EAEU Decision No. 34 Allows Parallel Dossier Variations. Examination Period Extended to 260 Working Days
In late 2025, regulatory departments at pharmaceutical companies were juggling two concerns at once. The first: getting the application for bringing the registration dossier into compliance with Eurasian Economic Union (EAEU) requirements — commonly known as BIC — submitted before December 31. The second: figuring out what to do with the backlog of dossier variations that could not be filed while the main procedure was still running. Decision of the Council of the Eurasian Economic Commission (EEC) No. 34 dated May 22, 2025, removed the second obstacle — but introduced one change that forces a complete overhaul of project timelines.
The examination period has been extended from 140 to 260 working days. This is not a typo.
Below we unpack what has changed in the rules on parallel submissions, how the BIC mechanism works under the new framework, and what the Good Manufacturing Practice (GMP) update means in practice.
How It Used to Work
The Rules for Marketing Authorization and Expert Examination of Medicinal Products (hereinafter — the Rules), approved by Decision of the EEC Council No. 78 dated November 3, 2016, were built around sequential logic. The examination in the Reference Member State (RMS) had to be completed first, then the mutual recognition procedure was launched in the Concerned Member States (CMS), and only after recognition was finalised could dossier variations be filed.
Clause 66 of the Rules did contain a provision allowing variations «upon completion of the bringing into compliance procedure.» In practice, this meant: close the BIC in the RMS first, then think about variations. Parallel work with CMS states during the variation process was simply not covered.
By 2024–2025, most Marketing Authorization (MA) holders had built up a genuine backlog — manufacturing site updates, changes to the MA holder’s details, packaging revisions. All of it was queuing behind the BIC. Regulatory directors were left choosing between filing variations and slowing down the core procedure, or waiting while the gap between the actual product and the dossier continued to grow.
There was also the persistent pain point of the 140-day examination period. For complex dossiers with multiple rounds of questions and responses, that figure had long been treated as a rough target rather than a reliable guarantee.
What Decision No. 34 Changes
Decision of the EEC Council No. 34 dated May 22, 2025, amends both the Rules (Decision No. 78) and Appendix No. 19 to them. The changes cover four areas.
Parallel Variations During the Recognition Procedure
The revised paragraph 6 of Clause 66 of the Rules now states: the applicant is entitled to initiate a variation procedure in the RMS before the completion of the registration procedure in the CMS. Clause 66(1) adds that variations are permitted during that procedure as well.
This is a significant shift. Clause 172 of the Rules now explicitly permits variations after BIC completion in the RMS — both before and during the mutual recognition procedure in the CMS, including before or after the formal submission to CMS authorities.
One restriction must not be overlooked: filing variations while recognition is active in a CMS requires prior agreement with the competent authority of that state. New Clause 2.5 of Appendix No. 19 to the Rules (as amended by Decision No. 93 of November 26, 2025) establishes a dedicated procedure for such cases.
After recognition is completed in a CMS, the applicant is obliged — not merely entitled — to submit an application for all variations approved in the RMS that were not filed with that CMS before the recognition procedure was launched.
| Parameter | Before Decision No. 34 | After Decision No. 34 |
|---|---|---|
| Variations before launching CMS recognition | Only after BIC finalised in RMS | Permitted once BIC is complete in RMS |
| Variations during active CMS recognition | Not permitted | Permitted by agreement with the CMS authority |
| Post-recognition obligations | Not regulated | Mandatory filing of RMS-approved variations with CMS |
| CMS review period for Type IB/II variations | Standard rules | 20 working days + right of inquiry (90 working days to respond) |
Examination Period Extended from 140 to 260 Working Days
Clause 126 of the Rules has been amended: the figure «140» is replaced with «260.» This is the statutory period within which the competent authority (expert organisation) must complete the examination.
260 working days equals roughly 52 working weeks — just over one calendar year. The EEC has formally acknowledged what the industry has known for years: examination of complex dossiers routinely takes longer than 140 days. The norm has been brought into line with actual practice.
For planning purposes: if a BIC application was filed in early 2026, the decision from the RMS should be expected in approximately 13 months, not eight to nine. Add the CMS procedure on top of that. Total timelines to full EAEU registration need to be recalculated across the board.
Transitional Period Under the «3+2» Formula
Sub-paragraph «e» of Clause 2 of Decision No. 78 (as amended by Decisions No. 34 and No. 77) establishes the rules for extending national Marketing Authorizations. Two types of applications filed before December 31, 2025, qualify as grounds for extension.
The first is the standard BIC application. The second — introduced by Decision of the EEC Council No. 77 dated September 12, 2025 — is an application for dossier variations linked to the designation of CMS countries where the medicinal product was previously registered. This second route offers a simplified path for applicants who already hold registrations in some EAEU countries and are adding others.
