EAEU Drug Registration Transition Ended. How the 3+2 Mechanism Protects Your Portfolio in 2026
By December 2025, the pharmaceutical industry was approaching the deadline with understandable tension. Thousands of medicinal products across the Eurasian Economic Union (EAEU) remained registered under national rules, while the deadline for transitioning to unified requirements was steadily drawing closer. Some companies had submitted their documents well in advance, others were just beginning, and some had not yet started at all. Given this disparity, a full replacement of all national registration certificates by a single date would inevitably have led to shortages in pharmacies.
The Eurasian Economic Commission (EEC) did not wait for this scenario to unfold. Decision of the EEC Council No. 34 dated May 22, 2025, introduced amendments to the Rules for the Registration and Expert Examination of Medicinal Products that the professional community quickly named the «3+2 mechanism.» The Government of the Russian Federation subsequently added a safety net for products that fell outside the mechanism. The Ministry of Health of the Russian Federation clarified the practical application of the entire system in Letter No. 25-6/894 dated January 29, 2026.
Below we cover how each of these norms operates, which products are covered by each, and what to do right now.
The Origin of the December 31, 2025 Deadline
When the EEC Council adopted Decision No. 78 in November 2016, the industry received nine years to transition to unified standards. The rationale was sound: instead of five separate registrations in five countries, a single Registration Certificate (RC) valid across the entire Union territory would be issued.
Since then, new medicinal products have been registered under EAEU rules. For older products with national RCs, a «bringing into compliance» procedure was established — essentially a re-registration under the unified procedure with a redesigned dossier in the Common Technical Document (CTD) format. The deadline for submitting applications was set for December 31, 2025.
On paper, the logic was clear. In practice, the workload proved significant. The procedure requires a full reformatting of the registration dossier into CTD modules, updating quality data, and often conducting additional stability or bioequivalence studies. After expert examination in the Reference State, a separate mutual recognition procedure begins in each country of circulation. For a portfolio of several dozen products, this represents years of work.
In 2022–2023, the regulatory capacities of the Member States also came under additional strain. Some companies shifted their priorities; others faced supply chain disruptions. As a result, by mid-2025, according to Kazakhstan’s National Centre for Expertise, applications had been submitted for only 62% of products in circulation in that country. More than one-third of the market was approaching the deadline without having filed.
Three Scenarios After December 31, 2025
Here are the three scenarios a product may fall into after the deadline.
Application Submitted — the 3+2 Mechanism
This is the primary protective mechanism, introduced by EEC Council Decision No. 34 dated May 22, 2025 (entered into force June 21, 2025; certain provisions apply retroactively from January 1, 2024).
The single condition: the application for bringing the registration dossier into compliance must be submitted to the authorised body or expert organisation of the Reference State before December 31, 2025.
For those who filed on time, the national RC remains valid during the procedure, but for no more than 3 years from the date of filing in the Reference State. After the expert examination there is completed, mutual recognition in the Recognizing States begins, with an additional period of no more than 2 years allocated for this. The application in the Recognizing States must be filed within three years of the original filing in the Reference State.
This is the 3+2 formula: the maximum cumulative protection reaches five years from the date of the initial filing.
For products that fully completed the compliance procedure in the Reference State before December 31, 2025, a separate extension applies: national RCs in the Recognizing States are extended by 2 years starting from December 31, 2025 — specifically, until December 31, 2027.
According to the Ministry of Health of the Russian Federation (Letter No. 25-6/894), the status of the national RC in the State Register of Medicinal Products (SRMP) remains «Active» during the procedure. Once the compliance procedure is completed, the status changes to «EAEU», the manufacturer receives an additional 180 calendar days to release products under the old RC, and the product may continue to circulate until its shelf life expires.
Article 180 of the Registration Rules adds a practical detail that is easy to overlook: throughout the entire procedure, simultaneous import and sale of the product in two packaging variants is permitted — under the national dossier and under the dossier brought into compliance with Union requirements. The manufacturer may begin supplying EAEU-labelled packaging without waiting for existing national-labelled stock to be exhausted. There is no need to synchronise the packaging change with the date the procedure ends.
Application Not Submitted, but the Product Was Actively Circulated — Government Decree No. 353
This is a norm of Russian law only and does not extend to other EAEU Member States.
Government Decree No. 2202 dated December 29, 2025, amended Government Decree No. 353 «On Specific Features of Licensing Activities.» The new paragraph 6(2) extends the validity of national RCs until January 1, 2027, for products that simultaneously meet two criteria:
- no application for bringing the dossier into compliance was submitted by December 31, 2025, and
- as of December 1, 2025, the product had been introduced into civil circulation for at least three consecutive calendar years.
For such products, production, import, and full circulation are permitted until January 1, 2027. National RCs are not reissued under this provision.
It is important to understand: this year is not an indefinite extension. Companies must use it to make a deliberate decision — either initiate a new registration under EAEU rules (no longer eligible for the 3+2 mechanism) or plan an orderly market withdrawal.
