THE ORDER OF THE MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION AND THE FEDERAL SERVICE OF THE RUSSIAN FEDERATION ON SUPERVISION IN THE FIELD OF HEALTH CARE

of October 28, 2020 No. 9936

About approval of Administrative regulations of the Federal Service on supervision in the field of health care on provision of the state service in 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")

According to the Federal Law of July 27, 2010 No. 210-FZ "About the organization of provision of the state and municipal services" (The Russian Federation Code, 2010, No. 31, Art. 4179; 2020, No. 31, the Art. 5027), the order of the Government of the Russian Federation of May 16, 2011 No. 373 "About development and approval of administrative regulations of implementation of the state control (supervision) and administrative regulations of provision of the state services" (The Russian Federation Code, 2011, No. 22, Art. 3169; 2018, No. 46, the Art. 7050) and the subitem "an" of Item 2 of 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 April 16, 2012 No. 291 (The Russian Federation Code, 2012, No. 17, Art. 1965; 2020, to No. 32, of the Art. 5299), I order:

1. Approve the enclosed Administrative regulations of the Federal Service on supervision in the field of health care on provision of the state service in 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").

2. This order becomes effective since January 1, 2021.

Approved by the Order of the Federal Service of the Russian Federation on supervision in the field of health care of October 28, 2020, No. 9936

Administrative regulations of the Federal Service on supervision in the field of health care on provision of the state service in 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")

I. General provisions

Subject of regulation of Administrative regulations

1. The administrative regulations of the Federal Service on supervision in the field of health care on provision of the state service in 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") (further respectively - Administrative regulations, the state service, medical activities) establish terms and the sequence of ministerial procedures (actions) of the Federal Service for supervision in the field of health care, order of interaction between structural divisions of Roszdravnadzor, territorial authorities of Roszdravnadzor (further - territorial authorities), their officials, and also interactions of Roszdravnadzor (territorial authorities) with applicants, other public authorities and local government bodies, the organizations by provision of the state service.

Circle of applicants

2. Applicants on provision of the state service (further - applicants) are:

1) the legal entities having intention to perform or performing medical activities or their authorized representatives;

2) the physical persons and the organizations which addressed for provision of data on the specific license for implementation of medical activities and other information on provision of the state service.

Requirements to procedure for informing on provision of the state service

3. Informing on procedure for provision of the state service is performed:

on the official site of Roszdravnadzor (territorial authorities) on the Internet (further respectively - the official site of Roszdravnadzor (territorial authority), Internet network);

in the federal state information system "Single Portal of the State and Municipal Services (Functions)" (further - the Single portal);

in the federal state information system "Federal Register of the State Services (Functions)" (further - the federal register);

at information stands in reception on work with addresses of citizens of Roszdravnadzor (territorial authorities);

on phone numbers for reference.

4. Reference information concerning provision of the state service is placed:

on the official site of Roszdravnadzor (territorial authorities);

on the Single portal;

in the federal register;

at information stands in reception on work with addresses of citizens of Roszdravnadzor (territorial authorities).

5. Reference information is provided by the officials of Roszdravnadzor (territorial authorities) responsible for provision of the state service, by phone, on personal acceptance of the applicant or in writing the mailing or the electronic message to the address specified by the applicant.

Reference information includes data on the location, the working schedule, telephone numbers for enquiries, number of phone informant, on addresses of the official site of Roszdravnadzor (territorial authority), e-mail and (or) feedback forms with Roszdravnadzor (territorial authorities).

6. On the official site of Roszdravnadzor (territorial authorities), information stands in reception on work with addresses of citizens of Roszdravnadzor (territorial authorities), on the Single portal the following information is placed:

procedure for receipt of information by applicants concerning provision of the state service;

data on the course of provision of the state service;

the list of the regulatory legal acts of the Russian Federation regulating provision of the state service;

text of Administrative regulations;

the forms of statements (notifications, messages) used by service provision.

7. Information on the Single portal and the official site of Roszdravnadzor (territorial authorities) on procedure and terms of provision of the state service based on the data containing in the federal register is provided to the applicant on a grant basis.

II. Standard of provision of the state service

Name of the state service

8. The state service in 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").

The name of the federal executive body providing the state service

9. The state service is provided by Roszdravnadzor and its territorial authorities.

10. It is forbidden to demand from the applicant of implementation of actions the, including approvals necessary for receipt of the state service and connected with the appeal to other state bodies and the organizations, except for receipts of the services included in the list of services approved by the Government of the Russian Federation <1>.

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<1> The order of the Government of the Russian Federation of May 6, 2011 "About approval of the list of services which are federal executive bodies, State Atomic Energy Corporation "Rosatom" of the state services, necessary and obligatory for provision, and it are provided to No. 352 by the organizations participating in provision of the state services, and determination of the amount of payment for their rendering" (The Russian Federation Code, 2011, No. 20, Art. 2829; 2020, No. 39, the Art. 6038) (further - the List of services).

Description of result of provision of the state service

11. Results of provision of the state service are:

1) provision (refusal in provision) licenses;

2) renewal (refusal in renewal) licenses;

3) provision of data from the register of licenses;

4) cancellation of the license according to the statement of the licensee.

The term of provision of the state service, including taking into account need of the appeal to the organizations participating in provision of the state service, the term of suspension of provision of the state service if the possibility of suspension is stipulated by the legislation the Russian Federation, the term of issue (direction) of the documents which are result of provision of the state service

12. The term of provision of the state service and issue (direction) of the documents which are result of provision of the state service:

1) decision making about provision (about refusal in provision) licenses - no more than 45 working days from the date of receipt in Roszdravnadzor (territorial authority) of properly issued application for provision of the license and documents (data), stipulated in Item 15 Administrative regulations;

2) decision making about renewal (about refusal in renewal) licenses - no more than 10 working days from the date of receipt in Roszdravnadzor (territorial authority) of properly issued application for renewal of the license and documents (data), stipulated in Item 16 Administrative regulations, in cases:

reorganization of the legal entity in the form of transformation;

reorganization of the legal entity in the form of merge;

changes of the name of the legal entity;

address modifications of the location of the legal entity;

address modifications of the place of implementation of medical activities;

changes of the name of the licensed type of activity, renewals of the license which is not containing lists of works, services which are carried out, are as a part of medical activities (for the licenses existing about day of entry into force of the Federal Law of May 4, 2011 with No. 99-FZ "About licensing of separate types of activity" <2> (further - the Federal Law of May 4, 2011 No. 99-FZ);

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<2> Russian Federation Code, 2011, No. 19, Art. 2716; 2020, No. 31, 5029.

changes according to regulatory legal act of the Russian Federation names of the licensed type of activity, the list of works, services which are carried out, appear as a part of medical activities if need of renewal of the license is determined by this regulatory legal act;

the terminations of medical activities for one or several addresses of its implementation provided by the license;

intentions of the licensee to make changes to the list of the performed works provided by the license, the rendered services constituting medical activities regarding the termination of performance of works, rendering services;

3) decision making about renewal (about refusal in renewal) licenses - no more than 30 working days from the date of receipt in Roszdravnadzor (territorial authority) of properly issued application for renewal of the license and documents (data), stipulated in Item 17 Administrative regulations, in cases:

intentions of the licensee to perform medical activities for the address of the place of implementation which is not provided by the license;

intentions of the licensee to perform works, to render the services constituting medical activities, which are not provided by the license;

4) the direction of the notification on provision (renewal) of the license - 3 working days after day of entering of record about provision (renewal) of the license into the register of licenses;

5) issue (direction) of the notification on refusal in provision (renewal) of the license - 3 working days from the date of decision making about refusal in provision (renewal) of the license;

6) provision of data from the register of licenses - 3 working days from receipt date in Roszdravnadzor (territorial authority) of the statement, stipulated in Item 19 Administrative regulations;

7) cancellation of the license according to the statement of the licensee - within 10 working days from the date of receipt in Roszdravnadzor (territorial authority) of properly issued application for the termination of medical activities.

13. The term of suspension of provision of the state service constitutes 30 calendar days from the date of receipt by the applicant of the notification of Roszdravnadzor (territorial authority) on need of elimination in 30-days time from the moment of receipt of the notification of the revealed violations and (or) submission of documents which are absent, in cases:

1) filing of application about provision of the license, Item 15 of Administrative regulations which is drawn up with violation, and submission of documents not in full;

2) filing of application about renewal of the license, drawn up with violation of Items 16 - 17 Administrative regulations, and submission of documents not in full.

The regulatory legal acts regulating provision of the state service

14. The list of the regulatory legal acts regulating provision of the state service is posted on the official site of Roszdravnadzor (territorial authorities), in the federal register and on the Single portal.

The exhaustive list of the documents necessary according to regulatory legal acts for provision of the state service and services which are necessary and obligatory for provision of the state service, subject to representation by the applicant, methods of their obtaining by the applicant, including electronically, procedure for their representation

15. For receipt of the license the license applicant represents (sends) the following documents (data) to Roszdravnadzor (territorial authority):

1) the statement for provision of the license in form according to Appendix No. 1 to Administrative regulations;

2) copies of the documents confirming availability at the license applicant belonging to it on the property right or on other legal cause of the buildings, structures, constructions and (or) rooms necessary for accomplishment of the declared works (services), the rights to which are not registered in the Unified State Register of Rights on real estate and transactions with it (if such rights are registered in the specified register, - data on these buildings, structures, constructions and (or) rooms);

3) copies of the documents confirming availability at the license applicant belonging to it on the property right or on other legal cause of medical products (the equipment, devices, devices, tools) necessary for accomplishment of the declared works (services);

4) copies of documents, confirmatory:

availability at the head of the medical organization, the deputy managers of the medical organization responsible for implementation of medical activities, the head of the structural unit of other organization responsible for implementation of medical activities, - the higher medical education, the postgraduate and (or) additional professional education provided by qualification requirements to specialists with the higher and postgraduate medical education in the field of health care, the certificate of the specialist, and also additional professional education and the certificate of the specialist in "the organization of health care and public health";

availability at the head of the organization, logging-in federal state sanitary and epidemiological surveillance, or his deputy responsible for implementation of medical activities, - the higher medical education, the postgraduate and (or) additional professional education provided by qualification requirements to Specialists with the higher and postgraduate medical education in the field of health care, the certificate of the specialist, and also additional professional education and the certificate of the specialist in "social hygiene and the organization of gossanepidsluzhba";

availability at the head of the structural unit of the medical organization performing medical activities - higher education, postgraduate (for specialists with medical education) and (or) the additional professional education provided by qualification requirements to specialists with the higher and postgraduate medical education in the field of health care and the certificate of the specialist (for specialists with medical education);

5) copies of the documents confirming availability at persons specified in the subitem 4 of Item 15 of Administrative regulations:

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