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Ministry of Justice

Russian Federation

On September 12, 2012 No. 25444

ORDER OF FEDERAL SERVICE FOR THE OVERSIGHT OF CONSUMER PROTECTION AND WELFARE OF THE RUSSIAN FEDERATION

of July 23, 2012 No. 781

About approval of Administrative regulations of Federal Service for the Oversight of Consumer Protection and Welfare on provision of the state service in state registration for the first time implemented in production and earlier not used chemical, biological substances and the medicines potentially dangerous to the person produced on their basis (except medicines); the separate types of products constituting potential danger for the person (except medicines); separate types of products, including the foodstuff for the first time imported on customs area of the Customs union

(as amended on 07-04-2016)

According to the Federal Law of 27.07.2010 No. 210-FZ "About the organization of provision of the state and municipal services" (The Russian Federation Code, 2010, No. 31, Art. 4179; 2011, No. 15, Art. 2038; No. 27, Art. 3880; No. 29, Art. 4291; No. 30 (p. I), Art. 4587; No. 27, the Art. 3873), orders of the Government of the Russian Federation of 30.06.2004 No. 322 "About approval of the Regulations on Federal Service for the Oversight of Consumer Protection and Welfare" (The Russian Federation Code, 2004, No. 28, Art. 2899; 2006, No. 22, Art. 2337, No. 52, Art. 5587; 2008, No. 40, Art. 4548, No. 46, Art. 5337; 2009, No. 30, Art. 3823; No. 33, Art. 4081; 2011, No. 14, Art. 1935; No. 43, Art. 6079; No. 44, Art. 6272; 2012, No. 27, the Art. 3729) and of 16.05.2011 №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, 22, of the Art. 3169) I order to No.:

approve the enclosed Administrative regulations of Federal Service for the Oversight of Consumer Protection and Welfare on provision of the state service in state registration for the first time implemented in production and earlier not used chemical, biological substances and the medicines potentially dangerous to the person produced on their basis (except medicines); the separate types of products constituting potential danger for the person (except medicines); separate types of products, including the foodstuff for the first time imported on customs area of the Customs union.

Head

G. G. Onishchenko

Approved by the Order of Federal Service for the Oversight of Consumer Protection and Welfare of the Russian Federation of July 23, 2012, No. 781

Administrative regulations of Federal Service for the Oversight of Consumer Protection and Welfare on provision of the state service in state registration for the first time implemented in production and earlier not used chemical, biological substances and the medicines potentially dangerous to the person produced on their basis (except medicines); the separate types of products constituting potential danger for the person (except medicines); separate types of products, including the foodstuff for the first time imported on customs area of the Customs union

I. General provisions

Subject of regulation of regulations

1. Administrative regulations of Federal Service for the Oversight of Consumer Protection and Welfare (further - Rospotrebnadzor) on provision of the state service in state registration for the first time implemented in production and earlier not used chemical, biological substances and the medicines potentially dangerous to the person produced on their basis (except medicines); the separate types of products constituting potential danger for the person (except medicines); separate types of products, including the foodstuff for the first time imported on customs area of the Customs union (further - Administrative regulations), the standard and procedure for provision of the state service in Rospotrebnadzor determines (further - the state service).

Circle of applicants

2. Applicants on receipt of the state service are the legal entities and physical persons performing production in the territory of the Customs union, import to customs area of the Customs union and the address on customs area of the Customs union of products included in the Single inventory which are subject to sanitary and epidemiological surveillance (control) on customs border and customs area of the Customs union approved by the Decision of the Commission of the Customs union of May 28, 2010 N 299 (further - the Single list), and also in the cases provided by technical regulations of the Customs union.

For the controlled goods made on customs area of the Customs union, applicant is the manufacturer (producer) of controlled goods or person authorized by it in accordance with the established procedure.

For the controlled goods made out of customs area of the Customs union, applicant is the manufacturer (producer), the supplier (importer) of controlled goods or person authorized by it in accordance with the established procedure.

