Practices
Industries

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

28 March 2022

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.

New Legal Requirements: Government Amendments

05 March 2022

On March 04, 2022, the Council of Federation has approved and sent to the President the Federal Law “On Amending Certain Legislative Regulations of the Russian Federation” (the “Law”). This Law provides for a number of changes in the regulation of procurement and circulation of medical products (“MP”) and medical devices (“MD”), corporate and financial relations, and even social matters.

Track and trace for Medicines. Amendments 2019

27 December 2019

Under the Decree of the Government of the Russian Federation No. 1556 dated December 14, 2018 (hereinafter — Decree No. 1556), monitoring system of the medical drugs circulation should become effective from the January 2020 with the exception of medical drugs for healing high-cost ICD diseases, which have already been monitored from October1, 2019.