For products where the application was submitted to the RMS before December 31, 2025 but the procedure is not yet complete:
- The MA is extended for the duration of the procedure, but for no more than 3 years from the date of submission to the RMS — in each declared member state
- An additional extension of no more than 2 years applies from the date of submission to the CMS
- The CMS application must be filed no later than the end of the 3-year period from the date of RMS submission
- In the Russian State Register of Medicinal Products (GRLP), such MAs retain the status «Active»
For products where BIC was completed in the RMS before December 31, 2025:
- The MA in the declared CMS countries is extended for the duration of the procedure, but for no more than 2 years from December 31, 2025
- Manufacturing under the national MA is permitted for a further 180 calendar days from the date of BIC completion in the RMS (Letter of the Ministry of Health of the Russian Federation No. 25-6/894 dated January 29, 2026)
- In the GRLP, the status changes to «EAEU», and the validity period is extended by 180 days
| BIC Status | Extension Formula | GRLP Status (Russian Federation) |
|---|---|---|
| Filed, not yet completed in RMS | 3 years from RMS filing + 2 years from CMS filing | «Active» |
| Completed in RMS before Dec 31, 2025 | 2 years from Dec 31, 2025 in CMS + 180 calendar days for manufacturing | «EAEU» |
| Not filed (active circulation 3+ years as of Dec 1, 2025) | Extended to Jan 1, 2027 under Resolution No. 353 (as amended by Resolution No. 2202 of Dec 29, 2025) | «Active» until Jan 1, 2027 |
| Not filed, circulation less than 3 years | MA expiry date | «Expired» from Jan 1, 2026 |
The third row of the table reflects a Russia-specific instrument. Government Resolution No. 2202 dated December 29, 2025, extended to January 1, 2027, the MAs of medicinal products that had been in active civil circulation for at least three consecutive calendar years as of December 1, 2025, but for which no BIC application had been submitted. This is the current edition of Resolution No. 353.
The valid expiry date for Russian-market MAs should always be verified against the current GRLP record.
New Ground for Refusal on GMP Grounds
Clause 159 of the Rules is supplemented with a new basis for refusing registration or bringing into compliance: absence of a valid document confirming that a manufacturing site complies with the EAEU GMP requirements, if more than 3 years have elapsed since the completion of the registration procedure, where that site was included in the inspection plan under Clause 31 of the Rules but has not yet undergone inspection.
The precise construction of the provision matters. The three-year period runs from the completion of the registration procedure, not from the date of application. The ground applies only to sites listed in the inspection plan — that is, sites the regulator has already scheduled for a visit. It is not an automatic requirement applied to all manufacturers.
For companies whose sites appear in such a plan, the position is straightforward: three years is a hard deadline. Once it passes, the regulator has a formal basis to refuse registration or revoke the MA.
How to File Variations During CMS Recognition
Appendix No. 19 to the Rules (as revised by Decision No. 93 of November 26, 2025) is supplemented by Clause 2.5, which sets out the detailed mechanics of parallel variations. The clause distinguishes between two streams.
Insignificant variations (Types IA and IANU). «IANU» denotes a notification-type minor variation requiring immediate notification. After the CMS recognition procedure is complete, the applicant sends that CMS authority the variation application, proof of fee payment (where required under national law), Module 1 documents specific to that state, and a copy of the RMS decision. If the variation does not affect the product’s entry in the unified register, the CMS simply attaches the new version to the electronic dossier. If it does affect the entry, the CMS requests access to the relevant dossier version from the RMS, which must provide it within 5 working days.
Significant variations (Types IB and II). The process follows the same pattern, but the CMS has 20 working days from receipt of the application and documents to reach a decision. Within 15 working days of gaining access to the expert assessment report, the CMS may send a query to the applicant and the RMS. The applicant has 90 working days to respond. Once a positive decision is taken, the CMS updates the unified register within 5 working days.
These are concrete procedural steps with defined timelines — not a general policy statement about «parallelism.»
What to Do Now
1. Recalculate project timelines. 260 working days instead of 140 fundamentally changes the planning horizon. For BIC applications submitted in 2025, the expected RMS decision date shifts by roughly one year from the filing date. Update your project roadmaps accordingly.
2. Check the CMS deadline. If a BIC was submitted to the RMS before December 31, 2025, you have 3 years from that submission date to file in the CMS countries. Missing this window means losing the right to extend the national MA in the relevant country.
3. Consolidate accumulated variations into packages. Variations can now be filed in parallel with the recognition procedure. Review your backlog: which variations are ready for RMS submission, which will require CMS coordination, and which must wait until recognition is finalised. Build a single consolidated package.
4. Confirm the inspection plan status of your manufacturing sites. If your sites are listed in the inspection plan under Clause 31 of the Rules, you have 3 years from the completion of the registration procedure. Establish the precise start date for each site.
5. Study Clause 2.5 of Appendix No. 19. Filing variations during active CMS recognition requires advance agreement with the CMS competent authority. This is a negotiated procedure, not a unilateral right.
Decision No. 34 has meaningfully eased the path for companies that began the BIC process in time. Parallel variations are now permitted under clear rules, with defined timelines for each variation type. The «3+2» extension formula provides a predictable window for managing national MAs through the transition. But 260 working days instead of 140 is a clear signal: the regulator has stated realistic timelines. Build them into your plans from the start.
Regulatory framework:
1. Decision of the EEC Council No. 78 dated November 3, 2016, «On the Rules for Marketing Authorization and Expert Examination of Medicinal Products» (as amended by Decisions No. 34, No. 77, No. 93)
2. Decision of the EEC Council No. 34 dated May 22, 2025 (parallel variations, 260-day examination period, transitional period, GMP)
3. Decision of the EEC Council No. 77 dated September 12, 2025 (extended grounds for MA extension)
4. Decision of the EEC Council No. 93 dated November 26, 2025 (revised Appendix No. 19, confidentiality of dossier data)
5. Resolution of the Government of the Russian Federation No. 2202 dated December 29, 2025, amending Resolution No. 353 (MA extension to January 1, 2027)
6. Letter of the Ministry of Health of the Russian Federation No. 25-6/894 dated January 29, 2026 (clarification on the application of the transitional period)