Rules for organizing and conducting inspection of pharmaceutical manufacturers for compliance with GMP requirements have been changed
On May 29, Chairman of the Government of the Russian Federation Mikhail Mishustin signed Decree of the Government of the Russian Federation No. 789 amending the rules for inspecting drug manufacturers for compliance with the rules of Good Manufacturing Practice, as well as issuing certificaes on the compliance of the drug manufacturer with GMP standards.
In terms of emergence, occurrence and liquidation of an emergency situation and (or) when there is a threat of the spread of a disease that poses a danger to others, diseases and injuries resulting from exposure of harmful chemical, biological, radiation factors, under which an inspection of the manufacturer that includes inspection of the manufacturing site, it would be impossible, the certificate is issued for a period of 3 years, which starts from the day the inspection of the manufacturing site is completed according to the documents, including using remote communications, among which audio or video communications.
The validity of the certificate regarding medicinal products for human use which expire (have expired) from March 15 to December 31, 2020, is extended for 12 months from the day following the expiration date of such certificate. The decision of the authorized body to extend the validity of these certificates is posted on the official website of the authorized body on the Internet. Information on the relevant decision is also submitted within 5 business days from the date of its adoption into the State Register of Certificates on the manufacturer’s compliance with the requirements of the rules of Good Manufacturing Practice.
Resolution on amendments to the Rules for organizing and conducting inspections of manufacturers of medicines for compliance with the requirements…
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