Russia’s National Drug Registration Certificates Lost Validity in 2026. Here’s How EAEU Rules Work Now
As of 1 January 2026, a national marketing authorization (MA) for a medicinal product in Russia no longer grants the right to stay on the market on its own if the dossier has not been aligned with the rules of the Eurasian Economic Union (EAEU). For an industry that built its processes around the Ministry of Health of Russia and Federal Law of 12 April 2010 No. 61-FZ, «On the Circulation of Medicines» (hereinafter, 61-FZ), for two decades, this is a shift in the entire frame of reference.
Evaluation of a medicinal product now runs on the logic of a reference state and states of recognition, where one regulator’s decision extends across the whole Union. The dossier is now compiled in the Common Technical Document (CTD) format across five modules. These are different rules from the ones regulatory specialists have known since the 2010s. Companies that treated the dossier alignment procedure as a formality watched their national marketing authorizations lapse one after another in the spring of 2026.
This article opens a series on drug registration under EAEU rules. It sets the coordinates: how the national model worked, what replaced it in substance, and what a company should do if its dossier still runs on the logic of 61-FZ.
The National Model That Ran for Twenty Years
61-FZ structured drug registration as a two-party process: the applicant and the Ministry of Health of Russia. The Ministry commissioned the evaluation to the Federal State Budgetary Institution «Scientific Center for Expert Evaluation of Medicinal Products,» which assessed the quality, safety, and efficacy of the product. The registration decision was valid only within the Russian Federation. A company that wanted to sell a drug in Kazakhstan or Belarus went through a separate national procedure in each country from scratch, with its own timelines, dossier requirements, and panel of assessors.
Appeals against refusals, responses to assessor queries, and dossier variations all sat within one jurisdiction and one set of rules. A regulatory affairs manager dealt with a single regulator and a single point of accountability. This model was straightforward. It also produced duplication: the same active substance and the same manufacturing process were checked by five different regulators in five member states against five different sets of criteria.
Dossiers were compiled under national requirements that allowed submission as paper volumes or plain PDF scans. A marketing authorization was typically issued for five years, followed by a renewal that made it indefinite. Compliance with Good Manufacturing Practice (GMP) was verified under national rules approved by Order of the Ministry of Industry and Trade of Russia of 14 June 2013 No. 916 (hereinafter, Order No. 916). Inspections were run by the Ministry of Industry and Trade, and the certificate was valid only inside Russia.
This model was linear and predictable. It scaled poorly to a five-country union market: every country assessed the same dossier from zero, and manufacturers spent resources on parallel procedures that often diverged in their requirements. The Treaty on the EAEU of 29 May 2014 and the Agreement on Common Principles and Rules for the Circulation of Medicines within the EAEU of 23 December 2014 laid the legal groundwork for moving away from that logic toward mutual recognition.
What Replaced 61-FZ in Substance
The unified Rules for Registration and Examination of Medicinal Products for Human Use were approved by Decision of the Council of the Eurasian Economic Commission (EEC) of 3 November 2016 No. 78 (hereinafter, Decision No. 78). Unlike the national procedure, Decision No. 78 introduces a reference state and states of recognition model.
The manufacturer chooses the reference state itself; that state’s regulator carries out the core evaluation of quality, safety, and efficacy. The other Union states where the product will be sold act as states of recognition: they review the reference state’s assessment report and either accept its conclusions or raise queries. This is the main practical difference for a regulatory affairs manager: one evaluation cycle instead of several parallel national procedures.
Choosing the reference state calls for a strategic calculation, since it drives the pace of the whole procedure. What matters is the language the dossier is prepared in, the assessors’ experience in the relevant therapeutic area, and the working history already built with that regulator on other products in the portfolio. A poor choice lengthens the whole cycle: if the reference state requests data that isn’t in the dossier, answering the query delays registration in every state of recognition at once.
It’s worth separating two terms that are often confused. The Council of the EEC is the Commission’s senior body; its decisions, including Decision No. 78, carry the greatest legal weight among EEC acts. The Board of the EEC is the Commission’s standing regulatory body; its decisions and recommendations spell out the norms the Council adopts and cannot conflict with them. Mixing the two up matters in practice: citing the wrong body is a common finding during review.
