According to art. 38 of the Law on fundamental healthcare principles the software used for medical purposes has a legal status of medical device. Therefore, market turnover of such software in Russia is allowed only after software is registered before the Federal Service for Surveillance in Healthcare (Roszdravnadzor).

On March 3, 2020, the Russian Government introduced to the State Duma the Draft Law on amendments to the Russian Civil Code, namely, article 1360.1.

On 1st January 2020, the Federal Law of 02.08.2019 № 265-FZ “On Amendments to the Federal Law” “On Currency Regulation and Currency Control” entered into force in terms of liberalization of restrictions on foreign exchange transactions that are made by residents using accounts (deposits) opened with banks located outside the territory of the Russian Federation and repatriation of funds.

At the end of 2019, Federal Law No. 405-FZ entered into force. This act has significantly increased administrative liability for violations of the requirements on the localization of databases containing personal data of Russian nationals. We already wrote about this amendment earlier.

The year 2019, which continued the trend of rapid and numerous changes in healthcare regulations, was rich on expectations, events and legislative proposals aiming to reverse pharmaceutical industry: medical drugs labeling, reform of price determination, new procedure of entry into drugs civil circulation, amendments to regulatory framework of the Eurasian Economic Union, etc. This trend is likely to continue in 2020 as well.

According to Chapter 57 of the Federal law No. 289-FZ dated 03.08.2018 “On Customs Regulation in the Russian Federation and on amending certain legislative acts of the Russian Federation” (Law on customs regulation) a rightholder is entitled to file to the Customs Service an application for including their IP objects to the Customs Register seeking rights protection.

On December 25, 2019 the Presidium of the Supreme Court of the Russian Federation adopted the Judicial Review on certain issues arising in the application of law on business companies.

On July 9, 2019 the Plenum of the Supreme Court of the Russian Federation approved the Resolution. № 4 “On the application of private international law by the courts of the Russian Federation” (hereinafter — the Resolution).

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.