Regulations of the Lot Release Procedures for Biologics｜第 6 條｜Food and Drug Administration｜Regulation｜In Force
衛生福利部｜v1.0
Last Amended: 2015-07-15
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.