Mutual Recognition Procedure for Medicines in the EAEU — How to Register a Drug in Several Member States at Once
31 December 2025 marked the final deadline for submitting applications to align marketing authorization dossiers with the requirements of the Eurasian Economic Union (hereinafter — the EAEU). Thousands of national marketing authorizations issued under the domestic laws of individual member states had to either transition to Union rules or exit the market.
Applicants who managed to submit on time came out ahead of the rest. Decision of the Council of the Eurasian Economic Commission No. 34 dated 22 May 2025 (hereinafter — Decision No. 34) extended the validity of national marketing authorizations (MA) for the duration of the ongoing assessment: up to three years in the Reference Member State (RMS) and up to two years in each Concerned Member State (CMS). Those who missed the deadline must now register their medicinal products from scratch under the full regulatory framework of the Union, including the Mutual Recognition Procedure (MRP).
How the EAEU Transitioned from National Registrations to a Unified Framework
Prior to 2016, each Union member state registered medicinal products under its own national legislation. A company seeking to market a drug in Russia, Kazakhstan, and Belarus simultaneously had to undergo three independent assessments with divergent dossier requirements, timelines, and documentation packages.
Decision of the Council of the EEC No. 78 dated 3 November 2016, «On the Rules for Registration and Examination of Medicinal Products for Human Use» (hereinafter — the Rules), established a unified procedure across the entire Union with two pathways: the Mutual Recognition Procedure and the Decentralized Procedure. Until 1 July 2021 (and until 31 December 2020 in Russia), applicants could choose whether to register a product under the new Union Rules or via the national route. Those who chose the national route obtained only a temporary postponement: their dossiers still had to be brought into alignment with Union requirements by the final cut-off date of 31 December 2025.
Decision No. 34 left this deadline unchanged. Instead, it added something the Rules had been missing: a mechanism to extend marketing authorizations for the duration of the assessment itself, for applicants who filed on time but whose review was still pending. Without this extension, thousands of products risked losing active marketing status simply because assessment bodies could not keep up with the volume of applications.
Russia has an additional safety net. Decree of the Government of the Russian Federation No. 353 dated 12 March 2022 permits the circulation of medicines until 1 January 2027, even where an alignment application was not submitted before 31 December 2025, provided the product had been on the market for at least three calendar years as of 1 December 2025. This exemption applies only to a narrow category of established legacy products and does not replace the alignment process itself. It should not be relied on as a permanent solution.
Table 1. Impact of Decision No. 34 on Registration Extension Timelines
| Parameter | Prior to Decision No. 34 | Following Decision No. 34 |
|---|---|---|
| Submission deadline for dossier alignment | By 31 December 2025 | Unchanged |
| MA extension during the procedure in the RMS | Not provided | Up to 3 years from the date of application |
| MA extension during the procedure in the CMS | Not provided | Up to 2 years from the date of application in that state |
| Submission of application for MA renewal (re-registration) | Not earlier than 140 working days before MA expiry | Not earlier than 260 working days before MA expiry |
How Mutual Recognition Differs from the Decentralized Procedure
The Rules provide two regulatory mechanisms, and the choice between them shapes the whole market-entry strategy. The Mutual Recognition Procedure applies once a drug already holds a marketing authorization (MA) in one Union member state: the applicant simply asks other member states to recognize the completed assessment report. The Decentralized Procedure applies when the product is not yet registered anywhere in the Union: the RMS and all designated CMSs run their assessments in parallel from the outset, with no pre-existing assessment report to build on.
The Decentralized Procedure runs on its own, shorter timelines than the cumulative duration of the MRP. Registration in the RMS under the decentralized pathway is capped at 140 working days, the same as under MRP, but CMS assessment runs in parallel with the RMS and is capped at 50 working days rather than the sequential 60 plus 40 typical of MRP. For new products a company plans to launch in several markets at once, the decentralized route is almost always faster. For products that already hold an MA in one member state and are expanding into new markets gradually, mutual recognition remains the only available path.
