ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

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. Ceased to be valid according to the Order of the Government of the Russian Federation of 28.02.2025 No. 240

3. This resolution becomes effective from the date of its official publication and is effective till January 1, 2028.

Approved by the Order of the Government of the Russian Federation of April 1, 2022 No. 552

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

I. General provisions

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 register entry in the state register of medical products and the organizations (individual entrepreneurs) performing production and production of medical products (further respectively - the register entry, the state register), the state registration of which confirming the fact or in the statement for 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 the field of health care (further - registering body).

3. The fact of state registration of medical product according to this document is confirmed by the register entry in the state register.

State registration according to this document is effective till January 1, 2028.

4. The list of types of the medical products which are subject to the address according to this document (further - the list of medical products), affirms the interdepartmental commission which part representatives of the Ministry of Health of the Russian Federation, the Ministry of Industry and Trade of the Russian Federation, Ministry of Finance of the Russian Federation, the Ministry of Economic Development of the Russian Federation, Federal Antimonopoly Service, Federal Customs Service, Federal Tax Service, registering body, and also representatives of other bodies and organizations if necessary are (further - the interdepartmental commission).

Regulations on the interdepartmental commission, including procedure for the organization of its work, procedure for determination of items out of stock of medical products or risk of its origin, criteria of inclusion of medical products in the list of medical products and exception of it and structure of the interdepartmental commission affirm registering body in coordination with the Ministry of Health of the Russian Federation, the Ministry of Industry and Trade of the Russian Federation, the Ministry of Finance of the Russian Federation, the Ministry of Economic Development of the Russian Federation and Federal Antimonopoly Service.

Are included in the list of medical products:

medical products in case of availability of their items out of stock or risks of its origin;

medical products concerning which in the interdepartmental commission offers on delivery of medical products on the price below average market arrived;

other medical products determined by the interdepartmental commission.

The list of medical products is posted on the official site of registering body on the Internet (further - Internet network) in time, not exceeding 2 working days from the date of its approval (entering of changes into it) by the interdepartmental commission.

5. The following basic concepts are hereunder used:

"applicant" - the producer (manufacturer) of medical product, the authorized representative of the producer (manufacturer) or person performing import of medical product to the Russian Federation for the purpose of its state registration;

Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info