75 Substances, One Market: How EAEU Veterinary Medicines Regulation Changed After 13 March 2024
Note: One specific fee cited in this article — ₽23,300 for an EAEU GMP certificate — equals approximately $233 at 1 USD ≈ 100 RUB.
Veterinary regulation has long operated in the shadow of human medicine. Registration rules for veterinary medicinal products (VMPs) differed across each EAEU — Eurasian Economic Union — member state, mutual recognition worked only with reservations, and unified quality control was absent.
On 13 March 2024, that changed. EEC — Eurasian Economic Commission — Council Decision No. 1 of 21 January 2022 entered into force, establishing a common market for VMPs across the Union. For the livestock sector, this shift is roughly comparable in scale to the creation of the unified human medicines market in 2017.
January 2026 brought manufacturers additional compliance obligations: residue controls on veterinary products in foodstuffs took full effect on 11 January, and item-level tracking in Chestny ZNAK — Russia’s national product labelling system — launches on 1 March.
How It Worked Before
Before 13 March 2024, VMP registration in EAEU countries followed national legislation in each member state.
Mutual recognition formally existed: a product registered in Armenia could, in principle, be authorized for circulation in Russia. In practice, the mechanism carried serious limitations.
The core problem was an uneven standard of control. Some member states conducted no pre-registration testing, raising doubts about the safety of approved products. Manufacturers exploited the gap — obtaining registration in the country with the lowest requirements, then entering all Union markets. The result was risk for consumers and distorted competition.
Quality requirements diverged as well. No unified GMP — Good Manufacturing Practice — inspection system existed for the veterinary sector. Each country assessed manufacturers under its own rules and issued certificates on different terms. For international companies, that meant repeated inspections with separate costs in every country.
Residue controls on VMPs in animal-derived food products were also unharmonized. Antibiotic limits in meat and milk differed between countries, creating trade barriers within the EAEU and providing grounds for disputes between member states.
What Changed
EEC Council Decision No. 1 of 21 January 2022 established a unified regulatory system for VMPs across the entire Union.
The document entered into force in stages: the main provisions took effect on 13 March 2024, certain norms will remain in phased implementation until 2032. The full transition to registration exclusively under EAEU unified rules is scheduled for 1 January 2028.
Unified Registration Under the Single-Window Principle
A manufacturer or its representative now submits a marketing authorization (MA) application in any EAEU member state of its choosing. That state becomes the Reference Member State and conducts the scientific assessment. Once the MA is granted, the product may circulate across all five Union member states.
Table 1: VMP Registration Procedures Before and After 13 March 2024
| Parameter | Before (pre-13.03.2024) | After (from 13.03.2024) |
|---|---|---|
| Registration procedure | National in each country | Unified under EAEU rules |
| MA recognition | Under separate bilateral agreements | Automatic across all member states |
| Choice of regulator | None | Applicant selects the Reference Member State |
| MA validity | Varied by country | 5 years under unified rules |
If the Reference Member State identifies violations and refuses registration, that information is shared with the regulators of all EAEU countries. Registering the same product in another member state after a refusal then becomes impossible. The rule closes the loophole of «regulatory tourism» to low-scrutiny jurisdictions.
Transition Periods and Deadlines
The rules establish a layered system of transition periods, giving manufacturers time to adapt.
National registration remains available until 31 December 2027, but an MA granted through the national route is valid only in that one country. MAs issued before 13 March 2024, or under the national procedure after that date, are valid until 31 December 2027. By that deadline, registration dossiers must be brought into compliance with EAEU Rules requirements.
MAs granted through the national procedure between 13 March 2024 and 31 December 2027 will remain valid in the issuing country for five years from their date of issue — at most until 31 December 2032.
A simplified procedure applies to 22 groups of straightforward products listed in the annex to Decision No. 1. No dossier alignment is required; these products transfer automatically to the EAEU Unified Veterinary Medicinal Products Register.
Decision No. 1 also contains a list of active substances prohibited for use in food-producing animals. VMPs containing these substances have not been registrable since 13 March 2024, and previously issued authorizations are being withdrawn from circulation.
In late 2025, the EEC published a draft amendment proposing to extend the transition period to 31 December 2030. The document completed its regulatory impact assessment and is now under agreement among member states. If adopted, manufacturers will have additional time for dossier alignment.
New MRL Requirements for Residue Controls
On 11 January 2026, strict residue controls on VMPs in meat and dairy products took full effect across the EAEU. The transition period established by EEC Board Decision No. 13 of 27 February 2024 — 18 months from the entry into force of Decision No. 70 — ended on 10 January 2026.
The EAEU technical regulations now contain a unified list of MRLs — Maximum Residue Levels — for 75 veterinary products and active substances, covering antibiotics, anthelmintics, antiparasitic agents, and other categories. According to EEC Minister Valentin Tataritskyy, establishing MRLs for 75 substances across both unprocessed and processed products has no precedent in international practice.
As an example, the MRL for amoxicillin in meat is set at 0.05 mg/kg. By expert assessments, certain EAEU norms are stricter than the current European standards.
Controls now cover both raw materials (meat, milk) and finished products. Sausages, cheeses, and canned goods are subject to MRL verification. Previously, controls focused primarily on raw meat or raw milk.
Producers releasing animal-derived products into circulation are required to declare information about VMPs applied on the farm during the preceding two months. Accompanying trade documents must state the product name, active substance, date of last application, and withdrawal period (срок каренции). If laboratory testing reveals an MRL exceedance, the batch is subject to destruction.
For VMP manufacturers, this raises the stakes around withdrawal period data. Information on how long after treatment the meat or milk is safe for use becomes one of the deciding factors when livestock farmers select a product.
Companion Animals and Food-Producing Animals
The regulator draws a clear boundary between requirements based on target species.
