Press Center: Legal updates

From 1 January 2022, the registration of medical devices will proceed only under the Eurasian Economic Union rules.

The Draft Law № 912458-7 “On amendments to the part four of the Russian Civil Code” has passed through the third reading in the State Duma on 25 May 2021. The Draft Law implements article 1360.1 to part four of the Russian Civil Code.

The draft law “On amendments to Federal Law “On drugs circulation” had been already amended with a provision on the creation of a unified Register of pharmacologically active substances in 2019.

The Russian President approved Law No. 107-FZ “On amendments to art. 1360 of the 4^th part of the Russian Civil Code”(“Law”) on 30 April 2021.

Since 1 March 2021, the Pharmaceutical Register of the Eurasian Patent Office (EAPO) is available on the official website of the Eurasian Patent Office. The Register contains information on Eurasian patents protecting active substances of drugs.

On January 5, 2021 the Decree of the Government of the Russian Federation No. 3718-r dated December 31, 2020 (the Decree) was published. In accordance with the Decree, Pharmasintez JSC, a Russian generic company, has been granted a 1-year compulsory license to use the inventions of the US companies Gilead Sciences Inc. and Gilead Pharmasset LLC protecting Remdesivir subject to a “fair compensation”¹.

A new procedure on medical devices import for their further registration in Russia¹ will enter into force from 1 January 2021.

18 September 2020 the Russian Federal Antimonopoly Service (the FAS) published the full decisions on cases No. 1-14-163/00-08-18 and 1-14-164\00-08-18. According to the decisions, Daimler AG and KYB Corporation breached art. 14.8 of the Russian Antitrust law by committing acts of unfair competition.

The new rules on the medicines interchangeability No. 1360 (hereinafter – the Rules) enacted by the Russian Government have entered into force on 9 September 2020.