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.

The coronavirus outbreak (COVID-19) served as a trigger for a targeted effort to assess and manage the possible effects of it. The Russian Government continues to update the measures taken or introduce new ones, trying to act ahead of the possible adverse consequences. Our lawyers are closely monitoring the situation, watching out for the new measures introduced in relation to the coronavirus.
We offer overview of key legislative changes and recommendations for business in the current pandemic.

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.