The EAEU alignment deadline expired in December 2025.
Here is what marketing authorization holders need to know.
31 December 2025 marked the expiration of the deadline regulatory affairs professionals had debated for three consecutive years. All national marketing authorizations not brought into alignment with the requirements of the Eurasian Economic Union (EAEU) were slated to lose their validity on that exact date. The market anticipated a wave of product withdrawals and retail pharmacy shortages.
None of this materialized because, one month prior to the deadline, the Council of the Eurasian Economic Commission (EEC) enacted amendments that fundamentally altered the logic of the transitional period. EEC Council Decision No. 34 of 22 May 2025 introduced an extension for companies that managed to submit applications on time, leaving unprotected those who failed to do so. The distinction between these two groups currently dictates the fate of hundreds of registration dossiers.
What Decision No. 78 Regulates and Why It Serves as the Industry’s Core Regulation
EEC Council Decision No. 78 of 3 November 2016, «On the Rules for Registration and Examination of Medicinal Products for Human Use,» establishes the procedures for registration, confirmation of registration, dossier variations, and the expert evaluation of medicinal products across the Union territory. Entering into force on 6 May 2017, the document has since undergone more than ten amendments, including major revisions: No. 114 of 20 October 2023; No. 34 of 22 May 2025; No. 77 of 12 September 2025; and No. 93 of 26 November 2025.
For a regulatory professional, the current consolidated version takes precedence; the historical lineage of individual amendments is secondary. The rules have changed with such frequency that relying on an obsolete text can result in a serious error within a dossier.
The timeline for evaluating a medicinal product in the reference member state under the mutual recognition procedure stood at 210 calendar days in the 2016 edition. Following the amendments under EEC Decision No. 36 of 17 March 2022, this timeframe was reduced to 140 working days. Both numbers still circulate in reference materials, but only the latter reflects the effective legislation.
The Previous Structure of the Transitional Period and Its Inherent Risks
Prior to the 2025 amendments, Clause 2 of Decision No. 78 mandated that marketing authorization holders align their registration dossiers with Union rules before 31 December 2025. An authorization issued under the national legislation of an individual member state remained valid strictly until that date, irrespective of the active processing stage of the alignment procedure.
This framework generated a legal void. Dossier evaluation requires months, sometimes years, if a manufacturing site inspection or stability data clarification is warranted. A company could submit an application in 2024, undergo the evaluation in full compliance, and still forfeit the right to commercialize the product on 1 January 2026, simply because the competent authority failed to finalize the procedure in time.
The Extension Depends on the Application Filing Date in the Reference Member State
EEC Council Decision No. 34 of 22 May 2025 entered into force on 21 June 2025 and added a new Subclause «e» to Clause 2 of Decision No. 78. It splits marketing authorization holders into two distinct groups based on a single condition: whether an application for alignment with Union requirements was submitted to the reference member state prior to 31 December 2025.
Table 1. Marketing authorization status based on the submission date of the alignment application.
| Parameter | Application Submitted by 31.12.2025 | Application Not Submitted |
|---|---|---|
| Authorization status in the reference state | Extended for the duration of the procedure, up to a maximum of 3 years from the filing date | Invalid as of 31.12.2025 |
| Status in concerned member states | Up to an additional 2 years; the application must be filed before the expiration of the 3-year period in the reference state | No extension |
| Status of released batches | Commercialization permitted until the expiration of the shelf life | Commercialization is governed by the national legislation of the specific member state |
The wording «not more than 3 years» indicates that there is no automatic extension for the full three-year term. The marketing authorization remains valid strictly for the duration of the procedure, capped at the statutory three-year ceiling. If the assessment concludes in eight months, the extension remains valid for eight months.
A separate provision governs scenarios where the alignment procedure in the reference member state was completed before the end of 2025, while recognition in other Union states is still ongoing. For these dossiers, concerned member states receive an extension of up to 2 years starting 31 December 2025, irrespective of the initial application date in the reference state.
Actual Timelines for Primary Procedures
The figure «100 days» frequently appears in reference materials addressing alignment with Union requirements. In practice, Clause 173 of the Rules allocates no more than 70 working days for this procedure from the date of application submission in the reference member state. The Rules reserve the 100-working-day timeframe for an entirely different pathway: the accelerated assessment for orphan drugs, pediatric formulations, and medicinal products of exceptional public health importance.
Table 2. Assessment timelines for primary registration procedures.
| Procedure | Reference Member State | Concerned Member States |
|---|---|---|
| Mutual Recognition Procedure | 140 working days | Up to 60 working days after receiving dossier access |
| Decentralized Procedure | 140 working days | Up to 50 working days |
| Alignment with Union Requirements | Up to 70 working days | Governed by mutual recognition rules |
| Accelerated Assessment (Orphan/Pediatric) | Up to 100 working days | Not applicable |
These timelines exclude the clock-stop periods granted to the applicant to respond to requests from the expert evaluation body. This response window can reach up to 180 working days, potentially extending the total timeline by a year or more beyond the nominal statutory values.
