The Ministry of Industry and Trade of Russia has developed a draft order “On the extension of the validity of conclusions on the compliance of a manufacturer of medicines with the requirements of the rules of good manufacturing practice.” The project was developed in accordance with Decree of the Government of the Russian Federation dated March 12, 2022 No. 353 “On the specifics of licensing activities in the Russian Federation in 2022”.
The draft order proposes to extend the validity of conclusions on the compliance of a manufacturer of medicines with the requirements of the Good Manufacturing Practice (GMP) rules for 12 months from the day following the day of expiration of such conclusions. Such an extension will apply to opinions that expire between January 1 and December 31, 2022.
This measure will reduce the administrative burden on drug manufacturers in the context of the introduction of economic restrictive measures against the Russian Federation.
Source: Ministry of Industry and Trade