A draft Decree of the Government of the Russian Federation updating the regulatory framework in the field of veterinary drug production has been published on the Federal Portal of Draft Regulatory Legal Acts. The document was developed to implement new legal norms and harmonize Russian law with the standards of the Eurasian Economic Union (EAEU).
The text of the project is available at the link: Project ID 01/01/08-23/00141151.
New Powers of the Supervisory Authority
According to the document, changes are being made to the Regulations on the Federal Service for Veterinary and Phytosanitary Surveillance (Decree No. 327). From March 1, 2026, the agency’s functions will be strictly aligned with supranational standards.
Rosselkhoznadzor is granted the following powers:
- Issuance of EAEU GMP Certificates: The agency issues certificates (conclusions) of compliance of veterinary drug production with the requirements of the Good Manufacturing Practice Rules of the Eurasian Economic Union, and also suspends, resumes, or terminates the validity of such certificates.
- Inspections according to Union Standards: Organization and (or) conduct of pharmaceutical inspections of veterinary drug production for compliance with the requirements of the Good Manufacturing Practice Rules of the Eurasian Economic Union.
- Unified Registry: Establishing the procedure for maintaining and maintaining the state registry of certificates (conclusions) of compliance of veterinary drug production with the requirements of the Good Manufacturing Practice Rules of the Eurasian Economic Union.
Attestation of Inspectors
An important innovation will be the assignment of the personnel attestation function to Rosselkhoznadzor. The agency will approve the procedure for the attestation of pharmaceutical inspectors authorized to conduct pharmaceutical inspections of veterinary drug production.
Changes in the Ministry of Agriculture
In parallel, the Regulations on the Ministry of Agriculture of the Russian Federation (Decree No. 450) are being adjusted. The draft declares clause 5.2.25(29) to be no longer in force, which eliminates the duplication of functions and redistributes powers between the ministry and the supervisory service within the framework of the new regulatory model.
Effective Date
It is expected that the new rules will come into force on March 1, 2026. The implementation of powers will be carried out within the limits of the current staffing and budgets of Rosselkhoznadzor and the Ministry of Agriculture.
