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Ministry of Justice

Russian Federation

On June 7, 2017 No. 46977

ORDER OF THE MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

of March 27, 2017 No. 133n

About approval of Administrative regulations of the Federal Service on supervision in health sector on provision of the state service in registration of medical products according to the Rules of registration and examination of safety, quality and efficiency of medical products approved by the Decision of Council of the Eurasian economic commission of February 12, 2016 No. 46

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 registration of medical products according to the Rules of registration and examination of safety, quality and efficiency of medical products approved by the decision of Council of the Eurasian economic commission of February 12, 2016 No. 46.

Minister

V. I. Skvortsova

Approved by the Order of the Ministry of Health of the Russian Federation of March 27, 2017, No. 133n

Administrative regulations of the Federal Service on supervision in health sector on provision of the state service in registration of medical products according to the Rules of registration and examination of safety, quality and efficiency of medical products approved by the Decision of Council of the Eurasian economic commission of February 12, 2016 No. 46

I. General provisions

Subject of regulation of Administrative regulations

1. The administrative regulations of the Federal Service on supervision in health sector (further - Roszdravnadzor) on provision of the state service in registration of medical products according to the Rules of registration and examination of safety, quality and efficiency of medical products approved by the decision of Council of the Eurasian economic commission of February 12, 2016 No. 46 (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, his officials, interactions of Roszdravnadzor with applicants, other public authorities, and also authorized bodies of state members of the Eurasian Economic Union (further respectively - state members, the Union), organizations and the organizations by provision of the state service.

These Administrative regulations do not extend to medical products, requirement for which arises in emergency situations or for diagnosis of new, natural and focal or especially dangerous infectious diseases which address is regulated by the legislation of state members.

Circle of applicants

2. Applicants on provision of the state service (further - applicants) are stipulated in Item 3 Rules of registration and examination of safety, quality and efficiency of the medical products approved by the Decision of Council of the Eurasian economic commission of February 12, 2016 No. 46 (the official site of the Eurasian Economic Union of http://www.eaeunion.org/, on July 12, 2016):

1) the producer of medical product which is resident of state member;

2) authorized representative of the producer of medical product.

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) by means of placement of information, including on graphics of acceptance of applicants and phone numbers for reference (consultations) on the official site of Roszdravnadzor on the information and telecommunication Internet: www.roszdravnadzor.ru (further - the official site of Roszdravnadzor);

2) in the Federal state information system "Single Portal of the State and Municipal Services (Functions)": www.gosuslugi.ru (further - the Single portal of the state and municipal services (functions));

3) at information stands in reception of Roszdravnadzor;

4) on phone numbers for reference;

5) in mass media.

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

109074, Moscow, Slavyanskaya Ploshchad, 4, structure 1.

Working schedule: on weekdays from 9-00 to 18-00 o'clock (Friday from 9-00 to 16 o'clock 45 minutes). Lunch break from 13-00 to 13 o'clock 45 minutes;

Phones for reference: +7 (495) 698-16-14; +7 (495) 698-45-38.

Phones of Management of the organization of the state control and registration of medical products of Roszdravnadzor: +7 (499) 578-02-99.

4. Data on the federal executive bodies participating in provision of the state service:

1) Federal Tax Service (FNS of Russia):

127381, Moscow, Neglinnaya st., 23;

phone for reference: +7 (495) 913-00-09;

address of the official site: www.nalog.ru;

working schedule: on weekdays from 9-00 to 18-00 o'clock (Friday from 9-00 to 16 o'clock 45 minutes). Lunch break from 13-00 to 13 o'clock 45 minutes;

2) Federal Treasury (Federal Treasury):

109097, Moscow, Ilyinka st., 9;

phones for reference: +7 (495) 984-12-97, +7 (495) 984-13-36.

address of the official site: www.roskazna.ru;

operating time: on weekdays from 9-00 to 18-00 o'clock (Friday from 9-00 to 16 o'clock 45 minutes). Lunch break from 13-00 to 13 o'clock 45 minutes.

5. At information stands of Roszdravnadzor, the following information materials and documents are posted on the official site of Roszdravnadzor:

this Administrative regulations and the list of the regulatory legal acts of the Russian Federation regulating questions of provision of the state service;

the schedule of acceptance of applicants and phone numbers for reference (consultations);

bank details for payment of the state fee;

models of execution of statements and documents which are submitted for receipt of the state service;

procedure for receipt of consultations;

procedure for appeal of decisions, actions or failure to act of the officials providing the state service;

data on the e-mail address of the Single portal.

6. Informing is carried out in oral or written form in case of the personal address of the applicant or by means of telephone communication.

Requirements to information provided to applicants are completeness, reliability, clearness in statement, presentation of forms, convenience and availability, efficiency.

II. Standard of provision of the state service

Name of the state service

7. The state service in registration of medical products according to the Rules of registration and examination of safety, quality and efficiency of medical products approved by the decision of Council of the Eurasian economic commission of February 12, 2016 No. 46.

The name of the federal executive body providing the state service

8. The state service is provided by Roszdravnadzor.

9. By provision of the state service Roszdravnadzor interacts with:

1) Federal Tax Service;

2) Federal Treasury;

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