EAEU Drug Registration Deadline Has Passed. Three Ways a Product Leaves the Market in 2026
The first half of 2026 has made one thing clear: not all companies correctly understood what the «extension of the transition period until 2027» actually means. Some perceived it as another breathing space. Others continue to frantically compile dossiers. The gap between these two groups will become obvious by the end of 2027: some drugs will quietly disappear from the market without any official «recall.»
To understand what exactly each drug is risking, one must examine how the deadline system works under the current edition of EEC Council Decision No. 78. The mechanism is multi-layered, and it is precisely within these layers that the traps are hidden.
How the System Was Structured Before December 31, 2025
When the EEC Council adopted Decision No. 78 in 2016, establishing the unified Rules for Registration and Examination of Medicinal Products for Human Use (hereinafter the Rules), the EAEU member states were granted a transition period. The logic was straightforward: all drugs registered under national rules before the document entered into force had to undergo the procedure of bringing the registration dossier into compliance with Union requirements (Section XIII of the Rules) and transition to a unified marketing authorization (MA). The established deadline was December 31, 2025.
Until July 1, 2021, applicants could choose whether to register a drug under EAEU rules or national legislation. After that date, new drugs are registered only under the unified rules. Older products listed in national registries remained in a waiting mode.
Many overlooked the following: MAs issued under national rules before July 1, 2021, could be renewed under national legislation, but no later than December 31, 2025. Introducing variations to such dossiers was also permitted in the previous manner — again, up to the same deadline.
Companies operated under this regime for ten years. The result turned out to be unexpected even for the regulator: by the time the deadline arrived, a significant portion of the market had not brought its dossiers into compliance. According to various estimates, by March 2024, only around 6,500 applications for bringing into compliance had been submitted, out of tens of thousands of potential products.
Why did this happen? Several factors converged simultaneously. The processing capacity of expert organizations was limited, and the queue of applications stretched for years. Some companies discovered that old dossiers could not be brought into compliance without conducting new studies — primarily bioequivalence and stability. Others simply procrastinated, counting on yet another deadline extension. Geopolitical turbulence in 2022–2024 shifted priorities: ensuring the physical availability of drugs in pharmacies came first, and updating dossiers came second.
What Changed in 2025
Three decisions of the EEC Council, adopted throughout 2025, successively reshaped the logic of the transition period. First came Decision No. 34 of May 22, then No. 77 of September 12, followed by No. 93 of November 26. All three amended Decision No. 78.
If an application to bring a dossier into compliance was submitted before December 31, 2025, the national MA continues to be valid throughout the duration of the procedure. However, this is not indefinite: the maximum is 3 years from the date of submitting the application to the reference state. On top of this, no more than 2 additional years are available for completing the procedure in the states of recognition, provided that the application there is submitted no later than 3 years from the date of submission to the reference state. This is established by subparagraph «f» of paragraph 2 of EEC Council Decision No. 78 as amended by Decision No. 77.
If the application was not submitted by December 31, 2025, the national MA ceased to be valid on that very day. This is precisely how it is written in subparagraph «e» of paragraph 2 of the Council Decision as amended by Decision No. 34.
At the Russian national level, another layer was added. By Government Decree No. 1851 dated December 21, 2024, MAs issued before December 26, 2024, with an expiration date of December 31, 2024, were automatically extended until December 31, 2027, without the need to replace physical certificates. RF Government Decree No. 593 itself is valid until December 31, 2027. Temporary marketing authorizations issued before January 1, 2025, were extended for the same period.
It is easy to get confused with terminology here. The EAEU Rules (Paragraph 170, first paragraph) require the application for bringing into compliance to be submitted by December 31, 2025. This is a hard deadline, not a tentative one. Companies arguing that «everyone was given time until 2027» are confusing two distinct events: the deadline for submitting the application (which passed on December 31, 2025) and the deadline for completing the procedure (up to the end of 2028–2030 for those who submitted on time). For those who did not submit, there is no «until 2027.»
