On June 9, 2025, updated rules for the circulation of medicinal products and pharmaceutical substances came into force in Russia. RF Government Resolution No. 815 of May 31, 2025 replaces the previous regulation (No. 1510 of November 29, 2019) and introduces a number of important adjustments.
Unification of regulation of pharmaceutical substances
Now the requirements for pharmaceutical substances fully comply with the standards applied to medicinal products. Manufacturers are required to submit documentation confirming the quality of each batch produced to Roszdravnadzor. Importers must provide similar documents from foreign manufacturers. Data on substances permitted for circulation will be recorded in a single register.
Remote quality control
For the first time, the possibility of conducting remote tests has been enshrined in law. This is permissible in the following cases:
– the laboratory lacks the necessary equipment,
– impossibility of transporting or storing samples,
– risk of spoilage of the entire batch during in-person inspection,
– the need to assess quality parameters exclusively at the production site.
A decision on an application for distance learning is made within 5 working days.
Features for immunobiological preparations
A separate procedure for issuing permits for introduction into circulation and issuing certificates of conformity for this category of drugs has been approved.
Withdrawal of lots from circulation
The grounds and mechanism for stopping the circulation of drug series, including the procedure for their recall from the market, are clearly regulated.
Important: the new rules come into force on June 9, 2025. Pharmaceutical market participants are advised to familiarize themselves with the changes in advance in order to adapt their processes to the updated requirements.
