Changes to the EAEU legislation

The terms of recognition of the national GMP and the union GMP during national renewal and variation procedures were extended until December 31, 2025 by theamendments to the Resolution No. 93 dated November 3, 2016.

● this will allow manufacturers to maintain the life cycle of products on the national markets until the end of 2025;

● reduce the costs associated with repeated inspections by each EAEU country;

● ensure the availability of medicines, as well as smooth transition to the new Union requirements.

Also, on September 4, 2020, the Council of the Eurasian Economic Commission (EEC) approved amendments to the rules for bioequivalence studies of medicinal products.

Two additional annexes describe approaches for verification of the equivalent efficacy and interchangeability of locally applied medicinal products (ointments, gels and creams) and extended delayed-release tablets and capsules.

Contact us if you have any questions, as well as look for regulatory support on the EAEU territory and member states: