ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of May 8, 2025 No. 609

About introduction of amendments to some acts of the Government of the Russian Federation

The government of the Russian Federation decides:

1. Approve the enclosed changes which are made to the Regulations on licensing of medical activities (except for the specified activities performed by the medical organizations and other organizations entering private health care system, in the territory of the innovative center "Skolkovo") approved by the order of the Government of the Russian Federation of June 1, 2021 No. 852 "About licensing of medical activities (except for the specified activities performed by the medical organizations and other organizations entering private health care system, in the territory of the innovative center "Skolkovo") and recognition voided some acts of the Government of the Russian Federation" (The Russian Federation Code, 2021, No. 23, Art. 4091; 2022, No. 8, Art. 1187; 2024, No. 13, Art. 1803).

2. Recognize to invalid:

the subitem "d" of Item of 2 changes which are made to the order of the Government of the Russian Federation of June 1, 2021 No. 852, approved by the order of the Government of the Russian Federation of February 16, 2022 No. 181 "About modification of the order of the Government of the Russian Federation of June 1, 2021 No. 852" (The Russian Federation Code, 2022, No. 8, the Art. 1187);

item 4 of changes which are made to Regulations on licensing of medical activities (except for the specified activities performed by the medical organizations and other organizations entering private health care system, in the territory of the innovative center "Skolkovo"), approved by the order of the Government of the Russian Federation of March 20, 2024 No. 334 "About modification of the order of the Government of the Russian Federation of June 1, 2021 No. 852" (The Russian Federation Code, 2024, No. 13, the Art. 1803).

3. This resolution becomes effective from the date of its official publication.

Approved by the Order of the Government of the Russian Federation of May 8, 2025 No. 609

Changes which are made to Regulations on licensing of medical activities (except for the specified activities performed by the medical organizations and other organizations entering private health care system in the territory of the innovative center "Skolkovo")

1. State Item 8 in the following edition:

"8. For receipt of the license the license applicant directs to the licensing body the application for provision of the license in electronic form by filling of the interactive application form about provision of the license, including with use of data from the federal state information system "Single System of Identification and Authentication in the Infrastructure Providing Information and Technological Interaction of the Information Systems Used for Provision of the State and Municipal Services Electronically", in personal account of the federal state information system "Single Portal of the State and Municipal Services (Functions)" in which the data provided by part 1 of article 13 of the Federal law "About Licensing of Separate Types of Activity" and also the data confirming compliance of the license applicant to licensed requirements are specified including:

number and date of issue of the sanitary and epidemiologic conclusion about compliance to health regulations of the buildings, structures, constructions and (or) rooms necessary for accomplishment by the license applicant of the declared works (services);

surnames, names, middle names (in the presence), insurance numbers of individual personal accounts (in the presence) the workers who signed employment contracts with the license applicant specified in the subitem "v" of Item 5 of this provision.

In case of filing of application about provision of the license, statement for modification of the register of licenses by the legal entity, individual entrepreneur signing of such statement according to the Federal Law "About Licensing of Separate Types of Activity" the strengthened qualified digital signature of the head of permanent executive body of the legal entity or other having right to act on behalf of this legal entity without power of attorney of person or the individual entrepreneur is performed.

In case of filing of application about provision of the license, statement for modification of the register of licenses by the physical person representing the interests of the legal entity or individual entrepreneur by proxy (in the presence electronically in machine-readable type of the powers of attorney confirming appropriate authority), signing of such statement is performed by the strengthened qualified digital signature or the strengthened unqualified digital signature which certificate of key of check is created and used in the infrastructure providing information and technological interaction of the information systems used for provision of the state and municipal services and execution of the state and municipal functions electronically in the procedure established by the Government of the Russian Federation, the specified person.".

2. Item 8 (to declare 1) invalid.

3. State Item 10 in the following edition:

"10. In time, not exceeding 10 working days from the date of reception of an application about provision of the license (except as specified, specified in the paragraph the second this Item), the licensing body performs check of completeness and reliability containing in the specified statement of data, including assessment of conformity of the license applicant to licensed requirements, and makes the decision on provision of the license or on refusal in its provision.

In case of intention of the license applicant to perform medical activities in the territory of the closed administrative-territorial education the term of implementation of check of completeness and reliability containing in the specified statement of data, including assessments of conformity of the license applicant to licensed requirements, and decision making about provision of the license or about refusal in its provision is not exceeded by 15 working days from the date of reception of an application about provision of the license.".

4. In Item 11:

a) the paragraph one to state in the following edition:

"11. In case of intention of the licensee to perform medical activities for the address which is not specified in the register of licenses and (or) to perform the works (services) constituting medical activities, which are not provided by the register of licenses, the licensee directs to the application for modification of the register of licenses licensing body in electronic form by filling of the interactive application form about modification of the register of licenses, including with use of data from the federal state information system "Single System of Identification and Authentication in the Infrastructure Providing Information and Technological Interaction of the Information Systems Used for Provision of the State and Municipal Services Electronically", in personal account of the federal state information system "Single Portal of the State and Municipal Services (Functions)" in which are specified this address and (or) works (service), which the licensee intends to carry out, and also the data confirming compliance of the licensee to licensed requirements including:

number and date of issue of the sanitary and epidemiologic conclusion about compliance to health regulations of the buildings, structures, constructions and (or) rooms necessary for accomplishment by the licensee of the declared works (services);

surnames, names, middle names (in the presence), insurance numbers of individual personal accounts (in the presence) the workers who signed employment contracts with the licensee specified in the subitem "v" of Item 5 of this provision concerning the address to which the licensee intends to perform medical activities, and (or) works (services) which the licensee intends to carry out.";

b) third to state the paragraph in following edition:

"The licensing body performs check of completeness and reliability containing in the application of data submitted according to this Item, including assessment of conformity of the licensee to licensed requirements, and makes the decision on modification of the register of licenses or on refusal in modification of the register of licenses in time which is not exceeding 5 working days from the date of obtaining by the licensing body of the statement for modification of the register of licenses if 1 address which is not specified in the register of licenses, and no more than 10 works (services) which the licensee intends to carry out in out-patient conditions according to the qualifier of works (services) constituting medical activities, the approved Ministry of Health of the Russian Federation is specified in the statement for modification of the register of licenses.";

c) add with paragraphs of the following content:

"In the cases which are not specified in paragraph five of this Item, the licensing body performs check of completeness and reliability containing in the application of data submitted according to this Item, including assessment of conformity of the licensee to licensed requirements, and makes the decision on modification of the register of licenses or on refusal in modification of the register of licenses in time which is not exceeding 10 working days from the date of obtaining by the licensing body of the statement for modification of the register of licenses, and when implementing medical activities in the territory of the closed administrative-territorial education - in time, the licensing body of the statement for modification of the register of licenses which is not exceeding 15 working days from the date of obtaining.

The licensing body makes the decision on cancellation of the license in time, not exceeding 3 working days from the date of receipt of the statement of the licensee for the termination of medical activities.".

5. Declare Item 12 invalid.

6. In Item 18 of the word "the documents necessary for receipt of the license, and their acceptance by the licensing body," to exclude.

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