The Operational Workflow of the Mutual Recognition Procedure
The MRP in the EAEU runs in two main stages. First, the applicant obtains a marketing authorization (MA) in the Reference Member State (RMS), the country that conducts the full dossier assessment. The product is then recognized, on the basis of that assessment report, in the Concerned Member States (CMS), the other markets the applicant has chosen to enter.
Registration in the Reference Member State
The applicant selects the RMS independently and submits a full Common Technical Document (CTD) dossier. Registration in the RMS must not take longer than 140 working days from the date of application to MA issuance.
The submission package to the RMS includes the standard application form, proof of payment of the registration and assessment fee, the electronic CTD dossier, and product samples together with reference standards and any specific reagents the testing laboratory needs. Samples are not required where the drug is an orphan, advanced-therapy, radiopharmaceutical, narcotic, or psychotropic product, or where transport or storage conditions for a sample cannot realistically be met; in these cases the quality assessment relies on the manufacturer’s own analytical protocols, including remote review.
A separate requirement applies to the manufacturing site. When filing the application, the applicant must submit a valid EAEU GMP certificate or, failing that, a substitute package: the manufacturer’s national GMP certificate, the report from the most recent inspection of the site in the past three years, a summary of all inspections over that period, and consent to an EAEU GMP inspection. On the basis of these documents, the RMS decides whether an unscheduled inspection is needed within the registration timeline or can be scheduled as part of the routine inspection plan for the first three years after registration.
The RMS competent authority checks the dossier for completeness within 10 working days. If anything is missing, the applicant has up to 90 working days to supply it, and this time does not count toward the overall assessment period. The substantive assessment itself, covering quality, non-clinical, and clinical data, takes up to 105 working days from the completeness check. The applicant has up to 90 working days to respond to each expert query, with extensions possible on justified request, but total response time across all queries must not exceed 180 working days.
Once the assessment is complete, the RMS issues the MA and publishes the product details, including the assessment report, in the unified EAEU medicinal product register.
For products undergoing dossier alignment rather than initial registration, the documentation package is shorter: the applicant files Modules 1–3 and confirms, in a separate «Expert Information Note,» that the updated dossier does not differ in substance from the dossier of the already-registered product. The alignment procedure itself is capped at 70 working days from the date of application, a shorter track than initial MRP registration.
Recognition in Concerned Member States
Once the MA is issued in the RMS, the applicant may seek recognition in several CMSs at the same time, without waiting for one country to finish before filing in the next.
For each CMS filing, the applicant submits a Module 1 adapted to that country’s requirements and, where the country’s legislation requires it, translations of the Summary of Product Characteristics (SmPC) and the Patient Information Leaflet (PIL) into the state language. Packaging artwork is localized the same way, country by country rather than as one combined package. This translation work is usually what stretches the timeline beyond the formal procedural deadlines.
The RMS competent authority must give the CMS assessment body access to the dossier and assessment report within 5 working days of the request. This starts two parallel clocks: registration in the CMS, absent any objections, must be completed within 60 working days of full dossier access, and the assessment itself must not exceed 40 working days from the date access to the report was granted.
If CMS assessors have objections, they must send a query to the applicant and the RMS within 30 working days of getting access to the report. The applicant then has up to 90 working days to respond. If the RMS fails to provide requested documents within 100 working days, the CMS assessment body may issue a finding that the report cannot be recognized and refer the matter to the Expert Committee.
Grounds for Refusal of Recognition
The list of reasons a CMS may refuse to recognize the RMS assessment report is closed and contains five points:
the benefit-risk balance of the product does not appear favorable;
the applicant has not demonstrated the product’s efficacy;
the product’s quality has not been confirmed;
the applicant submitted unreliable data;
an inspection found critical non-compliance with the EAEU’s good pharmaceutical practice requirements.
