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It is registered

Ministry of Justice

Russian Federation

On December 22, 2020 No. 61679

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

of November 30, 2020 No. 11205

About approval of Administrative regulations of the Federal Service on supervision in health sector on provision of the state service in issue of import permits on the territory of the Russian Federation of medical products for the purpose of their state registration

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), subitem 5.1.2.2 of the Regulations on the Federal Service on supervision in health sector approved by the order of the Government of the Russian Federation of June 30, 2004 No. 323 (The Russian Federation Code, 2004, No. 28, Art. 2900; 2020, to No. 37, of the Art. 5719), I order:

1. Approve the enclosed Administrative regulations of the Federal Service on supervision in health sector on provision of the state service in issue of import permits on the territory of the Russian Federation of medical products for the purpose of their state registration.

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

Head

A. V. Samoylova

Approved by the Order of the Federal Service of the Russian Federation on supervision in health sector of November 30, 2020, No. 11205

Administrative regulations of the Federal Service on supervision in health sector on provision of the state service in issue of import permits on the territory of the Russian Federation of medical products for the purpose of their state registration

I. General provisions

Subject of regulation of Administrative regulations

1. The administrative regulations of the Federal Service on supervision in health sector on provision of the state service in issue of import permits on the territory of the Russian Federation of medical products for the purpose of their state registration (further respectively - Administrative regulations, the state service) establish terms and the sequence of ministerial procedures (actions) of officials of the Federal Service for supervision in health sector (further - Roszdravnadzor), order of interaction between structural divisions of Roszdravnadzor, his officials, and also interactions of Roszdravnadzor with applicants, other public authorities and local government bodies, the organizations by provision of the state service.

Circle of applicants

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

1) producer of medical product;

2) the authorized representative of the producer of medical product who is the legal entity or the individual entrepreneur registered in the territory of the Russian Federation, authorized by the producer of medical product to represent its interests concerning the address of medical product in the territory of the Russian Federation, including the related assessment procedures of compliance, state registration and addressed to which the registration certificate on medical product can be issued.

Requirements to procedure for informing on provision of the state service

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

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

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

on the official site of Roszdravnadzor on the Internet (further - the official site of Roszdravnadzor, Internet network);

at information stands in reception on work with addresses of citizens of Roszdravnadzor;

on phone numbers for reference.

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

on the official site of Roszdravnadzor;

on the Single portal;

in the federal register;

at information stands in reception on work with addresses of citizens.

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

6. On the official site of Roszdravnadzor and on the Single portal the following information is placed:

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

the exhaustive list of the documents necessary for provision of the state service, the requirement to execution of the specified documents, and also the list of documents which the applicant has the right to provide on own initiative;

circle of applicants;

term of provision of the state service;

data on the course of provision of the state service;

results of provision of the state service, procedure for submission of the document which is result of provision of the state service;

about the applicant's right to pre-judicial (extrajudicial) appeal of actions (failure to act) and the decisions made (performed) during provision of the state service;

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

7. The refusal in the acceptance of request and other documents necessary for service provision, and also refusal in service provision is not allowed if the request and documents necessary for service provision are given according to information on terms and procedure for provision of the service published on the Single portal, portals of services and the official sites.

8. Information on the Single portal and the official site of Roszdravnadzor 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

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