EAEU Transition Period for Veterinary Products Extended to 2030. What Registration Holders Must Do Now
The veterinary market of the Eurasian Economic Union (EAEU) is operating under two different regulatory logics at the same time. Veterinary medicinal products (VMPs) registered before the unified rules came into force continue to circulate under national registration certificates. New products are already required to go through the unified Union procedure. Both have one common deadline: December 31, 2030.
By Decision of the EEC Council dated February 24, 2026, No. 33, the transition period was extended from 2027 to 2030. The market gained three additional years, and this decision has practical implications for holders of existing registrations. Let’s look at what has changed and what to do.
How Veterinary Product Registration Worked Before 2022
Each EAEU member state registered veterinary medicinal products independently. The Federal Service for Veterinary and Phytosanitary Surveillance (Rosselkhoznadzor), Kazakhstan’s authorized body, and Belarusian structures all applied their own requirements for dossier composition, expert review timelines, and the volume of clinical data. A product registered in Russia had no automatic right to circulate in Kazakhstan.
A manufacturer operating in all five EAEU member states was required to maintain five separate documentation packages. Requirements differed to such an extent that a product with full clinical justification under one set of standards might not satisfy the requirements of another regulator. Trade barriers within the Union were quite tangible.
Decision of the EEC Council dated January 21, 2022, No. 1, «On the Rules for Regulating the Circulation of Veterinary Medicinal Products in the Customs Territory of the Eurasian Economic Union,» changed this logic. The rules entered into force in 2024 (24 months after their adoption).
What Changed When the Unified Rules Came into Force
Decision No. 1 (as amended by Decision No. 33 of February 24, 2026) introduces a different regulatory system: a unified registration certificate, common dossier requirements, a mandatory GMP certificate, and pharmacovigilance.
Unified Registration Certificate. One EAEU registration certificate grants the right for a product to circulate throughout the entire customs territory of the Union: in Russia, Belarus, Kazakhstan, Armenia, and Kyrgyzstan. The registration number follows the format «VMP-EAEU-XXXXXX-YY,» where YY is the letter code of the reference state.
Reference Authority System. The applicant selects which country’s authorized body to file the application with. That body becomes the reference authority and manages the entire procedure. Other member states receive the documents, conduct their own expert review, and decide on the product’s circulation in their territory. If one of them refuses, the procedure for the others continues.
Mandatory EAEU GMP Certificate. Manufacturing must comply with the EAEU Rules of Good Manufacturing Practice, approved by Decision of the EEC Council dated November 3, 2016, No. 77. The certificate is issued for 3 years from the date of the final day of the pharmaceutical inspection. Without it, registration is not possible.
CTD Format. The registration dossier is compiled according to the Common Technical Document (CTD) structure: five modules covering administrative documents, expert summaries, and data on quality, safety, and efficacy.
Pharmacovigilance Requirements. The registration certificate holder is required to implement a system for collecting adverse reaction data and submit Periodic Safety Update Reports (PSUR) when confirming the registration.
Initial registration is granted for 5 years. After confirmation, the registration becomes indefinite (except for cases where one additional 5-year confirmation is designated).
Procedure Timelines
| Procedure | Standard Products | Products per Annex 8 |
|---|---|---|
| Initial Registration | 235 working days | 155 working days |
| Simplified Registration (Generics) | 180 working days | 95 working days |
| Registration Confirmation | 170 working days | 85 working days |
| Introduction of Changes (with sample analysis) | 225 working days | 140 working days |
The time taken by the applicant to respond to the regulator’s requests is not counted toward these timelines. The applicant has 90 working days to respond, or up to 180 in justified cases.
Transition Provisions: What is in Practice in 2026
Decision No. 33 of February 24, 2026, established several mechanisms that directly affect portfolio management.
National Registration Continues. Until December 31, 2030, products may still be registered under national legislation. Such a registration certificate is valid only in the territory of the country where it was issued, and for no more than 5 years.
Existing Registration Certificates Remain Valid Until 2030. Registration certificates issued before the EAEU Rules came into force, as well as those issued via national procedures after that date, are valid within the customs territory of the Union until December 31, 2030. This is directly established by the updated sub-clause «c» of paragraph 2 of Decision No. 1.
