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EEC's Expert Committee for Medicinal Products determined deadlines for enacting Union's Pharmacopoeia and approved extending deadlines for submitting GMP certificates

EEC's Expert Committee for Medicinal Products determined deadlines for enacting Union's Pharmacopoeia and approved extending deadlines for submitting GMP certificates

7/2/2020

The first meeting of the Expert Committee for Medicinal Products at the Eurasian Economic Commission, chaired by Viktor Nazarenko, EEC Minister in charge of Technical Regulation, has considered mechanisms for resolving disputes arising during the registration of pharmaceuticals. Discrepancies in the benefit-risk assessment in expert reports of the reference State and the recognizing States for two master files have been discussed.

 The Expert Committee has endorsed the Commission's initiative on the Eurasian Economic Union's Pharmacopoeia. It is expected that medicinal product manufacturers that previously received marketing authorizations according to the Union's rules will have to switch to the Eurasian Economic Union's Pharmacopoeia until January 1, 2026.

 The draft amendments to Decision No. 93 of the Commission's Council dated November 3, 2016 were approved as well to extend the deadlines for recognizing the Union countries' GMP and the Union’s GMP for submitting these documents during national re-registration and making amendments to the pharmaceutical's master file until the end of 2025. The document contemplates mutual recognition of the Union's GMP certificates for foreign manufacturers by the EAEU countries' authorized authorities when implementing national procedures related to amending master files until December 31, 2025.

 The proposed decisions will allow the Union countries’ pharmaceutical enterprises and foreign pharmaceutical manufacturers to implement procedures supporting the medicines circulation in national markets until the end of 2025, reduce production costs associated with their repeated inspection by each of the EAEU countries, ensure that pharmaceuticals are available to the population at any time and provide manufacturers with optimal conditions for transiting to the Union market.