ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of April 3, 2020 No. 441

About features of the address of medicines for medical application which are intended for application in the conditions of threat of origin, origin and liquidation of emergency situation and for the organization of delivery of health care to persons injured with emergency situations, the prevention of emergency situations, prevention and treatment of the diseases constituting danger to the people around, diseases and defeats received as a result of impact of adverse chemical, biological, radiation factors

The government of the Russian Federation decides:

1. Approve the enclosed features of the address of medicines for medical application which are intended for application in the conditions of threat of origin, origin and liquidation of emergency situation and for the organization of delivery of health care to persons injured with emergency situations, the prevention of emergency situations, prevention and treatment of the diseases constituting danger to the people around, diseases and defeats received as a result of impact of adverse chemical, biological, radiation factors.

2. Bring in Rules of maintaining the marginal state register of selling prices of producers on the medicines included in the list of vital and essential drugs, approved by the order of the Government of the Russian Federation of October 29, 2010 No. 865 "About state regulation of the prices of the medicines included in the list of vital and essential drugs" (The Russian Federation Code, 2010, No. 45, Art. 5851; 2018, No. 6597, Art. 43; 2019, No. 51, Art. 7649), following changes:

a) add Item 5 with the subitem "e (1)" the following content:

"e (1)) date and number of the order of the Ministry of Health of the Russian Federation on marginal establishment of selling price of the producer on medicine according to part 9 of article 61 of the Federal law "About Drug Circulation";";

b) to add Item 6 after the paragraph of the fourth with the paragraph of the following content:

"acceptances by the Ministry of Health of the Russian Federation decisions on marginal establishment of selling price of the producer on medicine according to part 9 of article 61 of the Federal law "About Drug Circulation".".

3. Ceased to be valid according to the Order of the Government of the Russian Federation of 21.12.2024 No. 1851

4. Ceased to be valid according to the Order of the Government of the Russian Federation of 21.12.2024 No. 1851

5. This resolution is effective till January 1, 2028.

Approved by the Order of the Government of the Russian Federation of April 3, 2020 No. 441

Features of the address of medicines for medical application which are intended for application in the conditions of threat of origin, origin and liquidation of emergency situation and for the organization of delivery of health care to persons injured with emergency situations, the prevention of emergency situations, prevention and treatment of the diseases constituting danger to the people around, diseases and defeats received as a result of impact of adverse chemical, biological, radiation factors

1. This document determines conditions of the address of medicines for medical application (further - medicines) which are intended for application in the conditions of threat of origin, origin and liquidation of emergency situation and for the organization of delivery of health care to persons injured with emergency situations, the prevention of emergency situations, prevention and treatment of the diseases constituting danger to the people around, diseases and defeats received as a result of impact of adverse chemical, biological, radiation factors (further - emergency situation).

2. State registration of medicines which are intended for application in the conditions of emergency situation (further - state registration of medicines) is performed by the Ministry of Health of the Russian Federation (further - the Ministry).

3. For state registration of medicine the legal entity acting to own advantage or authorized to represent the interests of other legal entity and declaring medicine on state registration, or the authorized representative of the applicant (further - the applicant) represents to the Ministry in the form of the electronic documents signed by the digital signature, the following documents and data:

a) the statement for state registration of medicine in which are specified:

the name, the address of the applicant and producer of medicine, data on their registration as the taxpayer in country of incorporation (for the Russian legal entities - the identification taxpayer number (ITN), for foreign legal entities - country of incorporation, the name of registering body, registration number, code of the taxpayer in country of incorporation (incorporation) or its analog) and the address of the place of implementation of production of medicine (in case of availability of several participants of process of its production it is necessary to specify each participant according to the performed production stage);

name of medicine (international unlicensed, either grouping, or chemical and trade names);

the list acting and the excipients which are part of medicine with indication of quantity of each of them;

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