The dossier is compiled in the CTD format across five modules: administrative information (specific to each country), CTD summaries, quality data, non-clinical study reports, and clinical study reports. The electronic dossier (eCTD) is an XML structure with links between documents and a history of every version submitted. A plain set of PDF files does not substitute for that structure. The reference state’s assessment report relies on this structure directly, so a missing or malformed link between modules slows review just as much as a missing document would.
Many national dossiers were put together in the 1990s and 2000s under simplified rules. Such dossiers often lack process validation reports and detailed pharmacokinetic data, which Modules 3 through 5 require. That is the main technical reason dossier alignment takes months. Companies that kept their original study archive from first registration move through the procedure faster than those that have to commission bioequivalence studies after the fact.
What This Means for Foreign Manufacturers
For companies entering the EAEU market for the first time, the gap between the national and the Union model feels wider than it does for companies that have worked in Russia for years. In the past, a manufacturer could start in one country, test demand, and register the product in the other four later. The reference state logic requires the opposite from day one: the applicant locks in the full list of states of recognition in the first application, and adding a country later is harder than planning for it up front.
The practical consequence: choosing the authorized representative and the dossier language becomes part of the market entry strategy from the earliest stages, well before the first filing. A company that prepares its dossier in Russian from the start, built around the five CTD modules, saves months compared with one adapting a European or Asian dossier at the last minute.
The 2025-2026 Transition Period
The original rules set a hard line: national marketing authorizations for which no alignment procedure had started would remain valid no later than 31 December 2025. Decision of the EEC Council of 22 May 2025 No. 34 (hereinafter, Decision No. 34), which entered into force on 21 June 2025, softened that line and introduced three cases for extension. Decision of the EEC Council of 12 September 2025 No. 77 later refined the wording for each of those cases. Note: this is a separate act from the GMP rules discussed further below, which happen to carry the same number, Decision No. 77, but were adopted back on 3 November 2016. This article cites each by its full date to keep the two apart.
If the alignment procedure was never started, the national MA stays valid until the expiry date printed on it, with an absolute cutoff of 31 December 2025. Batches already produced can still be sold until they reach the end of their shelf life.
For the two remaining cases, what matters is which track the filing took. The first track is the standard dossier alignment procedure. The second, narrower one, is an application to amend the dossier and add states of recognition where the product was already registered elsewhere in the Union.
If an application was filed with the reference state before 31 December 2025 under either track, the national MA’s validity is extended for the length of the review. The extension applies in every named member state and cannot exceed three years from the filing date in the reference state. On top of that, up to two more years are available to finish the procedure in the states of recognition. That second, two-year clock starts from the filing date in the state of recognition itself, not from the reference-state filing date; the only condition is that the recognition-state filing happens no later than three years after the reference-state one.
If the procedure under the first track was already completed in the reference state before 31 December 2025, or the procedure under the second track had at least been started by that date, the MA in the named states of recognition is extended for the time needed to finish that procedure. That extension is capped at two years from 31 December 2025.
Here is how these cases play out in practice. A company files with the reference state on 15 December 2025 and names three states of recognition. The maximum review period in the reference state runs until 15 December 2028. If the company files with the states of recognition earlier, say in February 2026, its own two-year window to close out the procedure there starts running from February 2026.
Waiting until the three-year deadline to file with the states of recognition doesn’t extend that two-year window. It only pushes back when the window can start, and with it, the final date the whole extension runs out.
The End of National GMP Rules
As of 1 March 2026, Order No. 916 and its amendments no longer apply. Site inspections and GMP certificates are now issued only under the EAEU Rules of Good Manufacturing Practice, approved by Decision of the EEC Council of 3 November 2016 No. 77 (hereinafter, Decision No. 77).
The process did not wrap up in one step. Decree of the Government of Russia of 11 June 2026 No. 724 stripped the Ministry of Industry and Trade of its remaining authority to approve national GMP rules and keep a register of national compliance findings. The decree implements Federal Law of 31 July 2025 No. 304-FZ and finally removes Decree of the Government of Russia of 3 December 2015 No. 1314, which used to govern these checks nationally, from the legal framework.
Decision No. 34 also eased the timing requirement for the certificate itself: if an EAEU GMP certificate isn’t ready yet at the point of registration or alignment, an applicant can submit the manufacturer’s home-country national certificate along with a set of supporting documents. Site compliance with EAEU GMP rules then has to be confirmed within three years of registration. If that deadline is missed, the regulator can refuse registration or suspend the marketing authorization.
