Manufacturers can provide, when registering medicines in the Eurasian Economic Union, national documents confirming compliance with GMP requirements before their expiration. This decision was made by the Council of the Eurasian Economic Commission.

A single deadline for filing applications for obtaining national GMP certificates in the states of the Union has been determined – until December 31, 2021. Thus, from 2022, all states of the Union will switch to the issuance of GMP certificates according to the Rules of Good Manufacturing Practice of the EEU following the results of production inspections.

Given that the validity of national certificates is three years, until December 31, 2024, manufacturers will have enough time to update GMP certificates in the Union format and plan the time for obtaining a new Union certificate.

In addition, the EEU Council decided to switch from January 1, 2023 to the union format of the GMP certificate when issuing certificates for medicines produced for export.

The decision of the EEU Council makes it possible to submit an abbreviated format of the registration dossier for medicinal products brought in accordance with the rules of the Union, provided that they remain in circulation only on the territory of one state. In this case, manufacturers can submit a dossier containing the first three modules, prepared in the national language. The presentation of modules 4 and 5 for such medicinal products is performed by the manufacturer if he has at his disposal the documents necessary for their formation.

Changes have been made to the form of registration certificate for a medicinal product related to the ability to indicate “in bulk” (products not packaged in consumer packaging) in the number of packages of a medicinal product. Such a change in the registration certificate will allow the Union pharmaceutical companies operating in an incomplete production cycle to import drugs into the territory of the EEU for their subsequent packaging.

Source: TKS