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. Ceased to be valid according to the Order of the Government of the Russian Federation of 08.04.2025 No. 462

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;

dosage form, dosage, methods of introduction and application, medicine expiration date;

pharmakoterapevtichesky group, code анатомо - the therapeutic and chemical classification recommended by the World Health Organization, the declared indications for use of medicine;

need of execution of the import permit to the Russian Federation specific batch of the registered and (or) unregistered medicines intended for conducting examination of medicines for the purpose of state registration;

data on payment of the state fee;

b) the copy of the document in Russian certified in accordance with the established procedure and confirming competence of the applicant to submit the application for state registration of medicine (power of attorney);

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