Inventory shortage or risk of inventory shortage – update of legislation 2023.
In 2022, the Government of the Russian Federation developed a number of regulations regarding the circulation of medicines for medical use in the event of inventory shortage or risk of inventory shortage of medicinal products (Orders No. 593, PP No. 440, Order No. 339n).
On February 13, 2023, Order No. 724n “On Amendments to the Regulations on the Interdepartmental Commission N 339n for Determination of inventory shortage or risk of inventory shortage of medicinal products in Connection with the Introduction of Restrictive Economic Measures against the Russian Federation” was registered.
The document expanded the grounds for recognizing inventory shortage of medicines. In particular, it is added a refusal to supply pharmaceutical substances, excipients and consumables, as well as standard samples, equipment and drugs themselves.
In addition, the shortage of medicinal products will be recognized if:
- There is a risk of termination of activities of one or more participants in the production of medicinal products or participants have already ceased their activities;
- The state registration of the drug was cancelled.
It is also noted in the Order that the subjects of medicinal product circulation can participate in the discussion at the meeting of the interdepartmental commission of the presence or absence of inventory shortage. For this purpose, it is necessary to send a corresponding notification to the e-mail address: email@example.com within 3 working days.
In addition, the Appendix to this order contains the form of the Proposal for determining the shortage or the risk of inventory shortage of the medicinal product. According to the Proposal form, two issues can be brought up for discussion: recognition of a product shortage or withdrawal of a previously issued conclusion on the shortage. At the same time, it should be noted that the decision to revoke the previously issued conclusion and exclude the medicinal product from the list is made no earlier than 6 months from the date of the decision on the inventory shortage or its risk.
The order is valid till December 31, 2023.