Minor issues with the translation of the leaflet or the packaging artwork do not fall under these grounds. Authorities resolve those in the normal course of business.
Where one of the five grounds applies, the CMS sends a reasoned opinion to the RMS, the other CMSs involved, the applicant, and the Expert Committee on Medicinal Products at the EEC. The Committee reviews the disagreement within 60 calendar days. If it unanimously finds the data sufficient, the CMS must issue the MA within 15 working days of that decision. While the disagreement is unresolved, states that already reached a positive decision may still issue their MA; at the applicant’s request, issuance can be held back until the dispute with the remaining states is settled.
Expanding Recognition to New Member States Later
An MA holder does not have to name every country of interest in the first application. Registration in the remaining member states, including states that join the Union later, follows the same mutual recognition procedure, based on the current version of the RMS assessment report. The timelines match a standard CMS filing: 60 working days for registration and 40 working days for assessment from the date of access to the report.
Competent Authority-Initiated Registration
Decision of the Council of the EEC No. 117 dated 29 November 2024 added a separate mechanism to the Rules: a member state’s competent authority may register a product already registered in the RMS on its own initiative, without the MA holder’s request. The conditions are strict: no equivalent by international nonproprietary name (INN) and anatomical therapeutic chemical (ATC) code exists in that country, the country has no registration procedure of its own for the product, and the MA holder has given written consent to the use of its dossier. The procedure takes no more than 40 working days from the date consent and the application are received, and the RMS must supply the requested documents within 5 working days.
This can work in the MA holder’s favor where entering a small local market is not a priority: the country gets access to the product without the holder covering the cost of a local registration campaign, while the requirement for written consent keeps the holder in control. A competent authority that registers a product this way gets access to all future dossier changes over the product’s lifecycle and can set its own, shorter validity period than the one issued in the RMS.
Type IA, IB and II variations are a separate matter: they are classified under Annex No. 19 to the Rules, a separate document with its own grounds, deadlines, and eligible initiators, not to be confused with Decision No. 117.
Maintaining a Registration After the MA Is Issued
The first MA issued in the RMS is valid for 5 years. After the first renewal (re-registration), it becomes indefinite. A competent authority may only re-impose a 5-year limit on pharmacovigilance grounds. The renewal application must be filed no earlier than 260 working days before MA expiry, and no later than the expiry date itself. The renewal procedure is capped at 80 working days in the RMS and 50 working days in each CMS.
Changes to an already-registered dossier, from packaging updates to new indications, go through the same competent authority that handled the registration. They are assessed under the Annex No. 19 classification: minor Type IA changes the holder may implement first and report afterward, Type IB changes require prior notice and a waiting period, and major Type II changes require a full assessment with an updated report. The Rules require the MA holder to initiate such changes on its own whenever manufacturing or quality control no longer matches the current state of scientific methods, rather than waiting for the regulator to raise it.
Transfer of the MA is handled separately. Where rights to the product pass to another company, in all countries of registration at once or in only some of them, the new holder files a variation application, documents the legal basis for the transfer, and confirms it is able to coordinate with MA holders in the other member states and to carry out all obligations relating to the product.
How the Equivalent Procedure Works in the European Union
The European counterpart to MRP follows the same logic: a country where the product already holds a national authorization (Reference Member State, RMS) provides the basis for recognition in other countries (Concerned Member States, CMS). The underlying act is Directive 2001/83/EC. The recognition procedure takes 90 days, followed by a 30-day national phase for issuing local authorizations and translating the product information.
An MA holder who has already completed an MRP and wants to add another country does not need to repeat the whole procedure: the EU has a Repeat Use Procedure for reusing an already-approved RMS assessment report with a new CMS. In substance this is a direct equivalent of how the EAEU expands recognition to new member states through the current version of the RMS report, though the formal timelines and documentation differ between the two systems.
