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.

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.

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.

In September the draft law was amended with a new provision on the creation of Register of pharmacologically active substances. Under this provision, Rospatent will keep the publicly available Register of pharmacologically active substances protected by patent.

Under the Federal Law “On drugs circulation” (Law), information on state registration of drugs in Russia shall be publicly available.

On December 13, 2018 Russian State Duma has passed in the third reading a draft law empowering the state healthcare control (supervision) body (Roszdravnadzor) to conduct test purchases (“Draft law”).

On November 28, 2018 the Federal law of November 28, 2018 No. 449-FZ “On amendments being made to separate legal acts regarding introduction of drugs into commercial turnover” (the “Law”) was published on the official web portal of legal information.

On October 18, 2018 new wording of the Rules of state registration and re-registration of maximum sale prices established by drug manufacturers for those drugs, that are included in the vital and essential drugs list (“the Rules” and “the Drugs” correspondingly) has been enacted with the amendments introduced by the Russian Government Decree of 08.10.2018 No. 1207 “On amendments to the Russian Government Decree of October, 29 2010 No. 865 and of September, 15 2015 No. 979” (“the Decree”).