Regulations of the Lot Release Procedures for Biologics Article 7
Biologics for emergency medical use, pharmaceutical firms may submit an undertaking statement from an attending physician in a district or higher level hospital or submit an application from the hospital, to apply for necessary amounts for emergency release.The biologics in the preceding paragraph, after the central competent health authority review the certificate of analysis from the original manufacturer, can be released with the emergency release seal attached to each container of the biologics in the applied amount.The undertaking statement or application in the first paragraph shall list the name of the drugs that patients need, the reason of usage and the amount.Pharmaceutical firms shall keep the information associated with the lot number of the biologics for emergency use, the users and the amount, for future reference.
中文原文 生物藥品檢驗封緘作業辦法第7條
因應緊急醫療需要之生物藥品，藥商得檢附地區醫院以上之主治醫師出具之切結書或醫院申請書，向中央衛生主管機關申請緊急放行所需要之數量。
前項生物藥品，經中央衛生主管機關審查其原廠檢驗成績書後，即得於所申請放行數量之生物藥品包裝上個別加貼緊急放行證，逕予放行；其餘未放行部分應續行辦理檢驗封緘作業。
第一項之切結書或申請書應載明病患急需使用之藥品名稱、使用理由及數量。
藥商應將緊急放行生物藥品之批號、供應對象及數量等資料保存備查。
前項生物藥品，經中央衛生主管機關審查其原廠檢驗成績書後，即得於所申請放行數量之生物藥品包裝上個別加貼緊急放行證，逕予放行；其餘未放行部分應續行辦理檢驗封緘作業。
第一項之切結書或申請書應載明病患急需使用之藥品名稱、使用理由及數量。
藥商應將緊急放行生物藥品之批號、供應對象及數量等資料保存備查。