In the spring of 2022, in connection with the introduction of economic restrictive measures against the Russian Federation, the Government of the Russian Federation issued Resolutions regarding the specifics of the circulation of drugs in the event of a inventory shortage or the risk of a inventory shortage (No. 593), as well as on the specifics of introducing changes to the documents contained in the registration dossier for a registered medicinal product in case of a inventory shortage or risk of a inventory shortage (No. 440).

Inventory shortage– absence of the necessary goods (medicinal products) in the pharmacy (pharmacy institution).

Inventory shortage or the risk of drug inventory shortage with the indication the names (international non-proprietary, or chemical, or their grouping forms), dosages, the presence of therapeutic analogues and in other cases of circulation of the medicinal product, are determined by the interdepartmental commission.

The Interdepartmental Commission consists of representatives of the Ministry of Health of the Russian Federation, the Ministry of Industry and Trade of the Russian Federation, the Federal Customs Service, the Federal Service for Surveillance in Healthcare and other interested federal executive bodies.

The decision of the interdepartmental commission is drawn up in a conclusion in the approved form, and information about the decisions of the interdepartmental commission is posted on the official website of the Ministry of Health of Russia.

Due to the possible risk of inventory shortage of some drugs, the concept of “therapeutic analogue” is introduced – a drug whose international non-proprietary name is registered in the Russian Federation, including the one that was previously registered in the Russian Federation and in respect of which a decision was made to cancel state registration in accordance with paragraphs 2 8 of Article 32 of the Federal Law “On the Circulation of Medicines”, belonging to the same pharmacotherapeutic group, acting on the same biotarget (or its receptor) and used for one of the indications as the drug, in respect of which the interdepartmental commission has established a inventory shortage or risk its occurrence.

Therapeutic similarity is established by the interdepartmental commission.

Decree No. 593 is valid until December 31, 2023.

References:

1. Materials of the SCIENTIFIC-PRACTICAL CONFERENCE “MODERN APPROACHES TO THE EXAMINATION AND REGISTRATION OF MEDICINES” REGLEK — 2022
2. Decree of the Government of the Russian Federation of 05.04.2022 N 593 “On the peculiarities of the circulation of medicinal products for medical use in the event of a inventory shortage or the risk of a inventory shortage in medicinal products in connection with the introduction of economic restrictive measures against the Russian Federation”
3. Decree of the Government of the Russian Federation of March 23, 2022 N 440 “On approval of the specifics of making changes to the documents contained in the registration dossier for a registered medicinal product for medical use in the event of a inventory shortage or risk of a inventory shortage in medicinal products in connection with the introduction of restrictive economic measures against the Russian Federation character”