EAEU Extends the Veterinary Products Transition Period to 2030. What Changes for Manufacturers
Some regulatory affairs managers are still planning their veterinary registration strategy around a 31 December 2027 deadline. That date circulated at industry conferences for two years running and made its way into dozens of internal roadmaps and presentations. The problem is that on 24 February 2026 the Council of the Eurasian Economic Commission cancelled it.
The transition period under the rules for the circulation of veterinary medicinal products has been extended to 31 December 2030. At the same time, the Commission adjusted how it recognises Good Manufacturing Practice (GMP) certificates for sites located in third countries, and the timeline for closing out inspection findings has been cut by two-thirds. For companies that spent 2024 and 2025 working to a «get it done before 2027» logic, this changes the entire market entry playbook for the union.
How the system worked before 2026
Uniform rules for the circulation of veterinary medicinal products in the EAEU were established by Decision of the EEC Council No. 1 of 21 January 2022 (hereinafter, Decision No. 1). The document introduced supranational requirements covering the full product lifecycle, from preclinical studies through to the destruction of unsold stock, and replaced five separate national registration systems.
The stakes in this transition are high. According to VIC Group, cited at the «Agrarian Policy of Russia» forum, the Russian veterinary medicinal products market reached 121.5 billion rubles in 2024, up 24% year on year. At that pace of growth, the cost of a regulatory misstep, whether losing access to four union markets over a lapsed dossier or re-inspecting a plant that already holds GMP clearance, translates directly into lost revenue for the quarter.
Point 1 of Decision No. 1, which sets out the substance of the registration procedure itself, took effect on 13 March 2024. From that date, registration of new veterinary products under national rules is valid only in the country that issued the registration certificate (hereinafter, RC). There is no longer automatic recognition in the other four member states. A manufacturer that wants to sell a product across all five countries must go through the EAEU procedure, choosing a reference state to run the primary assessment and recognising states to confirm its findings.
For products already on the market before 13 March 2024, Decision No. 1 provided for a transition period. The original deadline for bringing registration dossiers into line with union requirements was set at 31 December 2027, and RCs issued under EAEU rules carried a 5-year term from the date of issue.
The national route was not closed off entirely. A company could continue registering a product under a single country’s legislation if it only intended to sell within that territory. For mid-sized and smaller manufacturers focused on their home market, that option remained cheaper and simpler than the EAEU procedure.
Mutual recognition of GMP certificates remained a separate sticking point. Decision of the EEC Council No. 101 of 27 September 2023 made the first amendment to subparagraph «з» of point 2 of Decision No. 1. From that point, national authorities across the union recognised one another’s GMP certificates issued for sites within their own territory. Belarusian manufacturers felt the practical effect first: their national GMP certificates, issued to union standards, became sufficient grounds for putting products into circulation in Russia without an additional Russian inspection.
The gap applied to sites in third countries. If a plant was physically located, say, in India or Serbia, and its GMP certificate had been issued by the authorised body of one EAEU member state, that document carried no automatic recognition in the other four. Each country could demand its own inspection of the same site, doubling the cost and time for importers trying to serve the whole union market.
Decision No. 33 buys three years, with one condition attached
The text of Decision of the EEC Council No. 33 of 24 February 2026 was published on 25 March 2026. It introduced a third package of amendments to Decision No. 1 and took effect on 24 April 2026.
The headline change lifts the hard 2027 deadline. The transition period has been extended by three years, to 31 December 2030. During this period, veterinary products registered under the national legislation of any of the five countries may circulate across the union’s entire customs territory, provided that registration, re-registration, or a dossier change was confirmed for them after 13 March 2024. That condition still stands, and companies should keep it in view when planning their portfolios for the years ahead.
The second amendment concerns GMP certificates for sites in third countries. Where the authorised body of an EAEU member state issued a GMP compliance document for a plant outside the union before Decision No. 1 took effect, the other member states now recognise that document without re-inspecting the same site. For foreign manufacturers supplying several union countries at once, this should cut down on duplicate audits.
The EEC was also instructed to compile, during the transition period, a list of reference veterinary products, with provision for updating it. At the same time, the Commission clarified the formats for pharmaceutical inspections, on-site and remote, and cut the timeline for corrective and preventive actions (CAPA) following an inspection to 60 days, with a pre-agreed action plan now mandatory. Remote inspections remain a crisis-response measure; the on-site format is still the default.
The changes already have administrative backing at the national level. Russian Government Resolution No. 295 of 19 March 2026 gave Rosselkhoznadzor, Russia’s veterinary and phytosanitary oversight service, the authority to issue EAEU GMP certificates to veterinary product manufacturers, closing part of the organisational gap that had been slowing down the unified procedures through 2024 and 2025.
What the extended transition period means for pharmacovigilance
Mutual recognition of registration is directly tied to the post-market quality control system. Federal Law No. 61-FZ of 12 April 2010 requires any organisation importing a veterinary product into Russia to submit a notification for each batch placed into circulation, along with confirmation that the production site meets GMP requirements. As long as a foreign plant’s GMP certificate was not automatically recognised, the RC holder had to maintain parallel documentation across several national pharmacovigilance systems, each with its own reporting deadlines and adverse-event notification forms.
Extending mutual GMP recognition to third-country sites only partially reduces that administrative load. The obligation to file periodic safety and efficacy reports in every country where the product circulates remains in place: Decision No. 33 amended the procedure for confirming manufacturing status, not the post-registration monitoring system. RC holders operating in several union countries at once still need to track pharmacovigilance reporting deadlines against each jurisdiction’s national legislation, not just against EAEU rules.
