A single EEC Council decision governs veterinary medicines in the EAEU, from registration to pharmacovigilance
Regulation of medicinal products for human use in the EAEU is split across more than ten separate EEC Council decisions: one for Good Manufacturing Practice (GMP), another for registration, a third for pharmacovigilance, a fourth for labeling, and so on. For veterinary medicinal products, nearly this entire scope of matters is gathered into a single document, EEC Council Decision No. 1, together with its annexes, without the five-module Common Technical Document (CTD) format familiar from ordinary medicines.
This overview opens a series of articles on veterinary products and explains what the unified decision regulates, what remains at the national level, and what the early-2026 reform changed.
How Veterinary Pharmaceuticals Operated Before Common Rules
Before the common rules launched, each EAEU member state regulated the circulation of veterinary medicinal products under its own national legislation. A manufacturer that wanted to sell a product in several member states had to go through registration from scratch in each of them and pay for the review as many times as there were target markets.
In Russia, the main act remains Law of the Russian Federation No. 4979-1 of 14 May 1993, «On Veterinary Medicine» (hereinafter, the Law on Veterinary Medicine). It defines veterinary medicine as a field of scientific knowledge and practical activity aimed at preventing and treating animal diseases, and at protecting people from diseases shared with animals. The circulation procedure for the medicinal products themselves is set out by Federal Law No. 61-FZ of 12 April 2010, «On the Circulation of Medicines» (hereinafter, FZ-61). It is written as a single text covering both human and veterinary products, so the registration principles overlap considerably.
Some matters are regulated by the Ministry of Agriculture. Order No. 426 of 29 July 2020 set the rules for storing veterinary medicinal products, with separate temperature regimes for different drug groups. Order No. 779 of 18 November 2021 defined the procedure for compiling a registration dossier for a feed additive. Order No. 862 of 13 December 2022 established the rules for issuing veterinary accompanying documents, which ensure traceability of each product batch from the plant to the farm.
The main problem of this period was the incompatibility of national regulatory systems with one another. GMP inspection results from one state were not recognized by the others. The work simply had to be done more carefully: every country collected and checked the same documents all over again.
One Decision Instead of National Systems
On 21 January 2022, the EEC Council adopted Decision No. 1, «On the Rules for Regulating the Circulation of Veterinary Medicinal Products in the Customs Territory of the Eurasian Economic Union» (hereinafter, Decision No. 1). The decision was published on 11 February 2022 and entered into force on 13 March 2022. Paragraph 1, which enacts the Rules themselves, was given a separate deadline: 24 months from the decision’s entry into force, meaning the Rules took effect on 13 March 2024. From that date, registration, pharmacovigilance, and manufacturing requirements have been set out in a single document and its annexes.
Decision No. 1 is structured into seven sections: general provisions, the Pharmacopoeia of the Union, manufacturing and storage, circulation of products, registration procedure, information exchange during state oversight, and import requirements.
Specifications and quality control methods for veterinary products are defined by the Pharmacopoeia of the Union, approved by EEC Board Decision No. 100 of 11 August 2020. A direct reference to it was added to the text of Decision No. 1 by EEC Council Decision No. 36 of 22 April 2024; the amendments took effect on 22 June 2024, two years after the main act was adopted. This provision set out what applies if the Pharmacopoeia of the Union lacks a needed monograph: first the pharmacopoeia of the individual member state applies, and if that lacks it too, the regulator relies on the specification document for the particular product.
A different authority is responsible for registration in each member state: in Russia this is Rosselkhoznadzor, in Belarus the Department of Veterinary and Food Surveillance of the Ministry of Agriculture and Food, and in Kazakhstan the Committee for Veterinary Control and Supervision of the Ministry of Agriculture. The applicant submits documents in Russian to the competent authority of one country, and that authority becomes the reference registration authority for that particular application. The standard review timeframe is 235 working days. It is shortened to 155 working days if the product contains active substances or falls under specific categories listed in Annex 8 to Decision No. 1.
The registration dossier follows the structure set out in Annex 11 to Decision No. 1, with separate requirements for study scope under Annex 19 and for submission format under Annex 20.
A full registration procedure is not required separately for every market in the Union. Section V of Decision No. 1 sets out a procedure for recognizing an existing registration in a member state where the product does not yet have the right to circulate, including states that have newly joined the Union. The applicant approaches the same reference registration authority that conducted the initial registration; that authority assigns the application a number and grants the new state’s competent authority access to the dossier. The registration in the new country is treated as starting on the date that authority is granted access to the documents.
Paragraph 27 of the Rules lists the cases where registration is not required at all: pharmacy-compounded products, exhibition samples, materials for non-clinical and clinical studies, products that an individual imports for treating their own animal, reference standards of active substances, herbal medicinal raw materials, active pharmaceutical substances, and products intended solely for export outside the Union.
Manufacturing inspections follow the Rules of Good Manufacturing Practice of the Eurasian Economic Union, approved by EEC Council Decision No. 77 of 3 November 2016. The template for the certificate of manufacturing compliance with these rules is set out in Annex 1 to Decision No. 1, and member states mutually recognize each other’s licenses and certificates. Every manufacturing site is required to have a certified Qualified Person (QP), who is responsible for the quality of batches released for sale and confirms that they comply with the registration dossier.
Labeling of veterinary medicinal products is governed by Decision No. 76, which applies to both human and veterinary products jointly. Since 2024 it has been supplemented by EEC Council Decision No. 118 of 29 November 2024, on labeling veterinary products with identification means. Each member state sets its own date for introducing digital marking: in Russia it has been mandatory since 1 October 2024 for products with a valid registration certificate, and full unit-level tracking of every package starts on 1 September 2026.
