January 21, 2026
Is the harmonization of dossiers with the requirements of the EAEU coming to the end?
Has the procedure for bringing registration dossiers for medicines in line with the requirements of the EAEU (harmonization) come to an end? It is no coincidence that there is a question mark at the end of this sentence. At the time of mid-November 2025, according to Ekaterina Rychikhina, head of the control and organizational department of the Federal State Budgetary Institution "National Center for Expertise of Medical Devices" (SCEEMP) of the Ministry of Health of the Russian Federation, out of about 17,200 drugs, less than 2,500 must undergo the dossier adjustment procedure, and this procedure has already been initiated for 10,605 drugs.
Nevertheless, important questions were raised at the REGLEK 2025 conference regarding the fate of medicines that were not brought into compliance in 2025.
For example:
-
How will drugs for which harmonization has not yet been completed be treated? What will be their status on the GRLS (local Russian register)?
This issue is regulated in different ways in the EAEU member states. For example, in the Republic of Belarus, in the "Expiration date" column of some drugs in the national registry, there is a note about the extension, but there is no information about the completion of the harmonizationn procedure.
In Armenia, a register is published with marks on the assignment of status to drugs for which the examination has not been completed, and drugs for which applications have not been submitted are also noted in the document. As of November 1, 2025, there were 3,667 registration certificates (RC) in the register of Armenia, of which 766 have the EAEU RC, 1,254 are in the process of being adjusted, and 1,647 have no applications. In October, there were 1,785 of them.
-
How will drugs for which harmonization was not initiated be sold, but they were manufactured before 31.12.2025 and, according to the legislation, can be traded on the market before the expiration date?
On the second issue, a letter from the Ministry of Health of the Russian Federation was published on the GRLS portal at the end of November, according to which:
"... it is allowed to sell medicines whose registration certificates have expired before the expiration date (shelf life) of these medicines, if they were produced before the expiration date of the registration certificate."
According to the same letter, applicants for registration and manufacturers were asked to inform the Ministry of Health of the Russian Federation and Roszdravnadzor of their intention to initiate the PVS procedure. There were 1,131 legal entities on the list for informing the Ministry of Health of the Russian Federation.
Materials of the scientific and practical conference "REGLEK 2025", November 17-19, 2025.
