Drug Registration in the EAEU — the «3+2» Mechanism Gives Manufacturers Up to Three Years to Align
December 31, 2025, was supposed to mark the end of the EAEU’s nine-year transition period. Thousands of medicines registered under national rules risked losing their legal basis for circulation on the Union market. Manufacturers had known about this deadline for years, but awareness alone was not enough: assembling a dossier in Common Technical Document (CTD) format means five structured modules, and for products with a long history on the market, it often involved months of work reconstructing data that had never been organized in that format before.
The EEC Council adopted Decision No. 34 dated 22.05.2025, adding a new set of provisions to the Rules for Registration and Examination of Medicinal Products (EEC Council Decision No. 78 dated 03.11.2016, hereinafter the Rules) on the procedure for bringing dossiers into alignment with Union requirements. The market now has a workable tool for completing pending procedures through legitimate channels. Here is how it works.
Why the Transition Stalled
The EAEU single pharmaceutical space has existed since 2016. The logic was straightforward: all products in circulation would gradually transition to the unified rules of the Union, and national marketing authorizations (MAs) would eventually lose their validity. December 31, 2025, was the agreed endpoint.
In practice, the procedure proved far more demanding than originally anticipated. The CTD format requires a structured dossier with five modules, each of which must precisely meet the requirements of the Rules. For products with a long history of circulation, this meant going back through stability data, quality control methods, and non-clinical and clinical materials. Expert organizations across the member states could not work through the volume of submitted applications in time.
By 2025, a substantial backlog of uncompleted procedures had built up: applications submitted, dossiers under review or being revised, but final EAEU MAs not yet issued. Allowing these products to automatically exit the market on January 1, 2026, would have created shortages without any grounds in safety or quality. Decision No. 34 addresses this directly.
What Changed in the Registration Rules
The amendments to the Rules introduce several interconnected mechanisms.
The «3+2» Mechanism — How Timelines Are Calculated
The core change is a system for extending the validity of national MAs during the examination period (subparagraph «e», paragraph 2 of the Rules, as amended). The extension period depends on the state’s role in the mutual recognition procedure: the reference member state (RMS) conducts the primary examination, and the concerned member state (CMS) subsequently recognizes its results.
| Situation | Condition | Extension Period |
|---|---|---|
| Application submitted to RMS, procedure not completed by 31.12.2025 | Submitted by 31.12.2025 | No more than 3 years from the date of submission to RMS |
| Application submitted to CMS | Submitted to CMS before the expiry of the 3-year period from RMS submission | An additional period of no more than 2 years from the date of submission to CMS |
| Procedure completed in RMS before 31.12.2025, ongoing in CMS | Completed in RMS before 31.12.2025 | No more than 2 years starting from 31.12.2025 |
There is a chain here that cannot be broken. The application to the CMS must be submitted before the three-year period from the RMS submission date expires. That three-year window simultaneously limits the timeframe for completing the examination in the RMS and the final deadline for filing in the concerned member states.
The amendments apply to legal relations arising from January 1, 2024. Manufacturers who started the procedure in 2024 and had not completed it by December 2025 are covered by the new provisions.
The Window for Submitting MA Renewal Applications Has Expanded
Decision No. 34 amended paragraph 126 of the Rules, which governs MA renewal (confirmation of registration). A renewal application may now be submitted no earlier than 260 working days before the MA expires; previously, this threshold was 140 working days. Holders of 5-year MAs now have more than a year’s planning horizon to prepare renewal documents. The examination timeline itself has not changed: under paragraph 125 of the Rules, 80 working days are allocated for this in the reference state.
What Happens to Products Already on the Market
Amendments to paragraphs 165 and 186 of the Rules resolved the question of batches already placed on the market. Products released under a national MA during the alignment procedure may continue to be marketed until their shelf life expires. Manufacturers and distributors are not required to withdraw or dispose of compliant products on procedural grounds.
For products from third countries where no alignment application has been submitted, paragraph 164 of the Rules imposes a restriction: marketing after December 31, 2025, is permitted only within the territory of the member state that issued the original national MA, in accordance with that country’s legislation. Cross-border distribution to other Union member states without a submitted application is not permitted.
GMP Certificate for Foreign Manufacturing Sites
One of the most difficult barriers during the transition period has been the requirement to hold a GMP certificate issued under EAEU rules. Many manufacturing sites outside the Union had not undergone EAEU GMP inspections by 2025.
