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-BYT .
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.