ORDER OF THE MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

of March 25, 2016 No. 184n

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 order of the Government of the Russian Federation of May 16, 2011 No. 373 "About development and approval of administrative regulations of execution of the state functions and administrative regulations of provision of the state services" (The Russian Federation Code, 2011, No. 22, Art. 3169; No. 35, Art. 5092; 2012, No. 28, Art. 3908; No. 36, Art. 4903; No. 50, Art. 7070; No. 52, Art. 7507; 2014, 5, of the Art. 506) I order to No.:

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.

Approved by the Order of the Ministry of Health of the Russian Federation of March 25, 2016, No. 184n

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 in health sector (further - Roszdravnadzor) on provision of the state service in issue of the import permit on the territory of the Russian Federation of medical products for the purpose of state registration (further respectively - Administrative regulations, the state service) determine terms and the sequence of ministerial procedures (actions) of Roszdravnadzor performed within provision of the state service and also order of interaction between structural divisions of Roszdravnadzor by supervision, his officials, interactions of Roszdravnadzor with applicants.

Circle of applicants

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

1) producer of medical product;

2) the authorized representative of the producer of medical product (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).

Requirements to procedure for informing on provision of the state service

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

1) directly in Roszdravnadzor building with use of means of evident information, including on Roszdravnadzor location, about graphics of acceptance of applicants and phone numbers for reference (consultations), including information stands and means of informing with use of information and telecommunication technologies;

2) by means of use of telephone, mail service, and also e-mail;

3) by means of placement of information on the official site of Roszdravnadzor on the Internet (further - the official site of Roszdravnadzor) (www.roszdravnadzor.ru), in the federal state information system "Single Portal of the State and Municipal Services (Functions)" (further - the Single portal) (www.gosuslugi.ru).

4. Information on procedure for provision of the state service is provided on a grant basis.

5. On the official site of Roszdravnadzor, on the Single portal the following information on procedure for provision of the state service is placed:

1) copies of the regulatory legal acts regulating activities for provision of the state service;

2) text of Administrative regulations.

6. Provision of the state service and informing on procedure for its provision is performed by Roszdravnadzor for the address: 109074, Moscow, Slavyanskaya Ploshchad, 4, structure 1.

7. Operating time: Monday - Thursday from 9:00 till 18:00 (Friday from 9:00 to 16:45).

Lunch break from 13:00 till 13:45.

The days off: Saturday, Sunday.

Phones for reference: +7 (495) 698-45-38, +7 (499) 578-02-30,

+7 (499) 578-01-61, +7 (499) 578-01-78.

General service desk: +7 (495) 698-45-38, +7 (499) 578-02-30.

E-mail address: info@roszdravnadzor.ru.

8. The application for issue of the import permit for the territory of the Russian Federation of medical products for the purpose of their state registration can be submitted to Roszdravnadzor in electronic form, certified by the strengthened qualified digital signature.

II. Standard of provision of the state service

Name of the state service

9. 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.

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