of April 1, 2022 No. 552
About approval of features of the address, including features of state registration, medical products in case of their items out of stock or risk of emergence of items out of stock in connection with introduction concerning the Russian Federation of rationing arrangements of economic nature
According to part 5.1 of article 38 of the Federal law "About Bases of Protection of Public Health in the Russian Federation", Item 3 of part 1 of article 18 of the Federal Law of March 8, 2022 "About modification of separate legal acts of the Russian Federation" the Government of the Russian Federation decides No. 46-FZ:
1. Approve the enclosed features of the address, including features of state registration, medical products in case of their items out of stock or risk of emergence of items out of stock in connection with introduction concerning the Russian Federation of rationing arrangements of economic nature.
2. Examination of the statement for state registration of medical product and the documents submitted according to the Rules of state registration of medical products approved by the order of the Government of the Russian Federation of December 27, 2012 No. 1416 "About approval of Rules of state registration of medical products" from the date of entry into force of this resolution is performed along with conducting examination of completeness and results of the conducted technical testing of toxicological researches, clinical testing, and also testing for the purpose of approval like measuring instruments (concerning the medical products relating to measuring instruments in the sphere of state regulation of ensuring unity of measurements which list affirms the Ministry of Health of the Russian Federation), except for the researches requiring carrying out clinical testing with participation of the person.
Russian Prime Minister
Approved by the Order of the Government of the Russian Federation of April 1, 2022 No. 552
1. This document in connection with introduction concerning the Russian Federation of rationing arrangements of economic nature determines features of the address of medical products, including features of state registration of medical products, modification of the documents containing in the registration file on medical product of national production (medical product, in the registration certificate or in the statement about which state registration as the producer (manufacturer) it is specified the legal entity or physical person registered as the individual entrepreneur, who are residents of the Russian Federation, and also taking production site (production site) in the territory of the Russian Federation (further - medical product of national production).
2. State registration of medical products according to this document is performed by the Federal Service on supervision in health sector (further - registering body).
3. The fact of state registration of medical product according to this document is confirmed by the registration certificate on medical product which is issued valid through January 1, 2025, and the register entry in the state register of medical products and the organizations (individual entrepreneurs) performing production and production of medical products (further - the state register).
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