Extension of Deadlines for GMP Certificate Submission Approved by EAEU

Mechanisms for resolving disagreements arising from the registration of pharmaceuticals have been addressed by the Expert Committee for Medicines, created under the auspices of the Eurasian Economic Commission. Discrepancies in benefit-risk assessment data presented in expert reports by reference and recognition states on two registration dossiers were discussed at the first meeting of the Committee, which was chaired by Viktor Nazarenko, Minister for Technical Regulation of the EEC.

The Expert Committee supported the EEC’s initiative regarding the Pharmacopoeia of the Eurasian Economic Union. It is assumed that pharmaceutical companies which previously received registration certificates under EAEU rules will have to switch to the Pharmacopoeia of the Eurasian Economic Union by January 1, 2026.

Draft amendments were approved to Decision No.93 of the Commission’s Council issued on November 3, 2016, which extend the deadline for the recognition of GMP of the EAEU member states as well as EAEU’s GMP until the end of 2025. These documents will be required for national re-registration of medicinal products or introducing amendments to their registration dossiers. The draft provides for mutual recognition of EAEU GMP certificates for foreign manufacturers by the authorized bodies of the EAEU member states during the national procedures regulating introduction of amendments to registration dossiers until December 31, 2025. 

The proposed solutions will enable pharmaceutical companies of EAEU member countries as well as foreign drug manufacturers, to implement procedures supporting the circulation of medicines in national markets until the end of 2025 as well as reduce production costs associated with their re-inspection by each of the EAEC countries; these measures will also ensure drug accessibility to consumers, and facilitate transition to the EAEU for manufacturers.

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