On 6 May 2025, the updated version of the Order of the Ministry of Health dated 9 February 2016 No. 80n “On the Approval of the Procedure for Maintaining the State Register of Medicines for Medical Use” (the “Order”) came into force. The amendments were made in accordance with Order of the Russian Ministry of Health dated 17 March 2025 No. 129n, officially published on 25 April 2025.
The key changes include the following:
1. The provisions on the information contained in the registry entry for pharmaceuticals and active pharmaceutical ingredients (including those manufactured for sale) have been clarified – it must include information on the status of the MA holder as a taxpayer (TIN for Russian companies, country of registration and taxpayer code (or its equivalent) for foreign organisations).
2. Information on the interchangeability of a pharmaceutical and the date of its entry into civil circulation is excluded from the registry entry.
3. The register shall include information on whether the pharmaceutical is orphan, immunobiological, radiopharmaceutical, homeopathic, biological, and whether it has the status of a high-tech pharmaceutical first registered in the Russian Federation in accordance with national rules or EAEU acts.
4. For active pharmaceutical ingredients (including those manufactured for sale), the registry entry is supplemented with information on the form of release (indicating the dosage (if available), filling and finishing.
The following changes will come into force on 1 January 2026:
1. The list of cases when information about pharmaceuticals is subject to exclusion from the state register is reduced. The following grounds are excluded:
-
failure to confirm state registration of a pharmaceutical upon expiry of the registration certificate issued for 5 years;
-
failure by the applicant to provide information that may necessitate changes to the documents contained in the registration dossier for a registered pharmaceutical within 30 business days of the date of such changes;
-
state registration of a pharmaceutical under a trade name previously registered under this trade name for a pharmaceutical differing in the qualitative composition of the active ingredients;
-
state registration by the applicant of the same pharmaceutical under different trade names;
-
absence of a pharmaceutical in circulation in the Russian Federation for 3 years or more.
2. The MA holder may submit an application for cancellation of state registration of a pharmaceutical or active pharmaceutical ingredient manufactured for sale through the Single Portal of State and Municipal Services.
3. Similarly, the absence of an active pharmaceutical ingredient manufactured for sale in circulation in the Russian Federation for 3 years or more is also excluded.