the Law “On amendments to certain legislative acts of the Russian Federation on issues of providing citizens with medicines, medical products and specialized nutritional”, in particular, gives the Cabinet the right to set a delay on the introduction of compulsory labeling for some drugs from 3 to 6 months.
the Government has the right to establish features of the input into civil circulation of medicinal products produced during the period from July 1, 2020 October 1, 2020 (with the exception of drugs intended for the treatment of 7 high-cost nosologies), and which can be imported into Russia until the end of 2020 without any means of identification.
As previously reported, from 1 July 2020 in Russia should be prohibited the circulation of drugs without digital codes in the system “Honest sign”.
the Document also envisages the creation of a Federal registry of citizens eligible for providing drugs, medical products and specialized nutritional at the expense of means of the Federal budget and budgets of subjects of the Russian Federation.
in Addition to information on the number of insured persons and categories of diseases in the Federal register shall be relevant, factual information on the availability of each beneficiary drugs. To maintain a register in accordance with the law is the Ministry of health. Regional segments of the Federal register are required to complete and control the bodies of state power of regions.
the Basis of the Federal register will be the information from the social register and the unified state information system of social security (EGIS).
Set the frequency of the revision of the list of vital and essential medicinal products – at least once a year.
the law Also harmonizes national legislation with the law of the Eurasian economic Union in terms of registration and circulation on the territory of the Russian Federation of medical products. Registration will not be subject to the medical product, the registration of which is not provided in the framework of the Eurasian economic Union.