No Application Filed, and Less Than Three Years of Circulation
For products that fall under neither the 3+2 mechanism nor Government Decree No. 353, the status in the State Register of Medicinal Products changed to «Expired» as of January 1, 2026.
Circulation of such products in Russia is permitted only for batches produced before the RC expiry and placed into civil circulation before that same date. They may be sold until the shelf life of individual batches expires. No new batches may be produced, imported, or released.
Comparison of Scenarios
| Situation | Production in Russia | Circulation in Russia | SRMP Status | Valid Until |
|---|---|---|---|---|
| Application filed, procedure ongoing | Permitted | Permitted | «Active» | Up to 3 years from filing in Reference State (+2 years in Recognizing States) |
| Procedure completed (at any point) | 180 days from completion | Until shelf life expires | «EAEU» | Based on shelf life |
| Compliance completed in Reference State before 31.12.2025, Recognizing States not yet finished | Permitted | Permitted | «Active» | Until 31.12.2027 in Recognizing States |
| Not filed, 3+ years in circulation (GD No. 353 para. 6(2)) | Permitted | Permitted | National | Until 01.01.2027 |
| Not filed, less than 3 years in circulation | Prohibited | Imported stock only | «Expired» | Until shelf life of existing batches |
Reference State — the EAEU Member State in which the compliance application is filed first; Recognizing States — the remaining Member States where the product seeks recognition; SRMP — State Register of Medicinal Products
Parallel Procedures and Change Management
Beyond the timelines, Decision No. 34 removed another constraint that had been slowing work on active portfolios.
Previously, it was not permitted to combine the compliance procedure with the introduction of changes to the registration dossier. The full alignment procedure had to be completed before any updates could be initiated. For products with actively evolving dossiers, this meant a pause in the product life cycle lasting several years.
That restriction has been lifted. Changes to the registration dossier may now be introduced before the compliance procedure begins or at any point during the procedure, including the mutual recognition stage in the Member States. After recognition is completed, the approved changes are submitted to the Recognizing States with confirmation from the Reference State.
This removes the need to delay transitions to new manufacturing sites, changes of active pharmaceutical ingredient suppliers, or extensions of indications until the end of the transitional period.
When Recognizing States Were Added by a Separate Application
In September 2025, the EEC Council adopted Decision No. 77 (dated September 12, 2025), extending the 3+2 logic to an additional scenario. It covers manufacturers who filed, before December 31, 2025, an application to amend their dossier to add Recognizing States that had not previously been listed.
If a company had already registered a product in two or three EAEU countries and wished to add another, but managed to file the documents before the deadline, national RCs in that new country are extended for the duration of the procedure, but no later than December 31, 2027.
What to Do
Start by identifying which of the three groups each product in the portfolio falls into. All subsequent decisions flow from that.
- Audit the portfolio and assign statuses. Divide products into three groups: application filed (green), not filed but 3+ years in circulation (yellow), not filed and not eligible for Government Decree No. 353 (red). This is the foundation.
- Green group: monitor expert examination deadlines. Record the date of filing in the Reference State, the current examination status, and the planned date for filing in the Recognizing States. The three-year clock runs from the filing date. If two years are approaching without completed examination, escalate communication with the expert organisation.
- Yellow group: use the year before 01.01.2027. A decision must be made for each product: initiate a new registration under EAEU rules or plan an orderly market withdrawal. Do not leave this decision until late 2026.
- Use parallel procedures. If the dossier needs to be updated during the compliance procedure, do not wait for the main procedure to conclude. Changes can be processed simultaneously.
- Verify the Recognizing States for each product. For products that have completed compliance in the Reference State, confirm that the application in the Recognizing States was filed within three years of the original filing date. Missing this deadline means losing the right to the two-year extension in the Recognizing States.
Most products with submitted applications will complete the transition by the end of 2027–2028. The mechanism is finite, and no further extension of the transitional period is expected. The time that has been secured must be used to genuinely complete the transition.
Regulatory Basis:
- Decision of the EEC Council dated 03.11.2016 No. 78 «On the Rules for Registration and Expert Examination of Medicinal Products for Medical Use» (as amended 22.05.2025)
- Decision of the EEC Council dated 22.05.2025 No. 34 «On Amendments to EEC Council Decision dated November 3, 2016 No. 78» (entered into force 21.06.2025)
- Decision of the EEC Council dated 12.09.2025 No. 77 «On Amendments to EEC Council Decision dated November 3, 2016 No. 78»
- Decree of the Government of the Russian Federation dated 12.03.2022 No. 353 «On Specific Features of Licensing Activities in the Russian Federation»
- Decree of the Government of the Russian Federation dated 29.12.2025 No. 2202 «On Amendments to Certain Acts of the Government of the Russian Federation»
- Letter of the Ministry of Health of the Russian Federation dated 29.01.2026 No. 25-6/894