Circle of applicants
2. The applicant for the provision of public services (hereinafter referred to as the "applicants") is the legal entity provided for in paragraph 19, a legal entity eligible to apply for registration, confirmation of registration (re-registration, registration renewal), modification of the registration dossier of drugs, other procedures related to registration, and carrying responsibility for the reliability of the information contained in the documents submitted by him in the registration dossier.
Requirements for the procedure for informing about the provision of public service
3. Information on the procedure for providing public services is provided by the Ministry of Health of Russia:
1) by posting information, including the schedule for receiving applicants and phone numbers for inquiries (consultations) on the official website of the Ministry of Health of Russia in the information and telecommunication network Internet: www.rosminzdrav.ru (hereinafter referred to as the official website of the Ministry of Health of Russia);
2) in the Federal State Information System "Unified Portal of State and Municipal Services (Functions)": www.gosuslugi.ru (hereinafter - the Unified Portal of State and Municipal Services (Functions));
3) at information stands in the reception room of the Ministry of Health of Russia;
4) by phone numbers for reference;
5) in the mass media.
Information on the procedure for providing public services is provided by the Ministry of Health of the Russian Federation at the address:
127994, Moscow, Rakhmanovsky per., 3.
Opening hours: on weekdays from 9-00 hours to 18-00 hours (Friday from 9-00 hours to 16 hours 45 minutes). Lunch break from 12-00 hours to 12 hours and 45 minutes.
The phone for information: +7 (495) 628-44-53, (495) 627-29-44.
The phone number of the registration of medicinal products:
+7 (495) 627-24-00, ext. 2020, 2021, 2022.
The phone of the department for regulating the circulation of registered medications:
+7 (495) 627-24-00, ext. 2030, 2031, 2032, 4912.
4. Information on federal executive bodies involved in the provision of public services:
1) The Federal Tax Service (Federal Tax Service of Russia):
127381, Moscow, Neglinnaya ul., 23;
phone for inquiries: +7 (495) 913-00-09;
the official website address: www.nalog.ru;
schedule: on weekdays from 9-00 hours to 18-00 hours (Friday from 9-00 hours to 16 hours 45 minutes). Lunch break from 13-00 hours to 13 hours 45 minutes;
2) Federal Treasury (Treasury of Russia):
109097, Moscow, Ilinka Str., 9;
telephones for information: +7 (495) 984-12-97, +7 (495) 984-13-36.
the official website address: www.roskazna.ru;
working hours: on weekdays from 9-00 hours to 18-00 hours (Friday from 9-00 hours to 16 hours 45 minutes). Lunch break from 13-00 hours to 13 hours and 45 minutes.
3) The Ministry of Industry and Trade of the Russian Federation (Minpromtorg of Russia)
109074, Moscow, Kitaygorodsky Proyezd, house 7;
phone for information: +7 (495) 539-21-87;
the official website address: www.minpromtorg.gov.ru;
working hours: on weekdays from 9-00 hours to 18-00 hours (Friday from 9-00 hours to 16 hours 45 minutes). Lunch break from 12-00 hours to 12 hours and 45 minutes.
5. At the information stands of the Ministry of Health of Russia, on the official website of the Ministry of Health of Russia the following information materials and documents are posted:
the present Administrative Regulations and the list of regulatory legal acts of the Russian Federation regulating the issues on the provision of public services;
the schedule for the reception of applicants and phone numbers for references (consultations);
banking details for payment of state fee;
samples of registration of applications and documents that are submitted for obtaining a public service;
the procedure for obtaining advice;
the procedure for appealing against decisions, actions or omissions of officials providing public services;
information about the electronic address of the Single Portal.
6. Informing is carried out in oral or written form at personal appeal of the applicant or by means of telephone communication.
Requirements for information provided to applicants are completeness, reliability, clarity in presentation, visibility of forms, convenience and accessibility, efficiency.
II. Standard for the provision of public services
Name of state service
7. The state service for registration of drugs intended for circulation on the general market of medicinal products within the framework of the Eurasian Economic Union, in accordance with the Rules.
The name of the federal executive body, providing state service
8. The state service is provided by the Ministry of Health of Russia.
9. In the provision of public services, the Ministry of Health of Russia interacts with:
1) the Federal Tax Service;
2) the Federal Treasury;
3) the Federal Service for Supervision of Health Care (Roszdravnadzor);
4) Ministry of Industry and Trade of the Russian Federation;
5) Authorized bodies (expert organizations) of the Member States of the Union.
6) The Eurasian Economic Commission.
7) Expert Committee on medicines.
10. It is prohibited to require the applicant to carry out actions, including approvals, necessary for obtaining a public service and related to applying to other state bodies and organizations, except for receiving services included in the list of services that are necessary and mandatory for