Specification of the information about the license is not required directly in the advertising of medical activities that are subject to licensing. Verification of the presence of relevant documents is carried out at the request of the advertising distributor in accordance with article 13 of the Law on advertising. The advertiser, in turn, shall provide reports, including information about the availability of a license, mandatory certification and state registration.

16 May 2020 the Russian Government enacted the rules on online sales and delivery of medicines (the Rules). According to the Rules, online sales of medicines are allowed. The exceptions are: RX medicines, narcotic and psychotropic medicines, and medicines containing more than 25% ethyl alcohol.

This refers to the fast track registration and conduct of clinical trials, which is valid until January 1, 2021 and is worked out for medical drugs potentially effective in the fight against COVID-19.

Federal law No 123-FZ sets a legal framework in Moscow for the development and implementation of artificial intelligence (AI) technologies. The experimental legal framework is established for five years starting from 1 July 2020.

The coronavirus outbreak (hereinafter referred to as “COVID-19”) served as a trigger for a targeted effort to assess and manage the possible effects of COVID-19.

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.