Draft amendments to the rules for registration of medicines in the EAEU have been published
The draft decision of the Council of the Eurasian Economic Commission "On Amendments to the Decision of the Council of the Eurasian Economic Commission dated November 3, 2016 No. 78" has been published on the Legal Portal of the Eurasian Economic Union . The Order of the Board of the EEC No. 46, dated April 14, 2025, is a draft amendment to the Rules for the Registration of Medicines for Medical Use.
Key aspects of the change project:
Extension of the validity of national registration certificates: One of the most significant innovations is the preservation of the validity of national registration certificates (RC) in the EAEU member countries after December 31, 2025. This will be possible subject to the submission of an application to bring the registration dossier into compliance with the Union requirements in the reference member country with the mandatory indication of the countries of recognition.
Extension period : Extension of validity of national residence permits is possible both in the reference state (for a maximum of 3 years from the date of application) and in the recognition states (for a maximum of 2 years from the date of submission of documents to the recognition state).
It is important to note that the transition period itself until December 31, 2025 remains unchanged, as it is fixed in the Agreement on uniform principles and rules for the circulation of medicines within the EAEU.
Indefinite GMP clause : Clause 30 of the Registration Rules, which allowed, instead of providing the EAEU GMP certificate, to provide a package of supporting documents and an obligation to undergo inspection within 3 years after receiving the RC, has become indefinite. It is noted that clause 159 establishes stricter requirements regarding the consequences of failure to fulfill this obligation.
Update to the expert report format: The format of the expert report and its appendices has been significantly revised and expanded taking into account the practice of authorized bodies and expert organizations. Appendix No. 16 to the Registration Rules is a form of expert report on the assessment of safety, efficacy and quality of a medicinal product . Numerous changes have been made to the document concerning various aspects of the assessment, including quality aspects, preclinical and clinical aspects, and the assessment of the benefit-risk ratio.
Amendments to the registration dossier: The draft provides for the possibility of amending the registration dossier in the reference state during the recognition procedure in the recognition states. The approaches to amendments relating exclusively to recognition states have also been clarified.
These changes are aimed at optimizing the registration processes and bringing registration dossiers of medicines into compliance with the unified requirements of the EAEU, as well as ensuring continuous access of patients to the necessary medicines. It is expected that the adoption of these changes will simplify the transition to a unified registration system and eliminate potential barriers to the circulation of medicines in the Union.
The draft decision of the EEC Council has been published for review and further discussion by interested parties. This order will enter into force on the date of its publication on the official website of the Eurasian Economic Union. The decision of the Council of the Eurasian Economic Commission will enter into force upon expiry of 30 calendar days from the date of its official publication, applying to legal relations that arose from January 1, 2024.