Monitoring the relevance of instructions for drugs: plans of the Ministry of Health of the Russian Federation

Often on the website of the State Register of Medicines (GRLS) messages appear for marketing authorization holders (MAHs) with recommendations for updating documentation for consumers regarding the effectiveness and safety of drugs. However, according to data from Elena Shubnikova, chief expert of the Office of Drug Safety Expertise of the Scientific Center for Emergency Medicine of the Ministry of Health of the Russian Federation, only a quarter of the medical institutions complied with the recommendations of the Ministry of Health of the Russian Federation in two years.

There are several reasons for such low rates of updating instructions: firstly, the amount of fees for making changes with an examination is 490,000 rubles. Many MAHs tend to group changes and submit one dossier, which can lead to some delays; some MAHs completely ignore the recommendations, since the recommendations are not mandatory.

In this regard, the Ministry of Health of the Russian Federation is considering the possibility of introducing precise deadlines for the implementation of recommendations. In case of violation of the deadlines for updating the dossier, the marketing authorization (MA) for the drug may be suspended or revoked. However, no official information has yet been received from departments on this matter.

In addition, from January 1, 2026, the norms from the order of the Ministry of Health of the Russian Federation No. 615n dated September 15, 2022 will come into force, according to which failure to submit an application for amendments to the instructions according to the recommendations of the Ministry of Health within the prescribed period will be a direct basis for suspending the use of drugs.

It is worth noting that even according to current legislation, namely Federal Law No. 61 “On the Circulation of Medicines”, Art. 1.5. MAH is obliged to submit an application for amendments within 40 working days from the date of posting the information on the GRLS. However, the issue of MAH’s liability in case of failure to fulfill obligations remains open.