The definition of pharmacovigilance, the duties of competent authorities and rights holders, and the procedure for submitting a periodic report on safety and efficacy are written directly into the text of Decision No. 1. An application to confirm registration, together with this report, must be submitted no earlier than 180 working days before the five-year registration term expires and no later than the expiry date itself.
Following the procedure set out in Annex 5 to Decision No. 1, the competent authorities of the member states exchange the results of pharmacovigilance, pharmaceutical inspections, and selective quality control. The pool of adverse-reaction data is built from information that the rights holder and other supply-chain participants submit to the competent authority, which then forwards confirmed cases to the Commission.
Section VII of Decision No. 1 governs the import of products into Union territory. A finished product can only be imported if, at the moment the shipment arrives, it is listed in the Union register of veterinary medicinal products, including during the period when registration is being confirmed. Active pharmaceutical substances require a separate import permit, issued by the competent authority under its own state’s rules.
| Parameter | Before, national rules | Now, EAEU Decision No. 1 |
|---|---|---|
| Registration | Separately in each country | Single procedure via a reference registration authority |
| Review timeframe | Set by each country | 235 working days, 155 for specific groups |
| Recognition of GMP inspections | Did not apply between countries | Mutual recognition of certificates and licenses |
| Dossier structure | By national requirements | Single structure under Annex 11 to Decision No. 1 |
| Pharmacovigilance | Under each country’s rules | Unified standards inside Decision No. 1 |
The 2026 Reform Changes Timelines, Inspections, and the List of Reference Products
EEC Council Decision No. 33 of 24 February 2026 introduced three groups of amendments to Decision No. 1 that matter for the industry.
The transition period has been extended to 31 December 2030. Until this date, manufacturers may keep marketing products registered under national rules, register new products under national law for circulation within a single country, and gradually bring registration dossiers into alignment with Union rules. The conditions differ depending on the registration date: for example, a product registered in Russia in 2021 is subject to one set of deadlines for dossier alignment, while a product registered directly under Decision No. 1 after 13 March 2024 is not subject to the transition period at all. A separate article in this series covers these differences in detail.
Remote pharmaceutical inspection of manufacturing is now legal. A new Clause 325(1) of Decision No. 1 allows a site to be inspected without inspectors traveling to it, through document review, staff interviews, and audio or video communication. The grounds are limited: the threat or occurrence of an emergency, an epidemic, or other circumstances that make it objectively impossible for the whole inspection team to travel. Once those circumstances no longer apply, the next inspection is conducted in person again.
The Commission is building a list of reference veterinary medicinal products, taking into account the recommendations of the Union’s expert council, which operates under Annex 18 to Decision No. 1. This list sets the comparator for generic-drug registration and directly determines which product an applicant must use in bioequivalence studies.
What to Do
Determine the transition-period stage for each product in your portfolio. Check the national registration date and country of circulation. This determines whether the dossier needs to be aligned with Decision No. 1 by 31 December 2030, or whether registration is already proceeding directly under Union rules.
Rebuild the dossier to match the structure of Annex 11 to Decision No. 1. If materials were prepared in the CTD format used for human medicines, do not carry the modular numbering over mechanically; the structures do not match, either by section or by study scope requirements.
Check the GMP certificate status of the manufacturing site. Make sure the document follows the template in Annex 1 to Decision No. 1 and is recognized in the countries you plan to supply. If there is no valid certificate, find out the procedure for substituting a copy of the manufacturing site dossier.
Agree with your partner which country will act as the reference registration authority. This choice affects review timelines, the working language, and the exact list of required documents. To reach new Union markets after the initial registration, a full new review is not required: Section V of Decision No. 1 lets you extend an already-obtained registration through the same reference authority.
Track updates to the list of reference veterinary products. For generics, this list determines the choice of comparator product for bioequivalence studies, and its makeup can change as the expert council issues new recommendations.
For companies entering the EAEU veterinary market for the first time, a single document instead of a dozen separate decisions makes it easier to find your way around. For those who have already worked under national rules, extending the transition period to 2030 gives time to bring the portfolio in order without rushing. It is worth starting this work early, before the deadlines close in.
Regulatory Framework:
1. EEC Council Decision No. 1 of 21 January 2022, «On the Rules for Regulating the Circulation of Veterinary Medicinal Products in the Customs Territory of the Eurasian Economic Union» (as amended on 24 February 2026)
2. EEC Council Decision No. 33 of 24 February 2026, «On Amending Decision No. 1 of the Council of the Eurasian Economic Commission of 21 January 2022»
3. EEC Council Decision No. 77 of 3 November 2016, «On the Approval of the Rules of Good Manufacturing Practice of the Eurasian Economic Union»
4. EEC Council Decision No. 76 of 3 November 2016, «On the Approval of Requirements for the Labeling of Medicinal Products for Human Use and Veterinary Medicinal Products»
5. EEC Council Decision No. 118 of 29 November 2024, «On the Labeling of Veterinary Medicinal Products by Means of Identification»
6. Law of the Russian Federation No. 4979-1 of 14 May 1993, «On Veterinary Medicine»
7. Federal Law No. 61-FZ of 12 April 2010, «On the Circulation of Medicines»
8. Order of the Ministry of Agriculture of Russia No. 426 of 29 July 2020, «On the Approval of Rules for the Storage of Medicinal Products for Veterinary Use»
9. Order of the Ministry of Agriculture of Russia No. 779 of 18 November 2021, «On the Approval of the Procedure for Compiling a Registration Dossier for a Feed Additive and Requirements for the Documents It Contains»
10. Order of the Ministry of Agriculture of Russia No. 862 of 13 December 2022, «On the Approval of Veterinary Rules for Organizing the Preparation of Veterinary Accompanying Documents»