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Regulations of the Lot Release Procedures for Biologics - Article 5

Regulations of the Lot Release Procedures for Biologics｜第 5 條｜Food and Drug Administration｜Regulation｜In Force

衛生福利部｜v1.0

Last Amended: 2015-07-15

Content

The central competent health authority shall conduct reviewing and testing according to the type of sampled biologics, when necessary. Released biologics may be sold and supplied after receiving a Drug Approval Seal from the central competent health authority and attached to each container. The Certificate of Lot Release of Biologics (as per attachment 2) or the Lot Release Certificate (as per attachment 3) shall be issued by the central competent health authority to those pharmaceutical firms who apply for lot release.

Related Regulations - Regulations of the Lot Release Procedures for Biologics

• Regulations of the Lot Release Procedures for Biologics - Article 3（第 3 條）
• 酒製造業良好衛生標準 - Article 7（第 7 條）
• Regulations of the Lot Release Procedures for Biologics - Article 1（第 1 條）
• Regulations of the Lot Release Procedures for Biologics - Article 2（第 2 條）
• Regulations of the Lot Release Procedures for Biologics - Article 4（第 4 條）
• Regulations of the Lot Release Procedures for Biologics - Article 6（第 6 條）