The new paragraph added to clause 159 of the Rules (after the ninth paragraph) sets out the consequence rather than the pathway: the absence of a valid document confirming that a manufacturing site meets EAEU GMP requirements after 3 years from the completion of registration procedures will be grounds for suspension or cancellation of the MA. This applies to sites included in the inspection plan under clause 31 of the Rules that have not yet been inspected.
When submitting a dossier under clause 30 of the Rules, it is not necessary to hold an EAEU GMP certificate at the time of filing — it is sufficient to have the site included in the inspection plan under clause 31. Three years from the completion of registration is the window to undergo that inspection, after which the absence of a certificate becomes grounds for MA cancellation.
Parallel Assessment of Variations
Decision No. 34 adjusted paragraph 172 of the Rules and added a new paragraph 2.5 to Annex No. 19, covering the procedure for submitting variations before the dossier examination in the concerned member states has been completed.
Previously, variations could only be submitted after the main procedure in the concerned member states had closed. Under the amended Rules, the applicant may initiate variations in the RMS before and during the mutual recognition procedure. After the procedure closes in the CMS, the applicant submits an application to the CMS for any variations that were not incorporated into the dossier before the CMS procedure began.
For Type IB (minor variations requiring notification) and Type II (major variations requiring examination) variations in the CMS, a separate procedure applies under subparagraph 2.5.2 of Annex No. 19: the concerned member state reviews the application within no more than 20 working days of receipt. The applicant has no more than 90 working days to respond to any queries raised during this procedure.
Summary of Changes
| Parameter | Before | After |
|---|---|---|
| Validity of national MA with procedure initiated in RMS | Until 31.12.2025 | Up to 3 years from the date of submission to RMS |
| Validity of national MA with procedure initiated in CMS | Until 31.12.2025 | Additionally up to 2 years from the date of submission to CMS |
| Window for MA renewal application (paragraph 126) | No earlier than 140 working days before MA expiry | No earlier than 260 working days before MA expiry |
| Marketing of batches placed under national MA during the procedure | Not explicitly regulated | Permitted until end of shelf life |
| Marketing of third-country products without a submitted application | Across all member states | Only in the state that issued the MA |
| Type IB/II variations during the procedure | After completion of MRP in CMS | Before and during the procedure in CMS (new paragraph 2.5, Annex No. 19) |
Action Plan
Audit your portfolio. Divide your products into three groups: green (EAEU procedure launched, examination under way), yellow (application submitted, dossier incomplete or queries pending), and red (no application filed at all). For the red group, act immediately: without an application to the RMS filed by 31.12.2025, extending the national MA through the «3+2» mechanism is not possible.
Record the RMS submission date and map out your deadlines. All timelines run from this date. The formula: RMS submission date + 3 years = deadline to complete the examination in the RMS and simultaneously the last date to file in the CMS. CMS submission date + 2 years = deadline for the national MA extension in that country.
Check the expiry dates of your existing EAEU MAs. If you hold 5-year MAs expiring within the next year and a half to two years, begin preparing renewal documents now. Under the amended paragraph 126 of the Rules, a renewal application may be submitted no earlier than 260 working days before expiry — plan the start of that process accordingly.Check GMP status for each manufacturing site. If an EAEU GMP certificate is not yet in place, confirm that the site is listed in the inspection plan under clause 31 of the Rules. Calculate the three-year window from the estimated completion date of registration procedures and schedule the inspection with a margin of at least 6 months before that deadline.
Do not wait for the procedure to close before submitting variations. If new stability data have emerged, API suppliers have changed, or quality control methods have been updated, use new paragraph 2.5 of Annex No. 19. Type IB and Type II variations can now be submitted in parallel with the procedure in the concerned member states.
Those who submitted an application to the RMS by December 31, 2025, have two to three years to complete the procedure. Those who did not have lost the right to extend their national MAs. The EAEU registration rules have been amended more than ten times over nine years, with deadlines shifting each time. Decision No. 34 does not appear to leave room for another round.
Regulatory Framework:
1. EEC Council Decision No. 78 dated 03.11.2016 «On the Rules for Registration and Examination of Medicines for Human Use» (as amended by EEC Council Decisions No. 34 dated 22.05.2025, No. 77 dated 12.09.2025, No. 93 dated 26.11.2025)
2. EEC Council Decision No. 34 dated 22.05.2025 «On Amending EEC Council Decision No. 78 dated November 3, 2016»