Постановление Правительства РФ от 21 декабря 2024 г. № 1851

About making amendments to certain Acts of the Government of the Russian Federation 

         The Government of the Russian Federation decides:

1. Approve the attached amendments to the acts of the Government of the Russian Federation.

2. Establish that:

registration certificates for a series (batch) of a medical device intended for use in military operations, emergencies, prevention of emergencies, prevention and treatment of diseases that pose a danger to others, diseases and lesions resulting from exposure to adverse chemical, biological, radiation factors, according to the list in accordance with Appendix No. 1 to the Special Requirements of the Russian Federation. applications for medical devices, including state registration of a series (batch) of a medical device, approved by Decree of the Government of the Russian Federation No. 430 of April 3, 2020 "On the specifics of circulation of medical devices, including state registration of a series (batch) of a Medical device", issued in accordance with the said resolution before the date of entry into force of this Law. resolutions that are valid until January 1, 2025, are valid until January 1, 2028 without replacement.

registration certificates of medicinal products for medical use valid until January 1, 2025, issued in accordance with the Decree of the Government of the Russian Federation No. 441 of April 3, 2020 "On the specifics of circulation of medicinal products for medical use that are intended for use in conditions of threat of occurrence, occurrence and elimination of an emergency situation and for organizing the provision of medical assistance to persons affected by emergencies, prevention of emergencies, prevention and treatment of diseases that pose a danger to others, diseases and injuries resulting from exposure to adverse chemical, biological, and radiation factors" (hereinafter referred to as Decree of the Government of the Russian Federation No. 441 of April 3, 2020) until the date of entry into force of this Law. regulations that are valid until January 1, 2028 without replacement.

permits for the temporary circulation of a series (batch) of a medicinal product not registered in the Russian Federation and permitted for medical use in the territories of foreign states by the authorized bodies of the relevant foreign states, issued in accordance with Decree of the Government of the Russian Federation No. 441 of April 3, 2020 prior to the date of entry into force of this resolution, are valid until January 1, 2028. and пункте 25are subject to replacement at the request of a legal entity acting in its own interests or authorized to represent the interests of another legal entity in whose name the relevant permit has been issued, submitted to the Ministry of Health of the Russian Federation, with the Ministry of Health of the Russian Federation making appropriate changes to the register specified in paragraph 25 of the application in the conditions of threat of occurrence, occurrence and liquidation of an emergency situation and for the organization of medical care to persons affected by emergency situations, prevention of emergency situations, prevention and treatment of diseases that pose a danger to others, diseases and lesions resulting from exposure to adverse chemical, biological, radiation factors approved by the decree of the Government of the Russian Federation dated April 3, 2020 N 441;

decisions on state registration of maximum selling prices of manufacturers for medicinal products included in the list of vital and essential medicinal products adopted in accordance with Decree of the Government of the Russian Federation No. 441 of April 3, 2020, which expire before January 1, 2025, are valid until January 1, 2028;

registration certificates for medical devices valid until January 1, 2025, issued in accordance with the Decree of the Government of the Russian Federation No. 552 of April 1, 2022 " On approval of the Specifics of circulation, including the Specifics of State Registration, of Medical devices in case of their Defect or the risk of defect in connection with the introduction of restrictive Measures against the Russian Federation of an economic nature" until the date of entry into force of this resolution, valid until January 1, 2028 without replacement;

registration certificates of medicinal products for medical use valid until December 31, 2024, issued in accordance with Decree of the Government of the Russian Federation No. 593 of April 5, 2022 "On the specifics of circulation of Medicinal Products for medical use in the Event of Defects or the risk of defects in medicinal products in connection with the introduction of Restrictive Economic Measures against the Russian Federation". nature" (Hereinafter-Resolution of the Government of the Russian Federation No. 593 of April 5, 2022) until the date of entry into force of this resolution, valid until December 31, 2027 without replacement;

permits for the temporary circulation of a series (batch) of a medicinal product not registered in the Russian Federation, having analogues registered in the Russian Federation under an international nonproprietary name and permitted for medical use in the territories of foreign states by authorized bodies of the relevant foreign states, issued in accordance with Decree of the Government of the Russian Federation No. 593 of April 5, 2022, prior to the date of entry into force of the Law of the Russian Federation. effective until December 31, 2027 and are subject to replacement at the request of a legal entity acting in its own interests or authorized to represent the interests of another legal entity in whose name the relevant permit has been issued, submitted to the Ministry of Health of the Russian Federation, with the relevant changes made by the Ministry of Health of the Russian Federation to the register of issued permits for temporary treatment in case of a defect or the risk of a defect.

3. To the Ministry of Health of the Russian Federation:

until December 27, 2024, in accordance with paragraph five of paragraph 2 of this resolution, make changes to orders on state registration of maximum selling prices of manufacturers for medicines included in the list of vital and essential medicines (the Ministry of Health of the Russian Federation sends relevant extracts to the owners (holders) of registration certificates of such medicines (persons authorized by them)  from the specified orders) and in the register entries of the state register of maximum selling prices of manufacturers for medicines included in the list of vital and essential medicines;

until January 1, 2025, enter in the state register of medicinal products for medical use information on changes in the validity period of registration certificates specified in paragraphs three and seven of paragraph 2 of this resolution.

4. By January 1, 2025, the Federal Service for Healthcare Supervision should enter into the state register of medical devices and organizations (individual entrepreneurs) engaged in the production and manufacture of medical devices information on changes in the validity period of the registration certificates specified in paragraphs two and six of paragraph 2 of this resolution.

