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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

(as amended on 07-11-2023)

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. Determine that for action of threat of origin, origin and liquidation of emergency situation for the organization of delivery of health care to persons injured with emergency situations, preventions 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 features of conducting examination of quality of medicines and examination the relations of the expected advantage to possible risk of use of medicine for medical application can be established by the working group created under the Ministry of Health of the Russian Federation including in part:

reducings amount of such examinations when entering into documents of the registration file on the registered medicine of the changes connected with replacement, addition, exception of the production site of the producer of active pharmaceutical substance and ready dosage form, change of primary package;

possibilities of replacement of laboratory examinations with researches (testing) conducted concerning medicine for the purpose of its input in civil circulation according to article 52.1 of the Federal law "About Drug Circulation".

Provisions of this Item extend to cases of conducting the specified examinations according to the applications for state registration of medicines for medical application submitted in accordance with the established procedure to the Ministry of Health of the Russian Federation about day of entry into force of this resolution.

4. During action of the emergency situation provided in Item 3 of this resolution, submission of the documents and data specified in Articles 18 - 21, 23, 27 - 30, 32, 34, 38 - 40, 47, 61 and 62 Federal Laws "About Drug Circulation", and also in this resolution for the purposes of provision of the state services in the field of drug circulation for medical application, can be performed in the form of electronic document management without additional submission of the relevant documents and data on paper, including if necessary with assurance only by their applicant.

5. This resolution is effective till January 1, 2025.

Russian Prime Minister

M. Mishustin

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

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