Cutting the CAPA timeline to 60 days applies specifically to manufacturing non-conformities identified during an inspection, and formally has nothing to do with resolving quality issues in batches already on the market. In practice, though, the two processes intersect: if an inspection uncovers a systemic problem at a site, this can trigger an unscheduled risk review of batches already released and, depending on the scale of the non-conformity, a recall from one or more union markets.
That risk is reinforced by the union’s mechanism for sharing information on substandard products. Decisions of the EEC Board No. 70 and No. 71 of 30 May 2023 established a unified database on adverse reactions in animals and a separate register for substandard, falsified, and counterfeit veterinary products. Formally, this is a consumer-protection tool. For an RC holder with recognition across all five member states, it also means that a quality problem with a batch, flagged in one country, becomes visible to regulators in the other four almost immediately, without a separate investigation in each jurisdiction.
How the recognition procedure works, and where the unified registry stands
The mutual recognition mechanism under Decision No. 1 splits roles between member states. The manufacturer selects one country as the reference state, whose authorised body carries out the full dossier assessment, covering quality, efficacy, and safety. The remaining countries where the applicant wants to sell the product act as recognising states, confirming the assessment’s findings without re-running the substantive review.
The scheme removes the need for a fivefold dossier assessment. It does not, however, amount to a full waiver of national oversight. A recognising state retains the right to refuse market entry on its territory if a ban on the specific active substance is in force there, or if national restrictions apply to its use in food-producing animals. A single registration, in other words, does not automatically mean a single product range across all five countries.
The information infrastructure supporting this scheme consists of a set of separate registries and databases, each serving its own process, rather than a single shared portal. Decision of the EEC Board No. 104 of 17 August 2021 launched the unified registry of veterinary medicinal product manufacturers whose production is recognised as GMP-compliant. Decisions of the EEC Board No. 70 and No. 71 of 30 May 2023 added the unified database on adverse reactions in animals and the register of substandard, falsified, and counterfeit veterinary products. The interaction protocol between member states and the EEC for the manufacturers’ registry was updated by Decision of the EEC Board of 10 March 2026, an indication that the system is still being fine-tuned well after its initial launch.
In practical terms, there is still no single window offering a complete picture of any given product. Checking registration status, GMP compliance, and any history of quality violations means going to several national and union-level sources at once.
Then and now
| Parameter | Before 24 April 2026 | After 24 April 2026 |
|---|---|---|
| Deadline for aligning dossiers with EAEU rules | 31 December 2027 | 31 December 2030 |
| GMP recognition for third-country sites | Inspection required by each union country | Mutual recognition without re-inspection |
| CAPA timeline after an inspection | Not uniformly regulated | 60 days, with prior agreement |
| Inspection format | Mostly on-site, without clear regulation | On-site as default, remote as crisis measure |
| List of reference products | Does not exist | Being compiled by the EEC during the transition period |
What to do
Recalculate your portfolio deadlines. Replace the 31 December 2027 date with 31 December 2030 across internal roadmaps and CRO contracts. At the same time, keep the requirement that registration was confirmed, or the dossier amended, after 13 March 2024 as a condition for retaining recognition across the union.
Check the GMP certificate status for overseas sites. If production is based in a third country, confirm which EAEU member state issued the GMP certificate and its validity date. Meeting the requirements of Decision No. 33 opens up recognition by all five union countries without a repeat inspection.
Prepare for the faster CAPA cycle. Review your internal procedures for responding to inspectors’ findings. A 60-day window for an agreed corrective action plan means the CAPA draft needs to be ready while the inspection is still under way, before the official report arrives.
Split your portfolio between national and union-wide RCs. For each product, record whether the RC operates under national rules with limited geography or under EAEU rules with recognition across all five countries, and cross-check this against sales plans for 2027–2030.
Track the list of reference products. As soon as the EEC publishes the first version of the list, check it against the active substances in your portfolio, this could simplify registration for new entries.
Check product status across several registries at once. There is still no single window: GMP status, registration, and any history of quality violations need to be checked separately in Rosselkhoznadzor’s national registry, the EEC’s manufacturers’ registry, and, where relevant, the databases of other recognising states.
Extending the transition period eases some of the administrative pressure. It does not, however, change the underlying logic of a single market. Companies that spend all of 2026 adjusting their old strategy to fit the new deadline, instead of moving onto the EAEU procedure itself, risk running the same race again in 2030 with even less time to spare.
Regulatory basis:
1. Federal Law No. 61-FZ of 12.04.2010, «On the Circulation of Medicinal Products»
2. Decision of the EEC Council No. 1 of 21.01.2022, «On the Rules for the Regulation of Circulation of Veterinary Medicinal Products in the Customs Territory of the Eurasian Economic Union»
3. Decision of the EEC Council No. 101 of 27.09.2023, «On Amendments to Decision of the Council of the Eurasian Economic Commission No. 1 of 21 January 2022»
4. Decision of the EEC Council No. 33 of 24.02.2026, «On Amendments to Decision of the Council of the Eurasian Economic Commission No. 1 of 21 January 2022»
4. Decision of the EEC Board No. 104 of 17.08.2021, «On the Technological Documents Governing Information Exchange… for the Registry of Veterinary Medicinal Product Manufacturers»
5. Decision of the EEC Board No. 70 of 30.05.2023, «On the Technological Documents… for the Unified Information Database on Adverse Reactions in Animals»
6. Decision of the EEC Board No. 71 of 30.05.2023, «On the Technological Documents… for the Unified Information Database of Substandard, Falsified, and/or Counterfeit Veterinary Medicinal Products»
7. Russian Government Resolution No. 295 of 19.03.2026, «On Amendments to Certain Acts of the Government of the Russian Federation»