Experts from the Scientific Center for Expertise of Medicinal Products (SCEEMP) of the Russian Ministry of Health are drawing the attention of pharmaceutical market participants to the systematic violation of requirements for updating registration documentation for generic, hybrid, and biosimilar drugs. Many marketing authorization holders (MAHs) ignore the established deadlines for making changes, which creates risks for consumers and regulatory consequences for the companies themselves.
The essence of the requirements:
In accordance with Decision No. 88 of the Council of the Eurasian Economic Commission dated November 3, 2016, the holder of a registration certificate for a generic or biosimilar drug is required to make the appropriate amendments to its own documentation within 120 working days of any changes to the instructions or characteristics of the reference (original) drug, including:
– General characteristics of the medicinal product (GCMP);
– Instructions for medical use (IMU);
– Package leaflet (PL).
An audit conducted by the National Center for Expertise and Medical Protection of Medicines (NCESMP) of a number of international nonproprietary names (for example, azithromycin, linezolid, glucosamine) revealed widespread cases of non-compliance.
Potential consequences of failure to comply:
Failure to comply with these requirements may result in serious regulatory action beyond administrative fines:
– Suspension of the registration certificate;
– Complete cancellation (annulment) of the RU;
– Introduction of restrictions on the use of the drug.
Once a non-compliance is identified, the regulator will issue a formal order to correct the violation within a short timeframe, but by that time, the reputational and financial damage to the company may be significant.
Recommendations for RU holders:
An urgent audit of registration dossiers across the entire product portfolio is necessary. Current versions of the IMP and SmPC should be compared with the current reference product documents, with particular attention to the amendments published by the Russian Ministry of Health in 2024–2025. Compliance with established regulations is essential for maintaining the legal status of drugs on the market and minimizing risks to businesses.