Comparing the Two Models
| Parameter | Before (61-FZ, national model) | Now (Decision No. 78, EAEU) |
|---|---|---|
| Who runs the evaluation | Russia’s Ministry of Health and its expert institution | Reference state, then states of recognition |
| Territory the MA covers | Russian Federation only | Reference state and named states of recognition |
| Dossier format | Paper volumes or PDF scans | CTD, five modules, electronic |
| GMP rules | Order of the Ministry of Industry and Trade No. 916 (repealed 1 March 2026) | Decision of the EEC Council No. 77 |
| GMP certificate | National, valid only in Russia | Single EAEU-format certificate, recognized across the Union |
| Legal basis | 61-FZ | Treaty on the EAEU, Decision No. 78 |
| Procedures to enter all 5 Union markets | Five separate national registrations | One evaluation in the reference state plus recognition |
| Choice of evaluating country | Not applicable; evaluation only in Russia | Manufacturer chooses the reference state |
Action Plan
Check the status of every registration dossier.
Split the portfolio into three groups:
alignment procedure completed before 31 December 2025;
application filed with the reference state before 31 December 2025, review ongoing;
no application filed.
The group determines which of the three extension cases under Decision No. 34 applies, and how much time is left to finish the procedure.
Lock in the reference state and states of recognition. For new registrations and unfinished alignment procedures, confirm which state is named as the reference state and which countries appear as states of recognition. This sets the geography of the future MA, and for filed applications, the deadline for filing with the states of recognition, counted from the reference-state filing date.
Run a gap analysis of the dossier against the five CTD modules. Pay particular attention to Modules 3 through 5: process validation data, non-clinical data, and clinical data are most often missing from older national dossiers and may require new studies. Note, module by module, what’s already in the archive and what needs to be commissioned.
Confirm the site against EAEU GMP rules. If the EAEU GMP certificate isn’t in hand yet, check whether the company is using the three-year window available under Decision No. 34, and book the inspection early. Factor in that the request itself takes time: member-state inspectorates build up a queue in advance.
Track the MA extension in the register. Authorities don’t publish extensions to national certificates instantly. Check status regularly in the state register of medicines rather than relying on the date printed on the certificate itself.
Companies that started the alignment procedure in early 2025 bought themselves time to work through assessor queries and close gaps in Modules 3 through 5. Those that put off filing until the last weeks of December ran into a queue at the reference states and had less room to fix review comments. Companies that never filed by 31 December 2025 lost the right to sell under the old MA and now have to register from scratch, under the full Decision No. 78 procedure.
The next chapter for 61-FZ is a narrower scope. The law still governs what remains a national matter: pharmaceutical licensing, retail trade, and the handling of narcotic and psychotropic medicines. Registration and evaluation of medicinal products for human use have moved to Decision No. 78 entirely. The next articles in this series work through that decision clause by clause, show how to choose a reference state for a given portfolio, and walk through the logic of each of the five dossier modules.
Regulatory framework:
1. Treaty on the Eurasian Economic Union of 29 May 2014
2. Federal Law of 12 April 2010 No. 61-FZ, «On the Circulation of Medicines»
3. Decision of the Council of the EEC of 3 November 2016 No. 78, «On the Rules for Registration and Examination of Medicinal Products for Human Use»
4. Decision of the Council of the EEC of 22 May 2025 No. 34, «On Amendments to Decision of the Council of the Eurasian Economic Commission of 3 November 2016 No. 78»
5. Decision of the Council of the EEC of 12 September 2025 No. 77, «On Amendments to Decision of the Council of the Eurasian Economic Commission of 3 November 2016 No. 78» (a separate act from the next entry, despite sharing the same number)
6. Decision of the Council of the EEC of 3 November 2016 No. 77, «On the Approval of the Rules of Good Manufacturing Practice of the Eurasian Economic Union»
7. Order of the Ministry of Industry and Trade of Russia of 14 June 2013 No. 916, «On the Approval of the Rules for the Organization of Production and Quality Control of Medicinal Products» (repealed 1 March 2026)
8. Decree of the Government of Russia of 11 June 2026 No. 724
9. Federal Law of 31 July 2025 No. 304-FZ