GMP inspection

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In 2016 for the registration of new pharmaceuticals (p) all pharmaceutical companies must submit a copy of a statement of compliance with the requirements:

In 2016 for the registration of new pharmaceuticals (p) all pharmaceutical companies must submit a copy of a statement of compliance with the requirements:

Of good manufacturing practices (resolution of the Government of the Russian Federation 03.12.2015 No. 1314 "On determination of compliance of medicines manufacturers with the requirements of good manufacturing practice") issued by the authorized Federal Executive authority, if the manufacturing is performed outside of the Russian Federation, or a copy of the license, if the production is based in Russia. A similar requirement came into force on January 1, 2017 when confirming state registration and making changes to the registration dossier.

The Ministry of industry and trade of the Russian Federation (Ministry of industry and trade of the Russian Federation) is the authorized Executive body for inspection. The inspection is carried out by the Federal budgetary institution "State Institute of medicines and good practices" (FBU "GILS and NP") of the Ministry of industry and trade of the Russian Federation.

After the adoption of the law "on amendments to the Federal law" on circulation of medicinal products "no." 140-FZ "dated 04.06.2018," the procedure for registration of medicinal products produced outside the Russian Federation and the procedure for making changes to registration documents were simplified. However, the absence of a foreign pharmaceutical manufacturer's conclusion on its compliance with the requirements of the GMP rules issued by the Ministry of industry and trade of the Russian Federation is the basis for a decision to refuse state registration/re-registration and make a number of changes to the registration dossier that requires quality examination.

As part of this service, our specialists perform the following:

  • Consult on the current procedure for preparing and conducting an inspection of a foreign manufacturer. If necessary, organizes a preliminary audit of the production site;
  • Together with the manufacturer, prepare and agree on a package of documents for submission to the Ministry of industry and trade of Russia.
  • Assist in the preparation of responses to inspectors ' comments on the results of previous inspections (if necessary).
  • Submit a package of documents with an application to the Ministry of industry and trade of the Russian Federation and carry out all necessary communication with the authorized bodies on requests for additional materials and on approval of inspection dates (including the manufacturer in the inspection schedule of the FBU "GILS and NP").
  • If necessary, they accompany the inspectors during the inspection period at the factory, and provide assistance in communicating with the plant's employees and inspectors;
You need to know
Useful information on the legal basis for the circulation of medicines in the Russian Federation.
Useful information
Useful information
Useful information on the legal basis for the circulation of medicines in the Russian Federation.
Our team
Our team
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