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New grounds introduced for the import and sale of unregistered medicines in Russia

In the spring of 2022, the Russian government adopted Decree No. 593* aimed at ensuring the sustainability of drug supply in the context of foreign sanctions. One of the main measures introduced is the possibility to temporarily circulate batches or series of unregistered medicines in Russia on the basis of a special permit from the Ministry of Health (“Permit”).

The novelty primarily concerns medicines that are not registered in Russia, are authorised for use abroad and have analogues registered in Russia with the same international non-proprietary name.

However, this measure could not be applied for a period of time due to the fact a special inter-ministerial commission (the “Commission”), whose decision on the following issues must form the basis for issuing the Permit, had not yet been set up:

  • determining whether there is a shortage of a medicine or the risk it may occur;
  • determining whether a batch or series of unregistered medicine can be circulated temporarily.

The Regulation on the functioning of the Commission was approved by Order No. 339n of the Russian Ministry of Health* and came into force on 7 June 2022. The Commission includes representatives of the Ministry of Health, the Federal Service for Surveillance in Healthcare, the Ministry of Industry and Trade, the Ministry of Finance, the Federal Anti-Monopoly Service and the Federal Customs Service. At the initiative of the Commission, marketing authorisation holders and Permit applicants may participate in its meetings without the right to vote.

Executive authorities and entities involved in the circulation of medicines (e.g. pharmacies, distributors, manufacturers) can be sources of information on unavailability or risk of unavailability of a medicine.

In making its decisions, the Commission takes into account factors such as the withdrawal of marketing authorisations, the risk that manufacturers or suppliers of finished medicines or raw materials may discontinue business.

The decision on the possibility of temporary circulation of a drug must be unanimous.

Conclusion

The Commission is expected to start its activities shortly. This will give foreign companies continuing to operate on the Russian market additional opportunities to supply medicines that are not registered in Russia to meet patients’ needs.

In Russian

Author

Vsevolod Tyupa
Vsevolod Tyupa
Counsel
Head of Life Sciences & Healthcare
Moscow

Co-authored by Ivan Zaraiskiy, Associate in Life Sciences & Healthcare.