3rd Package of Amendments to EAEU Rules Now in Effect
On April 24, the third package of amendments to Decision No. 1 of the Council of the Eurasian Economic Commission (EEC) dated January 21, 2022 entered into force. The amendments concern the Rules governing the circulation of veterinary medicinal products in the customs territory of the Eurasian Economic Union (the “EAEU Rules”).
The key change is the extension of the transitional period by three years, until December 31, 2030. During this period, previously issued marketing authorisations for veterinary medicinal products will continue to be recognised throughout the Union. In order for such products to remain on the EAEU market after the end of the transitional period, their dossiers will need to be harmonized with the EAEU Rules. During the transitional period, the EAEU Member States will also be able to complete the implementation of any outstanding procedures into their national legislation.
In addition, the updated version of the EAEU Rules reflects many proposals put forward by the Russian and international business community, including:
- the possibility to retain the existing EAEU-wide recognition of marketing authorisations amended after March 13, 2024 (for example, due to mandatory digital labelling (track-and-trace) requirements or prescription-only status);
- the possibility to conduct GMP audits remotely;
- amendments to Clauses 102 and 208 concerning the circulation of veterinary medicinal products that have already been registered or whose registration dossiers have been harmonized with the EAEU Rules.
Amended EAEU Rules (in Russian)
3,23 Мб
Image by the EEC press service
