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blue-check New procedures for inspection of GMP compliance of manufacturers

Decision No. 49/QD-BYT dated January 9th, 2023 of the Ministry of Health on announcement of superseding administrative procedures; annulled administrative procedure in the field of pharmacy under management of the Ministry of Health in Circular No. 12/2022/TT-BYT dated November 21, 2022 of the Ministry of Health on amendments to some articles of Circular No. 35/2018/TT-BYTstatus2 dated November 22, 2018 of the Ministry of Health on good manufacturing practices for pharmaceutical products and pharmaceutical starting materials
Posted: 10/1/2023 7:32:17 AM | Latest updated: 1/2/2023 2:45:40 PM (GMT+7) | LuatVietnam: 5621
VietlawOnline

This Decision is to replace 02 administrative procedures regulated at Circular No. 12/2022/TT-BYT, including:

1. Inspection of compliance with good manufacturing practices (GMP) for pharmaceutical products and pharmaceutical starting materials in case of changes specified in Points b, c or d Clause 2 Article 11 or in case the manufacturer of sterile pharmaceutical products and pharmaceutical starting materials makes changes specified in Point dd, e and g Clause 2 Article 11 of Circular No. 35/2018/TT-BYTstatus2 .

2. Declaration of compliance with EU-GMP standards and EU-GMP equivalence for the manufacturer.

This Decision takes effect from the date on which it is signed.

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Effective Date 9-Jan-2023
ExpiredDate Unknown

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vnflag pdficon QD49_09012023BYT.pdf
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