The Ministry of industry and trade of the Russian Federation
FSI «SID & GP»
+7 (495) 676-43-60 109044, Moscow, Lavrov lane., 6

Inspectorate

Organization and conduct of foreign medicines manufacturers inspection on compliance with GMP rules

General info

In order to implement the Rules for organization and conduct of medicines manufacturers inspection on compliance with the requirements of the rules of Good Manufacturing Practice, as well as issuing certificates of compliance of a medicines manufacturer to the specified requirements, approved by the Government Decree No. 1314 dated December 03, 2015 «On determination of medicines manufacturers compliance with the requirements of the rules of Good Manufacturing Practice» and on the basis of the Order of the Ministry of Industry and Trade of the Russian Federation «On determination of Federal State Institution «State Institute of Drugs and Good Practices» of the Ministry of Industry and Trade of the Russian Federation as the authorized agency for conduct of inspection» No. 4184 dated December 21, 2015, Federal State Institution «State Institute of Drugs and Good Practices» conducts inspection of foreign manufacturers of medicinal products for medical use.

The service for issuing a certificate on compliance of a manufacturer of medicinal products for medical use on compliance with the requirements of the rules of Good Manufacturing Practice is provided by the Ministry of Industry and Trade of the Russian Federation, located at: 109074, Kitaygorodsky PR, 7, Moscow, Russian Federation.

Schedule:

  • Monday, Tuesday, Wednesday, Thursday – from 9.00 to 18.00;
  • Friday – from 9.00 to 16.45;
  • Saturday – Sunday – days off.

Information on the location, schedule (mode) of the work of the Ministry of Industry and Trade of the Russian Federation is placed in the Federal State Information System «Unified portal of state and municipal services (functions)» (www.gosuslugi.ru) (hereinafter – Portal), on the official website of the Ministry of Industry and Trade of the Russian Federation (www. minpromtorg.gov.ru; www.minpromtorg.rf) in the information and telecommunication network «Internet» (hereinafter – Site), in the information and electronic terminal in the foyer of the Minpromtorg of Russia’ building.

Reference phones: (495) 632-87-00; (495) 632-89-37; (495) 539-21-29; (495) 647-87-37; (495) 632-85-89.

The necessary background information can also be obtained during working hours by the telephone number of the Minpromtorg of Russia: +7 (495) 539-21-87 (extension 27-55).

We draw attention of foreign manufacturers – all the documents should be submitted in the Russian language, including the main dossier of a production site!

Schedule of working hours of Federal State Institution «State Institute of Drugs and Good Practices»:

  • Monday, Tuesday, Wednesday, Thursday – from 9.00 to 18.00;
  • Friday – from 9.00 to 16.45;
  • Saturday – Sunday – days off.

Reference phone: +7 (495) 676-43-60

For more information – e-mail addresses:

Chadovann@gilsinp.ru, novichkova@gilsinp.ru, nikolko.tv@gilsinp.ru

The site contains:

  • regulatory legal acts, departmental orders
  • flow-diagram of the services provision for issuance of GMP Certificates (a foreign manufacturer)
  • fill-in forms:
    • application form for issuing a certificate
    • the form «Information on revealed non-compliances of medicines quality with the established requirements»
    • the form «List of medicines produced at the production site of a manufacturer or foreign manufacturer, the inspection of which is carried out»
    • the form «Letter on the consent of a foreign manufacturer on inspection»
    • payment order (Mipromtorg)
    • requisites of FSI «SID and GP»