The decision on the approval of the common rules was endorsed by the EEC Council on January 21, 2022. The decision will take effect 30 days after being officially published. The paragraph 1 of the decision which sets up the common rules for circulation of veterinary medicines within EAEU is effective 24 months after the document comes into force. Meaning that the common rules for circulation of veterinary drugs will take effect in 2024.
The new rules provide for:
- uniform procedure for registration of veterinary medicinal products;
- uniform requirements for the quality, efficiency and safety of veterinary medicines;
- uniform rules and procedures for control and oversight activities related to circulation of veterinary medicinal products.
Reminder – the mutual recognition of veterinary drugs registration applies within the territory of the EAEU since 2010. Meaning, that the product registered in Kazakhstan should be recognized in Russia as well. However, the five EAEU member countries have different laws regulating circulation of veterinary medicines, and the general approach to the assessment of product quality, efficiency and safety also differs. For instance, about 30% of veterinary drugs registered in 2019 in Kazakhstan had quality issues revealed by Rosselkhoznadzor.
The adopted rules, experts believe, will create a single market space for the manufacturers of veterinary medicinal products and provide for decrease in the number of adulterated and counterfeit products in the market.
The EEC Council defined transitional periods for the new rules to come into force. Thus, the procedure for registration of veterinary medicines in accordance with the national legislation of EAEU member countries is preserved until December 31, 2027. However, such products will be authorized for sale only within the territory of the country that issued the registration certificate, which in its turn will be valid until December 31, 2032. All registration certificates issued before the common rules come into force are effective until December 31, 2027. By that date all registration dossiers should be brought into line with the new rules.
