing="0" cellpadding="0"> <span style="font-size: 18px;"></span> <tbody> <tr> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 64.1pt; padding-right: 5.4pt; padding-top: 0cm;border: rgb(0,0,0);" valign="top"><span style="font-size: 18px;"></span> <p style="text-align: left;" class="a"><span style="font-size: 18px;"><span style="font-family: 標楷體; font-size: 12pt; text-decoration: underline;">申請廠商</span><span style="font-size: 12pt; text-decoration: underline;">:</span></span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 282.05pt; padding-right: 5.4pt; padding-top: 0cm;border: rgb(0,0,0);" valign="top"><span style="font-size: 18px;"></span> <p class="a"><span style="font-size: 18px; text-decoration: underline;">OOO</span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> </tr> <span style="font-size: 18px;"></span> <tr> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 64.1pt; padding-right: 5.4pt; padding-top: 0cm;border: rgb(0,0,0);" valign="top"><span style="font-size: 18px;"></span> <p style="text-align: left;" class="a"><span style="font-size: 18px;"><span style="font-family: 標楷體; font-size: 12pt; text-decoration: underline;">製劑名稱</span><span style="text-decoration: underline;"> </span></span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 282.05pt; padding-right: 5.4pt; padding-top: 0cm;border: rgb(0,0,0);" valign="top"><span style="font-size: 18px;"></span> <p><span style="font-size: 18px; text-decoration: underline;">OOO</span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> </tr> <span style="font-size: 18px;"></span> <tr> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 64.1pt; padding-right: 5.4pt; padding-top: 0cm;border: rgb(0,0,0);" valign="top"><span style="font-size: 18px;"></span> <p style="text-align: left;" class="a"><span style="font-size: 18px;"><span style="font-family: 標楷體; font-size: 12pt; text-decoration: underline;">製造廠名</span><span style="text-decoration: underline;"> </span></span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 282.05pt; padding-right: 5.4pt; padding-top: 0cm;border: rgb(0,0,0);" valign="top"><span style="font-size: 18px;"></span> <p><span style="font-size: 18px; text-decoration: underline;">OOO</span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> </tr> <span style="font-size: 18px;"></span> <tr> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 64.1pt; padding-right: 5.4pt; padding-top: 0cm;border: rgb(0,0,0);" valign="top"><span style="font-size: 18px;"></span> <p style="text-align: left;" class="a"><span style="font-size: 18px;"><span style="font-family: 標楷體; font-size: 12pt; text-decoration: underline;">批號</span><span style="font-size: 12pt; text-decoration: underline;">:</span></span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 282.05pt; padding-right: 5.4pt; padding-top: 0cm;border: rgb(0,0,0);" valign="top"><span style="font-size: 18px;"></span> <p><span style="font-size: 18px; text-decoration: underline;">OOO</span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> </tr> <span style="font-size: 18px;"></span> <tr> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 64.1pt; padding-right: 5.4pt; padding-top: 0cm;border: rgb(0,0,0);" valign="top"><span style="font-size: 18px;"></span> <p style="text-align: left;" class="a"><span style="font-size: 18px;"><span style="font-family: 標楷體; font-size: 12pt; text-decoration: underline;">有效日期</span><span style="font-size: 12pt; text-decoration: underline;">:</span></span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 282.05pt; padding-right: 5.4pt; padding-top: 0cm;border: rgb(0,0,0);" valign="top"><span style="font-size: 18px;"></span> <p><span style="font-size: 18px; text-decoration: underline;">OOO</span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> </tr> <span style="font-size: 18px;"></span> <tr> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 64.1pt; padding-right: 5.4pt; padding-top: 0cm;border: rgb(0,0,0);" valign="top"><span style="font-size: 18px;"></span> <p style="text-align: left;" class="a"><span style="font-size: 18px;"><span style="font-family: 標楷體; font-size: 12pt; text-decoration: underline;">包裝</span><span style="font-size: 12pt; text-decoration: underline;">:</span></span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 282.05pt; padding-right: 5.4pt; padding-top: 0cm;border: rgb(0,0,0);" valign="top"><span style="font-size: 18px;"></span> <p><span style="font-size: 18px; text-decoration: underline;">OOO</span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> </tr> <span style="font-size: 