Laws Information

法規資訊
Title: Regulations of the Lot Release Procedures for Biologics
Am Date: 2015-07-15
Legislative History: Amended by the Ministry of Health and Welfare, No. 1041202578, on July 15, 2015; The Regulations shall be effective on the day of the publication

Transaction

Amended

Article 5
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.