Since July 1, 2021, new medicines in all EAEU countries are registered according to the same rules

Today, the pharmaceutical market pays special attention to the transitional period of registration of medicines within the framework of the Eurasian Economic Union.

The transition period is a process in which the registration of medicines is gradually carried out according to the unified requirements and rules of the EAEU.

Thus, according to the decision of the Council of the Eurasian Economic Commission (EEC), from July 1, 2021, applications for registration of new medicines are accepted by authorized bodies according to the rules of the Union.

At the same time, medicines that have already been registered and are in national registries will be applied until the end of 2025.

Thus, from January 1, 2026, all registration certificates for medicines issued under the national legislation of the EAEU member states will be canceled.

We add that the transition period for GMP has also been extended according to the EEC Council. The EEC Council has set a deadline for submitting applications for national GMP certificates in the EAEU countries until December 31, 2021, which will be valid until the expiration of their validity.

It follows from this that from 2022, all member states of the Union will switch to issuing GMP certificates according to the rules of good manufacturing practice of the EAEU based on the results of inspection of production facilities.