Requirements to procedure for informing on provision of the state service

3. Informing applicants on provision of the state service is provided directly in Rospotrebnadzor and its territorial authorities:

with use of means of telephone communication, electronic informing;

by means of placement in information and telecommunication networks public (including on the Internet), publications in mass media, editions of information materials (brochures, booklets, etc.).

4. Data on the locations of territorial authorities of Rospotrebnadzor contain on the official site of Rospotrebnadzor in the Internet (http://www.rospotrebnadzor.ru/) and the official sites of territorial authorities of Rospotrebnadzor on the Internet, and also at information stands of territorial authorities of Rospotrebnadzor.

The list of territorial authorities of Rospotrebnadzor is given in appendix No. 1 to Administrative regulations.

5. Information on procedure for provision of the state service is provided:

directly in premises of Rospotrebnadzor, territorial authorities of Rospotrebnadzor;

with use of means of telephone communication, electronic informing and the electronic equipment;

by means of placement in information and telecommunication networks public, including on the official site of Rospotrebnadzor on the Internet (http://www.rospotrebnadzor.ru/) (further - the official site of Rospotrebnadzor), and also in the federal state information system "Single Portal of the State and Municipal Services (Functions)" (further - the Single portal of the state and municipal services (functions)) (http://www.gosuslugi.ru/).

6. Transfer of documents by applicants for provision of the state service is performed to addresses of Rospotrebnadzor and its territorial authorities available on the official site of Rospotrebnadzor and its territorial authorities.

7. Reception hours of applicants:

          Day of the week           

          Operating mode           

Monday                      

          10.00 - 12.00          

Tuesday                          

          13.00 - 15.00          

Environment                            

          10.00 - 12.00          

Thursday                          

          13.00 - 15.00          

8. Provision of information (consultation) on provision of the state service is performed by the specialists providing the state service including the specialists who are specially allocated for provision of consultations.

9. Consultations are provided according to written addresses, in case of the personal address, and also by means of the official site (http://www.rospotrebnadzor.ru), phone or e-mail.

In case of consultations according to written addresses the answer to the address goes by mail to the applicant in time, not exceeding 30 calendar days from the moment of receipt of the written address.

Rospotrebnadzor location: 127994, Moscow, Vadkovsky Pereulok, 18, structures 5 and 7.

Phone for reference: +7 (499) 973 26 90.

Fax: +7 (499) 973 26 43.

Official site: www.rospotrebnadzor.ru.elektronny the address for the direction of addresses: depart@gsen.ru.

10. Informing on the course of provision of the state service is performed by specialists in case of personal contact with applicants, with use of means of the Internet (the address on the Internet of http://www.rospotrebnadzor.ru/activity/gosreg/), mail, telephone communication, by e-mail.

The applicants who provided to Rospotrebnadzor and its territorial authorities documents for state registration of products are without fail informed by specialists:

about suspension of state registration of products;

about refusal in state registration of products;

about date of completion of document creation and possibility of their obtaining.

In case of receipt of the inquiry sent by the applicant who provided the statement for carrying out state registration of products, substances, medicines to Rospotrebnadzor (its territorial authority) (about modification of the certificate on state registration of products) by means of the federal state information system "Single Portal of the State and Municipal Services (Functions)", the notification on the course of provision of the state service goes to single personal account, and also, at the choice of the applicant, to the e-mail address specified to them or phone number.

The notification on the course of provision of service goes no later than one working day after completion of each ministerial procedure.

11. The information materials concerning provision of the state service are posted in appropriate section of the official site of Rospotrebnadzor and its territorial authorities.

12. At information stands of Rospotrebnadzor and information stands of territorial authorities of Rospotrebnadzor, and also on the official site of Rospotrebnadzor and the websites of territorial authorities of Rospotrebnadzor the following information is placed:

extraction from the legislative and other regulatory legal acts containing the regulations regulating provision of the state service; the text of Administrative regulations with appendices (the complete version and extraction, including the application form about state registration of products);

lists of the documents necessary for state registration of products, and requirements imposed to these documents; application form;

size and details of the state fee;

location, schedule (mode) of work, phone numbers, address of the official site and e-mail;

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