Are You Ready for EAEU? Countdown to the Deadline – December 31, 2025 Current Status and Next Steps Checklist.
Evaluate the registration status (original, generic, combined etc.) of your product in all EAEU countries.Are You Ready for EAEU? Countdown to the Deadline – December 31, 2025
Current Status and Next Steps Checklist.
As the deadline of December 31, 2025 approaches for bringing all medicinal products into compliance with Eurasian Economic Union (EAEU) requirements, otherwise called as upgrade procedure, it’s crucial to assess the current status and outline the next steps.
How It Started and Where It Stands?
In January 2015 the Eurasian Economic Union has been formed, which consists of the following member states: Russia, Kazakhstan, Belarus, Kyrgyzstan, Armenia.
The Eurasian Economic Union (EAEU) has established a unified regulatory framework for medicinal products, aiming to harmonize the standards and processes related to the registration, production, and distribution of pharmaceuticals among its member states.
There is a transition period until the end of 2025, during which all EAEU member countries must bring all documentation of the locally registered medicinal products into compliance with the rules of the union. From January 1, 2026, all registration certificates for medicines issued in accordance with the national legislation (NAT) of the EAEU member states will be cancelled (Decision 78, article 2,d).
Medicinal products imported before the deadline, but not brought into compliance can still stay in circulation after December 31, 2025, on the territory of a member state until the end of shelf life. No regulatory activities allowed for those products (Decision 78, article 164).
There is a grace period of 180 calendar days after the approval of upgrade procedure for production and importation of products according to previous Marketing Authorization issued under national requirements of the Member State.
Overall, the EAEU regulatory requirements are still being updated and there are simplifications implemented recently to reduce the administrative burden for applicants and accelerate the process. Thus, according to Decision 114 from October 2023, the M1 now needs to be submitted electronically, with the only exception of application form. Notarized copies are no longer required. Additionally, a few sections of M1 have been excluded, and some have been made non-mandatory.
What are the Current Challenges?
Despite progress, there are several challenges that the applicants face in fully implementing EAEU regulations for their medicinal products:
- Regulatory Divergence: Despite efforts to harmonize, some local approaches still differ, complicating the unified framework.
- Implementation Delays: The practical implementation of these regulations across different countries with varying levels of regulatory infrastructure can lead to delays.
- Political and Economic Factors: Political tensions and economic disparities among member states can affect the collaborative efforts needed for a successful common market.
Will the Pharmaceutical Industry Align with EAEU Regulations by December 31, 2025?
According to a report from February 2024 by the Expert Organization of Kazakhstan, only a small fraction of registered medicinal products across EAEU member states have been upgraded in line with the EAEU regulations. The specific figures demonstrate this trend: Kazakhstan has transitioned 5.1% of its products, Armenia 4.6%, Belarus 5.8%, Kyrgyzstan just 2.5%, and Russia, leads with 27%.
The timelines for the upgrade procedure are:
- Referent member state (RMS): 70 w.d. + 90 w.d. clock stop*
- Country of recognition: 90 cd + 90 cd clock stop.
* 2nd DL is only possible as exception in case of additional questions to the documents submitted as an answer for the 1st DL, the total clock stops cannot exceed 180 w.d
Obviously, the remaining time of 1.5 year is not enough to finalize transition of all currently registered medicines in member states from national registration to EAEU. This situation poses a risk of drug shortages in the territories of EAEU member states. Therefore, to preserve previously issued Marketing Authorizations, Kazakhstan authorities have initiated an amendment to the Agreement to extend the transition period. However, it was not supported. All decisions within the EAEU are made based on consensus, i.e. if one country votes against, the decision is not made. Despite that, the proposal has been re-sent for additional discussion by the EAEU member states.
Considering the above-mentioned, we strongly recommend actively preparing for the upgrade at least in RMS, so that to save the MA at least in the main market and further do geographical extension in others. The timelines are exceptionally tight, especially considering that dossier preparation can take an additional time of 2 to 6 months, depending on the quality of the dossier.
So, what shall be done NOW? Refer to our Checklist for the essential steps:
EAEU upgrade CHECKLIST:
- Perform Portfolio Assessment:
- Evaluate the registration status (original, generic, combined etc.) of your product in all EAEU countries.
- Identify product strengths, dosage forms, and shared package presentations.
- Confirm and align your marketing plan accordingly.
- Choose a Referent Country
- Select countries with advanced regulatory experience (e.g. Russia, Kazakhstan, Belarus).
- Choose the appropriate country for your product based on registered indications, pack sizes and forms*.
- Conduct Dossier GAP Analyses:
- Compliance with EAEU Rules: Ensure Modules M1-M3 correspond to EAEU requirements**.
- Pharmacopeia Compliance: Verify that M3 meets EAEU pharmacopeia standards.
- Clinical Trials Compliance: Confirm the availability of non-clinical and clinical trials for each registered indication, including post-registration trials for effectiveness and safety. M2 may require revision taking into account the regulatory status (original, generic, combined etc.).
- GMP Certification Compliance: Check the availability and validity of the National or EAEU GMP certificate (national GMP certificate accepted until Dec 31, 2024). Submit application for EAEU GMP certificate in one of the EAEU member states if it is not available***.
- Dossier Format Compliance: Be sure the dossier is converted to EAEU specific XML format before submission.
- Perform Readibility User Testing (RUT)
- Consider country language preferences based on registration plan****.
- Recommended to perform the testing after HA comments received within dossier review.
Notes:
*No harmonization is required; the countries of recognition will refer to referent member country data.
**M4 and M5 are not mandatory for submission in case of dossier upgrade in RMS only
***EAEU GMP inspection is site specific, while national GMP inspection is product specific. Validity of EAEU GMP certificate is 3 years.
****Currently, RUTs are required in Russian and Kazakh languages
Outcome.
Given the unpredictable outcomes of the current geopolitical situation, the slow progress in implementing EAEU rules across member states, and the practical challenges in accepting export reports between member states, the future impact on the pharmaceutical industry within the union remains uncertain. However, with over 15 years of experience of our team in the EAEU and other CIS countries, we can provide valuable insights on how to navigate these challenges and offer detailed answers to your specific questions.