Circulation of Medical Products and Medical Devices in Russia: Changes in Regulation

On March 26, 2022, the Federal Law No. 64-FZ “On Amendments to Certain Legislative Acts of the Russian Federation” was adopted (“Law”). It provides for the establishment of certain features of the circulation of medical products (“MP”) and medical devices (“MD”) in Russia in connection with the current economic situation. Such features include the following.

1. Import and circulation of MP in the territory of the Russian Federation

The Law allows the usage, import and circulation of the MP for medical in the territory of the Russian Federation in packages intended for circulation in other countries until December 31, 2022. This provision is implemented in order to avoid the possible defect of MP or the risk of its occurrence in connection with the introduction of restrictive economic measures against the Russian Federation.

For the purpose of import and circulation of designated MP, it will be sufficient to comply with the following requirement – to have a self-adhesive label with information about MP in Russian. However, neither the Law nor the provisions of current legislation contains information about what kind of data should be reflected on the label.

At the same time, the question of compliance with the requirements for labeling MP with Data Matrix codes is pending, since these amendments do not contain information about whether such a code will be applied to a self-adhesive label and, if so, who will in charge of that.

It is also noteworthy that the import and circulation of these MP will be carried out taking into account the specifics that will be determined by the Government of the Russian Federation. However, the issue of certain specifics to be established by the Government of the Russian Federation also remains unresolved.

Other requirements for the import and circulation procedures of MP in the territory of the Russian Federation, including Article 52.1 of Federal Law No. 61-FZ of April 12, 2010 “On the Circulation of Medicinal Products”² (“Law on the Circulation of MP”), remain in force.

2. Supply of MP by manufacturers and distributors

The Law provides for certain restrictions affecting the commercial activities of manufacturers and distributors of MP. The specified parties:

• will have to comply with the deadlines for the shipment of MP requested by the pharmacy organization, while such deadlines will be separately established by the authorized federal executive body;
• will not have the right to refuse to supply MP to a pharmacy organization with which there is a relevant contract if such MP is available from the relevant manufacturer or distributor.

These provisions raise a number of queries, including the correlation of these restrictions with, for example, the right prescribed in the relevant supply contract to refuse delivery until the pharmacy repays overdue debts, or the terms of the commercial policy of the manufacturer or distributor. In practice, it is not feasible to avoid situations where manufacturers or distributors have to choose which of the counterparties to supply the remaining MP, and whom to refuse if the supply requests were received at the same time, or it will be necessary to “divide” these balances between the pharmacy organizations.

3. Notification to Roszdravnadzor on suspension or termination of manufacturing or supply of MD

In terms of regulating the circulation of MD, changes have been made to the requirements for notifying Roszdravnadzor of the suspension or termination of their manufacturing or supply to the territory of the Russian Federation. So, the deadline for submitting such a notification is fixed at the level of at least 6 months.

At the same time, the form of the specified notification is not legally established, as well as the information to be reflected in it. In this regard, the notification on suspension or termination of the manufacturing or supply of MID as a similar notification with respect to MP, is submitted in a free form. As Roszdravnadzor indicated in its explanations regarding MP, the reasons for such suspension and termination are determined by the companies themselves and do not require any coordination with regulatory authorities⁴ .

For failure to provide such notification to Roszdravnadzor, administrative liability is provided in the form of a fine: from 10 to 15 thousand rubles for officials; from 30 to 70 thousand rubles for legal entities⁴ .

4. Public procurement of MP and MD

The Law also provides for changes in the regulation of public procurement for 2022 and 2023. Thus, the calculation of the total annual volume of purchases will not include the purchase of MP for medical use and MD.

These provisions of the Law come into force from the date of its adoption, but their impact on economic relations will be possible to assess only after their practical application.