| Drug situation | MA status after 01.01.2026 | Legal basis |
|---|---|---|
| Application submitted before 31.12.2025 | Valid until completion of procedure (max. 3 years in the reference state + 2 years in states of recognition) | Subparagraph «f», para. 2, EEC Council Decision No. 78 (as amended by Decision No. 77) |
| Application not submitted; drug placed on the market for at least 3 years as of 01.12.2025 | In Russia: circulation permitted until 01.01.2027 | Note to para. 170 of the Rules; RF Government Decree No. 353 dated 12.03.2022 |
| Application not submitted; no other grounds | MA ceased to be valid on 31.12.2025 | Subparagraph «e», para. 2, EEC Council Decision No. 78 (as amended by Decision No. 34) |
| Registered under RF Government Decree No. 593 (emergency procedure) | Valid until 31.12.2027 | Para. 3, RF Government Decree No. 593 (as amended by Decree No. 1964 dated 28.12.2024) |
Three Scenarios in Which a Drug Leaves the Market
An official «recall» is a loud, public story involving a press release and a directive from Roszdravnadzor. Far more often, a drug simply ceases to exist legally: through the expiration of its MA or a rejection during the compliance procedure. Here are three scenarios, each of which is already unfolding right now.
Quiet Discontinuation. A company consciously decided not to submit an application: the drug is low-margin, and the costs of updating the dossier will not pay off. On December 31, 2025, its MA ceased to be valid. Technically, the drug became unregistered on EAEU territory. Existing stocks in warehouses and pharmacies may still be sold until their expiration date — Paragraph 165 of the Rules directly permits this. New batches cannot be manufactured, and new shipments cannot be processed.
This scenario primarily affects low-priced generics, older drugs with dossiers that are difficult to rewrite into CTD (Common Technical Document) format, and products with close substitutes available on the market. According to various expert estimates, between 15% and 20% of the market assortment has fallen into this risk zone.
Procedural Rejection. The company submitted the application on time, but during the regulatory review, the expert organization — in Russia, the Federal State Budgetary Institution «NCSMP» (National Centre for Examination and Standardisation of Medicines and Medical Products, or equivalent national bodies in other member states) — identified serious problems: Module 3 is not compiled in accordance with current EAEU requirements, stability data are outdated, or the manufacturing site failed to pass the EAEU GMP inspection within the required timeframe.
Paragraph 179 of the Rules leaves no room for maneuver: the competent authority rejects the application for bringing into compliance if the quality of the drug is not confirmed. Following rejection, the national MA loses its validity.
This is the most painful path: the company spent money and time, submitted the application on schedule, and still lost the drug. This outcome is typical for drugs registered in the 1990s and 2000s, when evidentiary standards were fundamentally different. In those dossiers, bioequivalence data are often missing, quality control methodologies are written in formats incompatible with EAEU standards, and manufacturing sites have since changed without proper variation filings. Converting such a dossier into CTD format without actually revising a significant portion of the underlying data is simply not feasible.
Inspection Deadlock. The application has been submitted, the dossier is in order, but the manufacturing site has not passed the EAEU GMP inspection. Paragraph 159 of the Rules provides that if a valid document confirming compliance with EAEU GMP standards is absent 3 years after the completion of registration procedures, the competent authority is entitled to suspend the MA. Planned inspection timelines are fixed in Paragraph 31 of the Rules: within the first 3 years after registration.
For foreign manufacturers, this is particularly pressing — queues for GMP inspections with Russian and Belarusian inspectors are stretched to 12–18 months. Companies that were late to act risk missing the final deadline.
There is also a reverse situation. Paragraph 30 of the Rules allows submitting an application without a valid EAEU GMP certificate: instead, documents confirming compliance with the GMP requirements of the country of manufacture and consent to undergo an inspection may be provided. After registration, the inspection must take place within the first 3 years. Companies that used this mechanism in 2024–2025 will face a hard GMP deadline precisely in 2027–2028.
What Happens to Product Stocks
If the MA has expired, is it still permissible to sell what is already sitting in warehouses and pharmacies?
Paragraph 165 of the Rules, as amended by Decision No. 34, answers affirmatively: the sale of drugs with an expired MA is permitted until the end of their shelf life, provided they were manufactured before the expiration of the MA. For those whose MA has been extended under subparagraph «f» of paragraph 2 of the Council Decision, an equivalent rule applies.
A separate category consists of drugs for which no application was submitted at all, but which as of December 1, 2025, had been placed on the market for at least 3 consecutive calendar years. For these, a note in the ConsultantPlus commentary to Paragraph 170 of the Rules provides for continued circulation until January 1, 2027, in accordance with RF Government Decree No. 353.