5. The thirty-second paragraph of sub item "b" of item 2 of the amendments to the acts of the Government of the Russian Federation approved by the Decree of the Government of the Russian Federation No. 2056 of November 14, 2022 "On Amendments to Certain Acts of the Government of the Russian Federation" (Collection of Legislation of the Russian Federation, 2022, No. 47, Article 8219) should be recognized expired.

6. This resolution comes into force from the date of its official publication.

Chairman of the Government

Of the Russian Federation

M. MISHUSTIN

APPROVED

by Government Resolution

Of the Russian Federation

dated December 21, 2024 N 1851

 

 

THE AMENDMENTS

WHICH ARE INCLUDED IN ACTS OF THE GOVERNMENT

OF THE RUSSIAN FEDERATION

 

1. In Resolution of the Government of the Russian Federation No. 430 of April 3, 2020 "On the specifics of circulation of medical Devices, including State Registration of a Series (Batch) of Medical Devices" (Collection of Legislation of the Russian Federation, 2020, No. 15, Article 2284; No. 23, Article 3667; No. 47, Article 7530; 2021, No. 11, Article 1829; No. 51, Article 8839):

a) in paragraph 2, replace the words "January 1, 2025" with the words "January 1, 2028";

b) in the specifics of circulation of medical products, including state registration of a series (batch) of medical products approved by the said resolution:

in paragraph 2, replace the words "January 1, 2025" with the words "January 1, 2028";

in point 10:

in the fourth paragraph, replace the words "January 1, 2025" with the words "January 1, 2028";

in the fifth paragraph, replace the words "January 1, 2025" with the words "January 1, 2028".

2. In Resolution of the Government of the Russian Federation No. 441 of April 3, 2020 "On the specifics of circulation of Medicinal products for medical use that are intended for use in conditions of threat of occurrence, occurrence and elimination of an Emergency Situation and for organizing the provision of medical care to persons affected by Emergencies, prevention of Emergencies, prevention and treatment of diseases and injuries resulting from exposure to adverse chemical, biological, or radiation factors " (Collection of Legislation of the Russian Federation, 2020, No. 15, Article 2295; No. 37, Article 5711; No. 48, Article 7718; 2021, No. 47, Article 7864; 2023, No. 1 335; No. 46, Article 8262):

a) declare paragraphs 3 and 4 invalid;

b) in paragraph 5, replace the words "until January 1, 2025" with the words "until January 1, 2028";

c) in the specifics of the circulation of medicinal products for medical use, which are intended for use in conditions of threat of occurrence, occurrence and elimination of an emergency situation and for organizing the provision of medical care to persons affected by emergency situations, prevention of emergency situations, prevention and treatment of diseases that pose a danger to others, diseases and lesions resulting from effects of adverse chemical, biological, and radiation factors approved by the said resolution:

in the third paragraph of paragraph 14, replace the words "until January 1, 2025" with the words "until January 1, 2028";

in paragraph 17(2), replace the words "December 1, 2024" with the words "December 1, 2027";

in subparagraph "b" of paragraph 17(12), replace the words "December 31, 2025" with the words "January 1, 2028";

in paragraph 18, replace the words "until January 1, 2025" with the words "until January 1, 2028".

3. In paragraph 2 of the Decree of the Government of the Russian Federation No. 440 of March 23, 2022 "On Approval of the Specifics of Making Changes to the Documents Contained in the Registration Dossier for a Registered Medicinal Product for Medical Use in the Event of a Defect or Risk of a Defect in Medicinal Products due to the Introduction of Restrictive Economic Measures against the Russian Federation" (Collection of Legislation of the Russian Federation, 2022, No. 13, Article 2101; No. 47, Article 8219; 2023, No. 39, Article 7037) replace the words "until December 31, 2024" with the words "until December 31, 2027".

4. In Resolution of the Government of the Russian Federation No. 552 of April 1, 2022 "On Approval of the Specifics of Circulation, including the Specifics of State Registration, of Medical Devices in the Event of their Defect or the Risk of Defect in connection with the Introduction of Restrictive Economic measures against the Russian Federation" (Collection of Legislation of the Russian Federation, 2022, No. 15, art. 2473; N 40, article 6806):

a) in paragraph 3, replace the words "until January 1, 2025" with the words "until January 1, 2028";

b) in the first paragraph of paragraph 3 of the specifics of circulation, including the specifics of state registration, of medical devices in the event of their defect or the risk of a defect in connection with the introduction of restrictive economic measures against the Russian Federation approved by the said resolution, replace the words "until January 1, 2025" with the words "until January 1, 2028".

5. In Resolution of the Government of the Russian Federation No. 593 of April 5, 2022 "On the specifics of circulation of Medicinal Products for medical Use in the event of Defects or the risk of defects in Medicinal Products in connection with the introduction of restrictive economic measures against the Russian Federation" (Collection of Legislation of the Russian Federation, 2022, No. 16, Article 2657; N 47, Article 8219; 2023, N 24, Article 4312):

a) in paragraph 3, replace the words "until December 31, 2024" with the words "until December 31, 2027";

b) in the specifics of the circulation of medicinal products for medical use in the event of a defect or the risk of a defect in medicinal products in connection with the introduction of restrictive economic measures against the Russian Federation approved by the said resolution:

in the third paragraph of paragraph 18, replace the words "December 31, 2024" with the words "December 31, 2027";

in the first paragraph of paragraph 22, replace the words "December 31, 2024" with the words "December 31, 2027";

declare paragraph 34 as invalid;

in paragraph 51, replace the words "December 1, 2024" with the words "December 1, 2027";

in subparagraph "b" of paragraph 60, replace the words "December 31, 2025" with the words "December 31, 2027".