The only lawful ground for a CMS to refuse recognition is a potential serious risk to public health (PSRPH). Unresolved disagreements go to the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), and, absent consensus, to the Committee for Medicinal Products for Human Use (CHMP) at the EMA. Classification of post-approval variations in the EU is governed by a separate act, Commission Regulation (EC) No 1234/2008, independent of the registration directive.
Table 2. Key Parameters: EU vs EAEU MRP
| Parameter | EU | EAEU |
|---|---|---|
| Primary act | Directive 2001/83/EC | EEC Council Decision No. 78 |
| Time to recognition in other countries | 90 days + 30-day national phase | Up to 60 working days to register, up to 40 to assess |
| Initial MA validity | 5 years, then indefinite | 5 years, then indefinite |
| Who can initiate registration in a new country | MA holder only | MA holder or the country’s competent authority (Decision No. 117) |
| Act governing variation classification | Regulation (EC) No 1234/2008 | Annex No. 19 to Decision No. 78 |
The practical takeaway for companies already operating in an RMS and planning to expand into new CMSs: EAEU timelines are shorter than the EU’s formal 90 days, but they run on several overlapping clocks, and missing any one of the intermediate deadlines (5 working days for dossier access, 30 working days for a CMS query) throws off the whole schedule more than it looks on paper.
What to Do
Check the status of every dossier in your portfolio. Split products into three groups:
green: the alignment application has been filed and the procedure is on track;
yellow: the application has been filed, the RMS has raised objections, and a response is still pending;
red: no application has been filed at all.
For the red group, registration from 1 January 2026 onward is only possible from scratch, under the full Union Rules, with no reliance on the old national MA.
Treat the date the application was filed with the RMS as your reference point. Both extension periods run from it: up to 3 years in the RMS and up to 2 years in each CMS named, and the CMS application has to go in before the 3-year RMS window runs out. For MAs already in force, mark the date 260 working days before expiry separately — that is the earliest point at which you can file for renewal, and the earlier the procedure starts, the lower the risk of a gap in coverage.
Request CMS dossier access early. The RMS has only 5 working days to grant access once asked. Starting this as soon as the MA is issued in the RMS means both the 60- and the 40-day CMS clocks start without delay.
Build a 90-working-day buffer into the project timeline for responding to expert queries at every stage, in both the RMS and the CMS. This time does not count toward the official procedural deadlines, but it is what actually determines when the product reaches the shelf.
For markets the MA holder has no direct commercial interest in, send a formal written request to the local competent authority asking whether it can register the product on its own initiative under Decision No. 117. This route needs the MA holder’s written consent to use its dossier, and in exchange it takes the administrative burden of running the procedure off the holder’s hands.
The Mutual Recognition Procedure remains the most predictable way to bring a medicine to several EAEU markets at once. The Rules set out clear deadlines for every step. Real delays almost always come down to managing those intermediate deadlines: at the RMS assessment body, among the translators handling the SmPC and the leaflet, and at the MA holder itself. Companies that log the deadline for every stage in one calendar, and do not leave the choice of CMSs to the last moment, get through the whole MRP cycle without losing unplanned months.
Regulatory Framework:
1. Decision of the Council of the EEC dated 3 November 2016 No. 78 «On the Rules for Registration and Examination of Medicinal Products for Human Use» (as amended, consolidated to 26 November 2025)
2. Decision of the Council of the EEC dated 22 May 2025 No. 34 «On Amendments to Decision of the Council of the Eurasian Economic Commission of 3 November 2016 No. 78»
3. Decision of the Council of the EEC dated 29 November 2024 No. 117 «On Amendments to the Rules for Registration and Examination of Medicinal Products for Human Use»
4. Annex No. 19 to the Rules for Registration and Examination of Medicinal Products for Human Use (Classification of Variations)
5. Decree of the Government of the Russian Federation dated 12 March 2022 No. 353
6. Directive 2001/83/EC of the European Parliament and of the Council
7. Commission Regulation (EC) No 1234/2008