Actual Composition of Module 1 for GMP and Pharmacovigilance
Clause 1.6 of Annex No. 1 to Decision No. 78 governs manufacturing documentation: a copy or official details of the Good Manufacturing Practice (GMP) certificate, the manufacturing license, the site inspection report for the preceding 3 years along with a Corrective and Preventive Action (CAPA) plan, a Qualified Person (QP) declaration, and manufacturing site diagrams. Clause 1.10 governs pharmacovigilance: a summary of the holder’s pharmacovigilance system (or a full Pharmacovigilance System Master File for initial submissions), confirmation of the appointment of a Qualified Person for Pharmacovigilance (QPPV), and a Risk Management Plan (RMP).
For the alignment procedure, this list is truncated. Clause 11.1 of Annex No. 1 explicitly sets out the mandatory components from this set: 1.6.1, 1.6.2, 1.6.7, 1.6.9, and 1.6.11 for manufacturing, and 1.10, 1.10.1, and 1.10.2 for pharmacovigilance. The Risk Management Plan (1.10.3) is not included in this mandatory baseline and is requested separately only when necessary.
Classification of Post-Authorization Variations
Annex No. 19 categorizes variations to the marketing dossier into four types: minor Type IA, minor Type IA with an immediate-notification requirement (the EAEU designation «IAНУ,» requiring notification within 20 working days following implementation), minor Type IB, and major Type II. For Type IA variations, the application may be submitted within 365 calendar days post-implementation under the «do-and-tell» principle. Type IB and Type II variations require prior approval through expert evaluation before taking effect.
For a medicinal product authorized across several Union member states, the assessment of a Type IB variation in the reference state takes up to 30 working days, while a Type II variation requires up to 60 working days. Both intervals may be extended by the expert evaluation body when grouping multiple variation types within a single submission: up to 60 working days for groups excluding Type II variations, and up to 80 working days for groups containing them.
Supplementary Safeguard for Products Authorized Exclusively in Russia
Beyond the Union-level framework under Decision No. 34, holders of Russian national marketing authorizations can leverage a domestic safeguard. Resolution of the Government of the Russian Federation No. 353 of 12 March 2022, «On the Specifics of Permissive Activities in the Russian Federation,» in its effective wording, permits the circulation of medicinal products for which an alignment application was not submitted by 31 December 2025, until 1 January 2027, provided that the product was in continuous commercial distribution for at least the three preceding consecutive calendar years as of 1 December 2025.
This mechanism neither replaces the procedure for alignment with Union requirements nor extends the marketing authorization itself. It strictly permits the physical circulation within Russian territory of commercial batches already present on the market throughout the transitional period. Resolution No. 353 is subject to periodic updates, so the current consolidated version should be verified prior to making regulatory determinations for any given product.
Action Plan
Verify the status of every marketing authorization in your portfolio. Segment products into three categories: alignment completed, alignment in progress, or no application filed.
For completed procedures in the reference member state, clarify the status in the concerned member states. The two-year window to submit applications to these countries is calculated from 31 December 2025 and runs continuously regardless of subsequent applicant actions.
For ongoing procedures, document the precise submission date in the reference member state. This date determines both the three-year extension ceiling and the definitive deadline for filings in concerned member states.
Work exclusively with the latest consolidated version of Decision No. 78. Prior to compiling a new dossier, verify assessment timelines and Module 1 document requirements against the active text: amendments from 2022 to 2025 altered several procedural timeframes.
For products holding only a Russian national authorization with no application filed, verify eligibility under Resolution No. 353. The criterion requires uninterrupted market presence for at least three consecutive calendar years as of 1 December 2025.
For products ineligible for transitional relief, consult legal counsel regarding pathways for commercializing already manufactured batches in accordance with the national legislation of the respective Union member state.
Decision No. 78 remains the foundational regulatory document for any regulatory affairs specialist in the EAEU. The 2016 original and the 2026 legal framework represent two fundamentally distinct sets of rules under the same title. A company that aligns with the current legal text and tracks submission dates accurately navigates the transitional period without disruption. A company relying on outdated notes and presentations risks forfeiting a marketing authorization over a formality entirely unrelated to product quality.
Regulatory Framework:
1. EEC Council Decision No. 78 of 3 November 2016, «On the Rules for Registration and Examination of Medicinal Products for Human Use,» including Annex No. 1 (Registration Dossier Requirements) and Annex No. 19 (Variation Rules) (consolidated version effective as of 26 December 2025)
2. EEC Council Decision No. 34 of 22 May 2025, «On Amending Decision of the Council of the Eurasian Economic Commission No. 78 of 3 November 2016»
3. EEC Council Decision No. 36 of 17 March 2022, «On Amending Decision of the Council of the Eurasian Economic Commission No. 78 of 3 November 2016»
4. EEC Council Decision No. 18 of 21 February 2025, «On Amending the Requirements for the Package Leaflet and the Summary of Product Characteristics for Medicinal Products for Human Use»
5. Agreement on Common Principles and Rules for the Circulation of Medicines within the Eurasian Economic Union of 23 December 2014
6. Resolution of the Government of the Russian Federation No. 353 of 12 March 2022, «On the Specifics of Permissive Activities in the Russian Federation» (as amended)