Changes to Existing Dossiers Are Now Governed by Clear Rules. Sub-clause «b(1)» was introduced separately: from March 13, 2024, registration confirmation and the introduction of changes to existing dossiers can be carried out under national legislation without the immediate conversion of the dossier into EAEU format. Previously, this ambiguity created risks for companies trying to update their documentation.
Dossier Alignment Deadline. By December 31, 2030, all national dossiers must be brought into compliance with the EAEU Rules. For products with indefinite or extended registration, the application must be submitted no later than 230 working days before the deadline — approximately April 2030. Given the expected workload on expert institutions, building in a larger buffer is advisable.
After January 1, 2031, incomplete registrations will be considered invalid. Products manufactured during the validity period of the registration certificate may be stored, transported, sold, and used until the expiration date indicated on the packaging. Manufacturing and import of new batches is prohibited from that moment.
Transitional GMP Certificates. Compliance documents issued under national standards before January 1, 2021, were recognized until December 31, 2025. Certificates issued under the EAEU GMP Rules (Decision No. 77) remain valid until the end of their term, but for no more than 3 years from the date of issue.
Special Categories of Products
Decision No. 1 identifies several categories with simplified transition conditions.
For products listed in Annex 8 (specific active substances from the established list), accelerated timelines apply: 155 working days instead of 235 for initial registration. The full list is contained in Annex 8 to the Rules.
For products listed in Annex 16 (a single active substance with a pharmacopeial monograph in the Pharmacopoeia of the EAEU), no dossier alignment procedure is required. The authorized body simply assigns a new EAEU registration number. For products listed in Annex 16(1), a simplified mutual recognition scheme applies — 130 working days instead of 220.
Immunobiological products (vaccines, toxoids, and sera) do not fall under the simplified procedure for generics and are subject to specific requirements for samples during expert review.
For products intended for food-producing animals (meat, milk, eggs, and aquaculture), maximum residue limits (MRL) for active substances and methods for their determination must be established in EAEU legal acts. If an MRL for a specific substance has not been established, registration cannot proceed until the completion of a special procedure for its introduction (paragraph 28 of Decision No. 1). This requirement links veterinary registration directly to food safety across the Union.
What to Do
Conduct a portfolio inventory. Divide your products into three groups: registered under EAEU procedures (in order), registered under national rules before 2024 (dossier alignment required), and registered under national rules after 2024 (valid for up to 5 years, but only in one country).
Check GMP certificate expiry dates. Without a valid certificate under the EAEU GMP Rules, a new registration cannot be filed. The certificate is valid for 3 years. If expiry is approaching, plan the inspection well in advance — queues for inspections are long.
Set priorities. Dossier alignment should be prioritized for products with steady sales volumes. For products with low commercial value, run the numbers: the cost of a CTD dossier and new studies may exceed the profits for the remaining period.
Allow at least 230 working days. The application for dossier alignment must be filed no later than April 2030. Earlier is better — expert institutions will predictably be overloaded in 2029–2030.
Open a dialogue with the reference authority. Before filing an application, pre-registration consultations with the authorized body or expert institution are possible. This helps clarify dossier requirements and avoids spending 90 days responding to a first request on straightforward questions.
Four years until the 2030 deadline may seem like a sufficient planning horizon. But the standard registration procedure takes up to 235 working days — not counting dossier preparation, the required studies, and the GMP inspection. Companies with large portfolios and manufacturing across multiple member states should start planning now.
Regulatory Framework:
1. Decision of the EEC Council dated January 21, 2022, No. 1, «On the Rules for Regulating the Circulation of Veterinary Medicinal Products in the Customs Territory of the Eurasian Economic Union» (as amended by Decisions of the EEC Council dated September 27, 2023, No. 101; dated April 22, 2024, No. 36; and dated February 24, 2026, No. 33)
2. Decision of the EEC Council dated November 3, 2016, No. 77, «On Approval of the Rules of Good Manufacturing Practice of the Eurasian Economic Union»
3. Decision of the EEC Board dated August 11, 2020, No. 100, «On the Pharmacopoeia of the Eurasian Economic Union»