New rules for the regulation of the veterinary drug market in the EAEU to take effect on March 13

veterinary drug market in the EAEU

The Veterinary Pharmaceutical Manufacturers Association has presented a concise summary of the changes affecting the veterinary drug market due to the implementation of the “Regulations on the circulation of veterinary medicinal products within the customs territory of the EAEU.” The existing mutual recognition of registrations will be replaced initially by two parallel procedures — national and common Eurasian — and after 2028, new drugs will only be registrable under the Eurasian procedure.

Under the Eurasian registration procedure, national and international manufacturers will be able to choose a reference country, whose authorized bodies will carry out the necessary actions according to mutually established rules. Veterinary drugs registered in this manner will be available across the entire EAEU space.

Within the framework of the Eurasian procedure, EAEU countries will adhere to common requirements regarding registration dossier materials, clinical and preclinical trials, the examination process, and the conduct of GMP inspections.

When registering under the Eurasian procedure, manufacturers can choose in which specific EAEU countries the veterinary drug will be marketed. Choosing the national procedure allows the drug to be marketed only within the territory of one country.

Dossiers for pet medicines already registered in EAEU countries must be brought into compliance with the Regulation requirements during the transition period.

Authorized national bodies of EAEU countries will create a unified register of registered veterinary drugs, develop storage systems, and implement automatic data exchange of registration dossiers.

In each EAEU country, national inspection bodies will be established to conduct independent inspections (for local manufacturers) and joint inspections (for manufacturers outside the EAEU), verifying compliance with EAEU GMP requirements. Specialists with the necessary qualifications will be included in a common EAEU inspector registry.

Some veterinary drug registrations will be cancelled in accordance with Annex No. 4, which lists drugs whose use will be prohibited or restricted. For example, the use of progesterone-based drugs for the synchronization of estrus in cattle will be prohibited.

Additionally, Kyrgyzstan will join the common veterinary medicinal products market of the EAEU.

The Veterinary Pharmaceutical Manufacturers Association was founded in 2020 as an association of leading veterinary medicinal product manufacturers. Its aim is to consolidate the positions of participants in the Russian veterinary drug market and to represent their interests in the governmental bodies of Russia and the EAEU. Current members of AVFARM include pharmaceutical companies such as MSD Animal Health, Boehringer Ingelheim, and Zoetis.

 

Photo: Freepik

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