Putting it all together, the picture looks like this:
| Stock category | Permitted circulation period |
|---|---|
| Drug without application, manufactured before 31.12.2025 | Until end of shelf life (para. 165 of the Rules) |
| Drug under RF Government Decree No. 353 (on market 3+ years, no application) | Until 01.01.2027 |
| Drug with application submitted; procedure ongoing | Until end of shelf life (para. 165, subpara. 2) |
| New batches without a valid EAEU MA | Manufacturing and market placement prohibited |
The main practical risk here is borne by distributors and pharmacy chains. A product with an expired MA and a shelf life running to 2028–2029 can formally be sold. However, no audit or supervisory inspection will be pleased to find it. The MDLP system (monitoring of medicinal product movement) cross-references MA status in the registry when scanning packages, and any discrepancy creates a risk of the product being blocked.
Parallel Track: What Is Happening to Medical Devices
The pharmaceutical market does not exist in isolation. In parallel with the drug transition, a similar process is taking place in the medical devices (MD) sector. As of January 1, 2026, the acceptance of applications for the registration of MDs under national rules has been closed in Russia. The possibility of introducing variations to national dossiers remains open until December 31, 2026. The final expiration of national documents is synchronized with the drug deadline: December 31, 2027.
For companies working with combination products or simultaneously promoting both drug products and MDs, this translates into a double regulatory burden throughout 2026–2027.
The Kazakhstan Factor
The picture across the EAEU as a whole is uneven. Kazakhstan introduced a separate registration procedure for strategically important medicines under national rules back in 2023. By Order of the Minister of Health of the Republic of Kazakhstan No. 146 dated November 18, 2025, this carve-out received direct legislative consolidation: the requirements of subparagraphs «d» and «e» of paragraph 2 of EEC Council Decision No. 78 were explicitly exempted from applying to MAs for strategically important drugs. The transition of such drugs to EAEU rules is voluntary.
This creates a regulatory conflict within the Union. A drug may legally circulate in Kazakhstan under a national MA after 2027, yet be prohibited in Russia and Belarus for lack of an EAEU MA. From the standpoint of pharmacovigilance and traceability, this discrepancy creates fertile ground for parallel trade.
For international companies, this matters when planning strategy across the Union: «unified» registration still requires a differentiated approach in different member states.
What to Do
The middle of 2026 is the last point at which most risks are still manageable.
Conduct a portfolio audit. Extract all active MAs and divide them into three groups. Green: application submitted before 31.12.2025, procedure at the expert center is ongoing. Yellow: MAs under RF Government Decree No. 593 or Decree No. 353, expiring in 2027. Red: application not submitted, legal grounds for continued circulation are unclear. For the red group, a legal opinion must be obtained immediately.
Verify GMP status. For all products in the green group, confirm that the manufacturing site has either already passed the EAEU GMP inspection or that an inspection application has been filed. If the GMP certificate expires in 2026–2027, the re-inspection application must be submitted now.
Track the progress of the procedure. Check the application status for each drug in the green group through the EAEU integrated information system. If the application number is absent from the unified registry, contact the expert body: it is possible that the application was not technically registered.
Resolve the stocks issue. Together with legal counsel and the quality department, compile a register of batches currently in circulation, indicating shelf life and MA status for each. This is essential for audits and interactions with Roszdravnadzor.
Make a decision on the red group. For products where no application has been submitted and there is no economic case for doing so, prepare an official notification of the discontinuation of manufacturing and sales in accordance with Paragraph 167 of the Rules (60 calendar days prior to discontinuation). This is far preferable to waiting for enforcement action from the regulator.
By January 1, 2028, the legal situation will be locked in permanently: drugs will either hold an EAEU MA or leave the market. Both outcomes are predictable and manageable — provided the company has a clear picture of where each product in its portfolio stands.
Regulatory Framework:
1. Federal Law No. 61-FZ dated 12.04.2010 «On the Circulation of Medicinal Products»
2. Decision of the Council of the Eurasian Economic Commission No. 78 dated 03.11.2016 «On the Rules of Registration and Examination of Medicinal Products for Human Use» (as amended by EEC Council Decisions No. 34 dated 22.05.2025, No. 77 dated 12.09.2025, and No. 93 dated 26.11.2025)
3. Decree of the Government of the Russian Federation No. 593 dated 05.04.2022 «On the Specifics of Circulation of Medicinal Products…» (as amended by RF Government Decrees No. 1851 dated 21.12.2024 and No. 1964 dated 28.12.2024)
4. Decree of the Government of the Russian Federation No. 353 dated 12.03.2022
5. Order of the Minister of Health of the Republic of Kazakhstan No. 146 dated 18.11.2025 «On Amending the Rules of State Registration and Re-registration of Medicinal Products or Medical Devices»