"The EAEU rules are due to enter into force in 24 months from the date of approval of the decision," the EEC said in a statement.
The new rules aim to set out:
• common registration procedure for veterinary drugs;
• common requirements for quality, efficacy, safety, and assessment criteria of veterinary drugs;
• common rules and procedure for control and supervision of veterinary drugs circulation.
“The new rules aim to create more suitable conditions for the development and operation of the EAEU single market of veterinary medicines,” the Eurasian Economic Commission reported.
As a reminder, the EAEU has introduced the rules on mutual recognition of veterinary drugs registration on its territory since 2010. It means that if a drug is registered, for example, in Kazakhstan, this registration will be recognized by Russia.
Nevertheless, the five EAEU countries have different legislation on the circulation of veterinary drugs. In particular, they have different approaches to the assessment of quality, safety and efficacy of veterinary drugs. As an example, in Kazakhstan it is not required to test products of animal origin for the presence of residues of an antibacterial veterinary drug before applying for its registration. In Armenia, the Scientific Center for Assessment and Analysis of Food Safety Risks that was authorized to conduct assessments of immunobiological veterinary products including animal vaccines, did not have the necessary methodological approach and equipment.
“According to new rules, all manufacturers of veterinary drugs will have to follow requirements of a single market. Particularly, the quality and safety of veterinary drugs should be confirmed through studies conducted in compliance with the rules of Good Laboratory Practice. The transportation, storage and sale of veterinary drugs should comply with the principles of GxP (Good Pharmacy Practice), Tatyana Sevastyanova, the Deputy Executive Director of the National Veterinary Association said earlier in an interview with the Veterinary Medicine and Life.
According to her, the common rules will help to reduce the number of counterfeit and adulterated products on the market.
The EEC Council has introduced the transition periods before the new rules come into force.
1. The veterinary drugs should be registered in accordance with the legislation of the EAEU country before the new rules come into force on December 31, 2027. However, such veterinary drugs will be permitted for sale in country only if they have been approved by that country. The registration certificates for such veterinary drugs will be valid through December 31, 2032.
2. A registration certificate for a veterinary drug issued before the common rules came into force will be valid through December 31, 2027.
3. A registration dossier for a veterinary drug issued before the common rules came into force should be modified in compliance with the new rules by December 31, 2027.