Table 2: Regulatory Requirements for VMPs by Target Animal Category
| Category | Target animals | Regulatory focus | Dossier specifics |
|---|---|---|---|
| Companion animals | Dogs, cats, small animals, birds | Safety and efficacy for the animal | Emphasis on pharmacokinetics (PK), ease of use |
| Food-producing animals | Cattle, pigs, poultry, aquaculture | Consumer safety | Mandatory withdrawal period data, MRLs in products |
For products used in food-producing animals, additional restrictions apply. The use of chemotherapeutic antibacterial products for disease prevention or productivity enhancement is fully prohibited. Antibiotics may only be used therapeutically, on veterinary prescription — a measure targeting antimicrobial resistance.
Aquaculture sits in its own category. EAEU fish farms are now subject to the same MRL controls as red meat producers. Previously, this sector was the least regulated in terms of residue limits.
GMP Inspections Under EAEU Rules
From 1 March 2026, Rosselkhoznadzor and equivalent agencies in other EAEU member states will conduct pharmaceutical inspections under unified Union rules, issuing GMP certificates as set out in Annex 26 to EEC Council Decision No. 1.
An EAEU GMP certificate becomes a mandatory condition for registering new products and confirming the registration of existing ones. Without it, a manufacturer cannot bring products to market across the Union.
For Russian production sites, confirmation of compliance with EAEU GMP requirements may proceed as part of the licensing process, including through periodic licence renewal reviews.
Foreign plants located outside the EAEU must undergo inspection by the regulator of one of the Union’s member states. Inspections of production facilities in Indonesia, Spain, China, the Netherlands, Turkey, and Estonia are scheduled for 2026. The fee for issuing an EAEU GMP certificate for VMP manufacturers is ₽23,300 (~$233) (Government Decree No. 1681 of 29 October 2025).
A draft amendment to the EAEU Rules provides for remote GMP inspections. If the provision is adopted, manufacturers will be able to undergo assessments without an on-site visit.
Track-and-Trace in Chestny ZNAK
From 1 March 2026, item-level tracking of veterinary medicinal products takes effect in Russia through Chestny ZNAK.
Before this date, market participants could submit aggregated batch-level data to the system. Under the new requirement, electronic delivery notes must include information for each individual marking code.
Mandatory labelling covers vaccines, blood fractions, medicines, and contraceptives for animals. From 1 March 2026, the list also includes insecticides and microorganism cultures (Government Decree No. 1845 of 20 November 2025).
Chestny ZNAK is integrated with FGIS VetIS (Federal State Information System for Veterinary Supervision), specifically with its Horriot component responsible for animal record-keeping. This allows supervisory authorities to detect anomalies. If a farm reports vaccinating 10,000 animals but the labelling system shows only 5,000 doses withdrawn from circulation, that discrepancy becomes grounds for an inspection.
CRPT (the Chestny ZNAK operator) and Rosselkhoznadzor are developing an automatic blocking mechanism for prohibited VMPs at the point of sale. For testing, the agency transferred a dataset of 36,000 unique marking codes across five product groups: cattle vaccines, companion animal vaccines, heart failure drugs, renal failure drugs, and anti-inflammatory agents. The mechanism is expected to go live during 2026.
Registration Timelines
Under Russian national legislation, state registration of a VMP takes up to 120 working days, with the safety and benefit-risk assessment conducted within 110 working days.
Under EAEU rules, the decentralized procedure allows up to 140 working days in the Reference Member State, and up to 50 working days in Recognized States.
MA confirmation — renewal for an indefinite term — takes up to 33 working days under the Russian procedure.
What Manufacturers and Distributors Should Do
1. Conduct a portfolio audit. Divide products into three groups: those registered under the EAEU procedure (green zone), those registered under the national procedure with a valid MA (yellow zone), and products with expiring MAs or no registration in required countries (red zone). Draw up a dossier alignment schedule for the yellow and red zones.
2. Verify the GMP status of production sites. From 1 March 2026, registering new products and confirming existing registrations will not be possible without an EAEU GMP certificate. If a site has not yet undergone a Union-rules inspection, submit an application without delay.
3. Update withdrawal period data. For products used in food-producing animals, accurate withdrawal period data and demonstrated MRL compliance become competitive differentiators. Livestock farms will select products with these parameters in mind.
4. Prepare for item-level tracking. From 1 March 2026, reporting each individual unit to Chestny ZNAK will be mandatory. Verify your IT systems’ readiness, electronic document management integration, and the availability of scanning and code application equipment.
5. Monitor changes to the transition periods. The draft amendment extending deadlines to 31 December 2030 is under review. If adopted, additional adaptation time will become available. Follow publications on the official EAEU portal.
The EAEU veterinary market in 2026 is undergoing changes on the scale of what happened to human medicines several years earlier. Companies that align their operations with the new requirements in time will gain access to the unified market of five states. Those that delay the transition risk losing the right to circulate their products once the transition periods expire.
Sources: Federal Law No. 4979-1 of 14 May 1993 «On Veterinary Medicine» (as amended 26 December 2024); EEC Council Decision No. 1 of 21 January 2022 «On the Rules Governing the Circulation of Veterinary Medicinal Products in the Customs Territory of the EAEU»; EEC Council Decision No. 70 of 23 June 2023 (amendments to technical regulations on MRLs); EEC Board Decision No. 13 of 27 February 2024 (transition period for MRL controls); Federal Law No. 61-FZ of 12 April 2010 «On the Circulation of Medicinal Products» (as amended 31 July 2025); Government Decree No. 1681 of 29 October 2025 (fee for EAEU GMP certificates for VMPs); Government Decree No. 1845 of 20 November 2025 (expansion of the mandatory VMP labelling list).
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