Raifarm informs the professional community about the key aspects of the transition to the unified Eurasian Economic Union (EAEU) rules for the regulation of medicinal products for human use.
According to the approved provisions, marketing authorisation dossiers of medicinal products authorised under national procedures of the EAEU Member States must be brought into full compliance with the Union requirements by December 31, 2025.
The Council of the Eurasian Economic Commission (EEC) has laid down the relevant transitional provisions in Decision No. 34 dated May 22, 2025, which amend the unified marketing authorisation rules. The document stipulates that national marketing authorisations (MAs) issued before the end of 2025 will remain valid until their expiry dates and beyond this date, provided certain conditions are met. For products for which applications for alignment with EAEU rules were submitted by December 31, 2025, the validity of the MAs is extended:
* For up to three years in the reference Member State (from the application date).
* For up to two years in the Member States concerned (from the application date in the respective country).
Applications to the Member States concerned must be submitted no later than the expiration of the three-year period from the application date in the reference Member State.
EEC experts previously noted1 that with timely submission of documents, “no unexpected issues are anticipated.” Market participants and regulators will receive information about the extension of MAs from the national state registers of medicinal products.
In 2026, national MAs are expiring, and the transition to EAEU MAs will begin. According to expert estimates, in Russia, the full MA renewal procedure is expected to be completed by January 1, 2026 for only about half of the active entries in the State Register of Medicinal Products (SRMP - https://grls.minzdrav.gov.ru/Default). For the other half of the products, MA holders have either just started submitting documents or do not plan to do so. The situation appears to be significantly more complex in other EAEU markets.
Although medicines that do not receive a new EAEU MA may remain on the market until their expiry dates if they were placed on the market before December 31, 2025, the pharmaceutical community is concerned about the accurate reflection of the authorisation status of products for which no submissions under EAEU rules are planned.
Stocks of such products will remain in manufacturers’ and distributors’ warehouses, healthcare facilities, and pharmacies. Their sale should be permitted until expiration. For example, in the Russian market, incorrect display of information in the SRMP could lead to an increase in the VAT rate from 10% to 20% for such products, as well as the risk of companies being excluded from the public procurement system and losing tax benefits. At the end of 2025, the Association of Russian Pharmaceutical Manufacturers appealed to the Minister of Health of the Russian Federation with a request to expedite the entry of data on the extension of national MAs into the SRMP.
Expert organisations within the EEC working group announced plans for a stepwise synchronisation of information on products with extended MAs in the period from November 2025 to February 2026.
Currently, it is planned to update the records regarding the validity of the national authorisation document in the registers for products already brought into compliance with EAEU requirements, as well as for those submitted for alignment before the end of 2025. Subsequently, data synchronisation between the reference Member State and the Member States concerned will be carried out as the MA dossiers progress through the alignment procedure.
Respectfully,
The RaifarmTeam
Author: Anastasia Kataeva