Regulations of the Lot Release Procedures for Biologics Article 6
In accordance with national epidemic control policy or in case of serious emergencies, or special medical purpose, biologics with approval of the central competent health authority, may be exempted from testing in the Article 5.The biologics in the preceding Paragraph may be sold and supplied after documents and temperature of transportation and storage of biologics comply with requirements, and the Drug Approval Seal has been attached with each container. The Certificate of Lot Release of Biologics or the Lot Release Certificate shall be issued by the central competent health authority to those pharmaceutical firms who apply for lot release.In the circumstances described in the preceding Paragraph, the central competent health authority may, when necessary, take samples of biologics to test for compliance with requirements.
中文原文 生物藥品檢驗封緘作業辦法第6條
配合國家防疫政策或因應緊急重大事件、特殊醫療需要之生物藥品，經中央衛生主管機關核可者，得不適用第五條有關檢驗之規定。
前項生物藥品，經中央衛生主管機關審查其申請資料及查核其運送與貯存之溫度符合貯藏條件後，並於其包裝上個別加貼藥物檢查證，始得販售、供應。
中央衛生主管機關並應核發生物藥品封緘證明書或外銷用生物藥品批次放行證明予申請封緘檢驗之藥商。
前項情形，中央衛生主管機關於必要時得抽驗其生物藥品或抽取適量生物藥品備查。
前項生物藥品，經中央衛生主管機關審查其申請資料及查核其運送與貯存之溫度符合貯藏條件後，並於其包裝上個別加貼藥物檢查證，始得販售、供應。
中央衛生主管機關並應核發生物藥品封緘證明書或外銷用生物藥品批次放行證明予申請封緘檢驗之藥商。
前項情形，中央衛生主管機關於必要時得抽驗其生物藥品或抽取適量生物藥品備查。