Important changes in the conduct of pharmaceutical inspections of veterinary manufacturers in accordance with the EAEU Rules

At the end of last year, the third version of the draft amendments to the EEC Council Decision of January 21, 2022 No. 1 (hereinafter referred to as the EAEU Rules), regulating the circulation of veterinary medicinal products within the Union, has been published on the official portal of the Eurasian Economic Union.

The key innovation was the decision to extend the transition period for registration and compliance of medicines dossiers with the EAEU Rules by three years – until December 31, 2030.

The new version includes several important changes in the conduct of pharmaceutical inspections in accordance with the EAEU Rules when issuing EAEU GMP certificates, in particular:

• Remote pharmaceutical inspections can be conducted, particularly in the event of circumstances that pose a threat to the life and health of pharmaceutical inspectors (e.g., political, medical, or other reasons) and that prevent the entire inspection team from participating in the pharmaceutical inspection. Once the circumstances that necessitated the remote pharmaceutical inspection have been resolved, the next pharmaceutical inspection is conducted as an on-site inspection (§ 325¹).
• A new certificate may be issued to replace a previously issued one in the event of a change in the manufacturing site address during the validity period of the issued certificate; a change in the manufacturer’s name during the validity period of the issued certificate; or the identification of technical errors in the certificate (A 26, § 3¹). A new certificate shall be issued with the expiration date of the previously issued one and provided that veterinary medicinal products are manufactured at the same manufacturing units and in the same production facilities, and that the dosage forms and manufacturing operations specified in the previously issued certificate are maintained at the same manufacturing site (§ 3² of A26).
• The opportunity to submit missing information and (or) documents to the competent authority in the event of incompleteness of the information contained in the GMP-application and (or) submitted documents or failure to submit documents (§ 6 of A26).
• The possibility of receiving an inspection program by the inspected entity no later than 20 working days before the start of the inspection (§ 17 of A26). Note: in the current version of the EAEU Rules – no later than 10 working days.
• If any non-conformities are identified during the inspection, a draft CAPA plan should be submitted to the competent authority that organized the inspection for approval no later than 30 calendar days from the date of receipt of the report. Note: the deadline for approval of the CAPA plan by the competent authority is currently unknown. The deadline for submitting a report on the implementation of the CAPA plan, along with supporting documentation, to the competent authority will be 60 calendar days from the date of approval (§ 28 of A26). Note: in the current version of the EAEU Rules – no later than 80 calendar days from the date of receipt of the report).
• The organization of a follow-up (control) inspection of the manufacturer is carried out at the initiative of the inspected entity of the circulation of veterinary medicinal products (§ 29 of A26).

The date when these changes will come into force is still unknown.

As a reminder, GMP inspections of medicinal product manufacturers are conducted for compliance with the requirements of the Good Manufacturing Practice Rules of the Eurasian Economic Union, approved by the EEC Council Decision of November 3, 2016 No. 77 (EAEU GMP Rules). The provisions of these Rules concerning the requirements for the manufacture of veterinary medicinal products entered into force on January 1, 2021.

The Russian competent authority (Rosselkhoznadzor) currently carries out GMP inspections of foreign manufacturers of veterinary medicinal products in accordance with Russian Government Decree of December 3, 2015 No. 1314 (note: this Decree will cease to be effective on March 1, 2026, in accordance with Russian Government Decree of November 8, 2025 No. 1766). Starting March 1, 2026, Rosselkhoznadzor plans to begin conducting pharmaceutical inspections in accordance with the EAEU Rules. Last October, the “Register of pharmaceutical inspectors of the veterinary pharmaceutical inspectorate of the Russian Federation” was posted on the Rosselkhoznadzor website. That same month, the Russian Government adopted Decree of October 29, 2025 No. 1681 “On establishing the fee for issuing certificates (conclusions) of conformity of the manufacture of veterinary medicinal products with the requirements of the EAEU GMP Rules.”

This year we can expect to see several more inspection related documents, such as the Order on empowering Rosselkhoznadzor to issue EAEU GMP certificates to manufacturers of veterinary medicinal products, the Order on approving the methodology for calculating the maximum fee for providing services for inspecting manufacturers of veterinary medicinal products in accordance with the EAEU Rules, and others.