18px;"></span> <tr> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 64.1pt; padding-right: 5.4pt; padding-top: 0cm;border: rgb(0,0,0);" valign="top"><span style="font-size: 18px;"></span> <p style="text-align: left;" class="a"><span style="font-size: 18px;"><span style="font-family: 標楷體; font-size: 12pt; text-decoration: underline;">封緘數量</span><span style="font-size: 12pt; text-decoration: underline;">:</span></span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 282.05pt; padding-right: 5.4pt; padding-top: 0cm;border: rgb(0,0,0);" valign="top"><span style="font-size: 18px;"></span> <p><span style="font-size: 18px; text-decoration: underline;">OOO</span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> </tr> <span style="font-size: 18px;"></span> <tr> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 64.1pt; padding-right: 5.4pt; padding-top: 0cm;border: rgb(0,0,0);" valign="top"><span style="font-size: 18px;"></span> <p style="text-align: left;" class="a"><span style="font-size: 18px;"><span style="font-family: 標楷體; font-size: 12pt; text-decoration: underline;">封緘劑量</span><span style="font-size: 12pt; text-decoration: underline;">:</span></span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 282.05pt; padding-right: 5.4pt; padding-top: 0cm;border: rgb(0,0,0);" valign="top"><span style="font-size: 18px;"></span> <p><span style="font-size: 18px; text-decoration: underline;">OOO</span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> </tr> <span style="font-size: 18px;"></span> </tbody> </table> <span style="font-size: 18px;"></span></div> <span style="font-size: 18px;"></span> <p style="margin-left: 6pt;"><span style="font-size: 18px;"><span style="font-family: 標楷體; text-decoration: underline;">上述生物藥品之封緘檢驗案，符合生物藥品檢驗封緘作業之規定，予以封緘，此證。</span><span style="text-decoration: underline;"> </span></span></p> <span style="font-size: 18px;"></span> <p style="text-align: center;"><span style="font-family: arial unicode ms; font-size: 18px; text-decoration: none;"> </span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> <td style="background-color: transparent; width: 0px; height: 42pt;border: rgb(0,0,0) 0px;"></td> <span style="font-size: 18px;"></span> </tr> <span style="font-size: 18px;"></span> <tr style="height: 42pt;"> </tr> <span style="font-size: 18px;"></span> <tr style="height: 42pt;"> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 233.1pt; padding-right: 5.4pt; height: 42pt; padding-top: 0cm;border: rgb(0,0,0) 0px;" valign="top"><span style="font-size: 18px;"></span> <p style="text-align: center;"><span style="font-size: 18px;"><span style="font-family: 標楷體; text-decoration: underline;">局長 </span><span style="font-family: 標楷體; text-decoration: underline;">○○○</span><span style="text-decoration: underline;"> </span></span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 233.1pt; padding-right: 5.4pt; height: 42pt; padding-top: 0cm;border: rgb(0,0,0) 0px;"><span style="font-size: 18px;"></span> <p style="text-align: center;"><span style="font-family: arial unicode ms; font-size: 18px; text-decoration: none;"> </span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> <td style="background-color: transparent; width: 0px; height: 42pt;border: rgb(0,0,0) 0px;"></td> <span style="font-size: 18px;"></span> </tr> <span style="font-size: 18px;"></span> <tr style="height: 42pt;"> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 466.2pt; padding-right: 5.4pt; height: 42pt; padding-top: 0cm;border: rgb(0,0,0) 0px;" valign="top" colspan="2"><span style="font-size: 18px;"></span> <p style="text-align: center;"><span style="font-family: arial unicode ms; font-size: 18px;"> </span></p> <span style="font-size: 18px;"></span> <p style="text-align: center;"><span style="font-family: arial unicode ms; font-size: 18px;"> </span></p> <span style="font-size: 18px;"></span> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 18px;">中華民國 年 月 日 </span></p> <span style="font-size: 18px;"></span> <p style="text-align: center;"><span style="font-family: arial unicode ms; font-size: 18px;"> </span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> <td style="background-color: transparent; width: 0px; height: 42pt;border: rgb(0,0,0) 0px;"></td> <span style="font-size: 18px;"></span> </tr> <span style="font-size: 18px;"></span> </tbody></table><p style="margin: 0cm 0cm 0pt;" class="MsoNormal"> </p></span><p style="margin: 0cm 0cm 0pt;" class="MsoNormal"> </p></o:O:P></span></p> |
| 發佈日期 | 2013-12-03 |
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