Experts continue to discuss possible changes to the regulations governing veterinary drugs in the EAEU

On June 23, a working meeting of experts was held at the Russian Union of Industrialists and Entrepreneurs (RSPP) to discuss the following issues:

• transitional provisions of the Decision of the Council of the Eurasian Economic Commission of January 21, 2022 “On the Rules for regulating the circulation of veterinary medicinal products in the customs territory of the Eurasian Economic Union” (hereinafter referred to as the EAEU Rules) and the definitions of the EAEU Rules;
• the practice of handling veterinary medicinal products produced during the period of amendments and bringing the registration dossier into compliance with the requirements of the EAEU Rules, as well as confirmation of registration;
• improvement of Eurasian pharmacovigilance procedures;
• organization of pharmaceutical inspections in accordance with the requirements of the EAEU Rules;
• requirements for preclinical and clinical studies, bioequivalence requirements.

Representatives of federal executive bodies (the Ministry of Agriculture of Russia, Rosselkhoznadzor and the FSBI “VGNKI”), industry unions and associations (NVA, AVPHARM, SPZ, leading agro-industrial companies, and interested members of the RSPP Commission on the Agro-Industrial Complex and Food Security were invited to participate in this event.

At the beginning of the meeting, it was noted that the common position, from which all industry associations proceed, is that aspects requiring regulation should be set out in the EAEU Rules in a clear and transparent manner for all entities involved in the circulation of veterinary medicinal products.

The proposals relating to Appendix No. 26 to the EAEU Rules – “Rules for conducting pharmaceutical inspections” were as follows:

1. Supplement paragraph 6: in the event of incompleteness of the information contained in the application and/or submitted documents, or failure to submit documents, the authorized body shall notify the applicant of this within 5 working days to regulate the period of notification of the applicant.
2. Amend paragraph 14 to set the deadline for acceptance and examination of submitted documents – within 10 working days from the date of receipt of the application and documents, and to set the deadline for agreeing with the applicant on the timing of the inspection – within 20 working days.
3. In paragraph 28, set deadlines for the following procedures:
   • analysis and approval by the authorized body that organized the inspection of the draft CAPA plan (no later than 20 calendar days from the date of receipt of the draft CAPA plan);
   • sending a notification of approval of the CAPA plan (no later than 5 calendar days from the date of approval of the draft);
   • assessment of the CAPA plan and the report on its implementation by all inspection participants (the applicant, no later than 80 calendar days from the date of approval of the CAPA plan by the authorized body that organized the inspection, sends to this authorized body a report on the implementation of the CAPA plan materials confirming the fact of its implementation).
4. Supplement paragraph 30 with information that the report is sent to the inspected entity and to the authorized body of the Member State that organized the inspection no later than 5 calendar days from the date of its signing (like paragraph 27).

In addition, in paragraph 9 of the EAEU Rules, experts proposed changing the wording for the validity period of the GMP certificate: 3 years from the date of signing the final inspection report based on the results of the pharmaceutical inspection (repeat pharmaceutical inspection, if carried out).

It should be noted that this is not the first time a working meeting of experts has been held at this site. Pharmprom reported on a similar meeting last February. After the required time had passed, several expert proposals were implemented. The EEC Council adopted Decision No. 33 of February 24, 2026, to the EAEU Rules, which, among other things, added paragraph 3251 on the possibility of conducting remote inspections (without pharmaceutical inspectors visiting the facility). In Appendix No. 26 to the Rules, paragraph 31 was added on the possibility of replacing a GMP certificate (issuing a new certificate in place of a previously issued one), and the necessary amendments were made to paragraphs 6 and 17.