New rules for medical devices registration in Eurasian Union
Eurasian Economic Commission adoptedRecommendations No. 15 “On amendments to Rules for medical devices registration in Eurasian economic union on 29 June 2021.
Eurasian Economic Commission adoptedRecommendations No. 15 “On amendments to Rules for medical devices registration in Eurasian economic union on 29 June 2021.
In a Resolution dated May 25, 2021, when examining the complaint of MedReyting LLC, the Constitutional Court of the Russian Federation clarified the procedure for applying para. 8, part 1, art. 6 of the Federal Law "On Personal Data", according to which the processing of personal data is necessary for the professional activity of a journalist and (or) the legitimate activity of the mass media or scientific, literary or other creative activities, provided that the rights and legitimate interests of the subject of personal data are not violated.
Foundation for support of children with severe life-threatening and chronic diseases, including rare (orphan) diseases (“Circle of Good” or “Fund”) was established by the decree of the President of the Russian Federation in 2021.
On March, 2021 the US Department of Commerce has imposed sanctions on Russian suppliers of medical devices and equipment due to suspicion of developing chemical weapons.
The Ministry of Healthcare of the Russian Federation approved the "Procedure for monitoring the safety of medical devices" (hereinafter referred to as the "Procedure"), which will come into force on January 1, 2021, and will be valid until January 1, 2027.
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.
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