New powers of the Authority
According to the signed document, the Federal Service for Veterinary and Phytosanitary Surveillance (Rosselkhoznadzor) is now officially responsible for:
- Organizing and conducting pharmaceutical inspections of veterinary medicine production facilities for compliance with the EAEU Good Manufacturing Practice (GMP) Rules.
- Issuing, suspending, renewing, and terminating EAEU GMP certificates (conclusions), as well as amending them.
- Establishing the procedure for maintaining and managing the state register of such certificates.
- Approving the certification procedure for pharmaceutical inspectors who will conduct inspections of manufacturing sites.
Transition to unified EAEU Rules
As a reminder, the legal procedure for issuing EAEU GMP certificates began in Russia on March 1. This is a critical step in the industry’s transition to operating under unified Eurasian legislation (in accordance with the Rules approved by Decision No. 1 of the EEC Council dated January 21, 2022). Previously, the very concept of a “GMP certificate” for veterinary medicines was first introduced by Federal Law No. 304-FZ dated July 31, 2025 (prior to this, “conclusions of conformity” were issued).
A state fee of 23,300 rubles has been established for issuing the document (in accordance with Russian Government Resolution No. 1681), but the cost of the inspection service itself will continue to be calculated individually for each site. Furthermore, the previous Russian Government Resolution No. 1314, which previously regulated these processes, has been repealed.
For manufacturers from third countries (outside the EAEU), inspections will be joint and conducted with notification to all Union Member States. Only after completing the initial joint inspections and receiving certificates will companies be able to submit applications for registration of new medicines or for aligning existing medicine dossiers with EAEU requirements.
Expert assessments
AVPHARM Executive Director Semion Zhavoronkov noted that such inspections can take a long time:
«It’s difficult to say yet how the joint inspection process will be organized and how long it will last – there are no precedents yet. But based on the existing procedure and the extensive practice of Russian GMP inspections abroad, it’s unlikely to be less than 200 calendar days per manufacturing site. We shared these statistics at the GMP Conference last year.»
