On 5 July 2022 the State Duma approved in the third reading a draft law No. 11662-8 “On amendments to art. 6 of the Federal Law “On trade secrets” and art. 45 of the Federal Law “On medicines circulation”, under which the Ministry of Industry and Trade will be granted access to trade secrets of medicines ьmanufacturing.
According to the approved draft law, the Ministry of Health shall provide the Ministry of Industry and Trade with documents contained in the registration dossier on the manufacturing process and quality control of a medicine, even if such information constitutes a trade secret, upon its request. Such information shall be provided as part of the the inter-agency exchange. At the same time, the Ministry of Health shall notify the holder of trade secret on the scope of the revealed information.
In the explanatory note it is mentioned that provision of these documents is necessary for the purposes of licensing of the medicines manufacturing as well as inspecting of subjects of medicines circulation for compliance with the GMP rules within Eurasian Economic Union.