On-site management for drug products, which manufacturing is performed outside the Russian Federation
If a foreign manufacturer plans the registration of his drug products in the Russian Federation he will need to get the conclusion on compliance of the human drug product manufacturer (foreign manufacturer) with the requirements of the Good Manufacturing Practice rules.
The presence of GMP certificate issued by the authorized body of the manufacturing country will not liberate from the obligation to pass Russian inspection. The manufacturer must be obligatory inspected by Russian inspectors and no exceptions are provided.
If in the process of drug manufacture some manufacturing sites take part they should all be inspected. A separate application is submitted for each production site and special inspections are performed. All documents are submitted in Russian including the main dossier of the production site.
The requirement for mandatory inspection of foreign manufacturers by Russian inspectors was introduced on 01/01/2016. The authorized executive body on inspection is the ministry of industry and trade of the Russian Federation (Minpromtorg of Russia)
The expert institution performing the inspection and processing of the inspection report is 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.
Our company provides a service for submitting an application on issue of Conclusion and accompanies the entire procedure up to the moment of issue of the Conclusion except inspectors accompaniment when leaving the site.
If you need more detailed information on all cooperation-related issues you may dial (499) 110-55-10 or use the feedback form on our website.