On September 15-17, 2025, the X All-Russian GMP Conference is being held in Moscow, organized by the Ministry of Industry and Trade of Russia together with the FSI “SID & GP”.                                         

Among other events, on the first day of the Сonference, authorized government bodies and industry associations held a panel session “EAEU’s common market of medicinal products for veterinary use”. The session was moderated by Timur Chibilyaev, Executive Director of the National Veterinary Association.

Anna Babushkina, Deputy Head of the Department for the Organization of State Veterinary Supervision of Rosselkhoznadzor, concluded her presentation by saying that from March 1, 2026, the Russian regulator will be able to begin conducting pharmaceutical inspections in accordance with the EAEU Rules with the issuance of GMP certificates (Appendix No. 26 to the Decision of the EEC Council of 21.01.2022 No. 1 “On the Rules for regulating the circulation of veterinary medicinal products in the customs territory of the Eurasian Economic Union”). This is since by this date, amendments to the Federal Law of 12.04.2010 No. 61-FZ “On the circulation of medicines”, adopted by the Federal Law of 31.07.2025 No. 304-FZ “On amendments to certain legislative acts of the Russian Federation”, must come into force in the Russian Federation.

In addition, the speaker noted that confirmation of licensees’ compliance with the EAEU GMP Rules can now be carried out within the framework of licensing, including periodic confirmation of the manufacturer’s compliance with licensing requirements, in accordance with Russian legislation.

The Advisor to the Director of the FSBI “VGNKI” Danil Rudniaev said that the number of Russian inspections is already showing signs of reaching a plateau; this year, there has been a reduction in the number of sites that have applied for inspection.

At the present time, the staff of the pharmaceutical inspectorate of the institution is 11 people and with this number they successfully cope with the inspections. All inspectors were certified by the internal procedure of the commission chaired by the representative of Rosselkhoznadzor and soon they will be included in the unified register of pharmaceutical inspectors.

The speaker also drew the attention of manufacturers to the most frequently occurring non-compliances:

• during incoming control, the bioburden of the raw materials included in the composition of sterile medicinal products is not checked;
• the number of reference samples of finished products is insufficient to permit the carrying out two occasions of the full analytical controls for all quality indicators;
• thermal mapping of warehouse premises is carried out without taking into account seasonality; loggers for routine monitoring are not installed based on the results of thermal mapping;
• when qualifying equipment, tests are not carried out at operating parameters equal to the upper and lower permissible limits;
• integrity testing of vials with sterile products is not carried out;
• primary packaging of parenteral products is not inspected for the presence of sub-visible particles;
• no particle monitoring is carried out during assembly and adjustment of equipment in areas where sterile medicinal products are produced;
• no control is carried out over the conformity of the information contained on printed materials for medicinal products intended for the Russian Federation;
• quality control (testing) methods are not validated;
• decontamination procedures for accidental spillages of liquids containing live microorganisms during the production of immunological medicinal products have not been validated;
• the routine process of aseptic filling of medicinal products is carried out by operators who have not participated in the Media Fill Test for more than a year;
• when performing aseptic operations, microbiological monitoring is not carried out by all the provided methods.

The Executive Director of the Association of Veterinary Pharmaceutical Manufacturers (AVFARM) Semion Zhavoronkov presented some questions received by AVFARM from manufacturers of veterinary medicines:

1. Practical implementation of the joint inspection mechanism – when will the first inspections take place under Appendix No. 26 to the EAEU Rules?
2. How will the mechanism for concluding an agreement(s) with inspectorates be implemented: calculation of the cost of inspection, the procedure for concluding agreements?
3. Is it possible to extend the time allotted for preparing the CAPA plan?*
   according to RF Government Decree No. 1314 – 60 working days (3 months), according to Appendix No. 26 to the EAEU Rules – 80 calendar days (2.6 months)
4. Timeframe for the inspection: is it possible to set a deadline for the joint inspection from the moment the decision is made?

Besides this, Timur Chibilyaev, Director of the Veterinary Department of the Ministry of Agriculture of Russia Maria Novikova, Deputy Director of the Department of Sanitary, Phytosanitary and Veterinary Measures of the EEC Vladimir Subbotin and Head of the Quality Assurance Department of the FSE “Stavropol Biofactory” Olga Sorochinskaya spoke at the session.