3Inspection of the application and obtainment of license
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Summary of the procedure Application for the licensing of pharmaceuticals productionNo further step

Contact details

 

Entity in charge

Ministry of Industry and Trade

Kitaygorodsky pr-d, 7, 109074 Moscow
Phone: +7 (495) 710-52-66
http://www.minpromtorg.gov.ru/

Unit in charge

Dept. of chemical-engineering and bioengineering technologies

Mon: 09:30-17:00
Tue: 09:30-17:00
Wed: 09:30-17:00
Thu: 09:30-17:00
Fri: 09:30-15:45
Sat: cerrado
Sun: cerrado
 

Legal justification

1. 1 - Federal Law dated 08.08.2001 No 128-FZ «On Licensing of certain kinds of activities» 
Federal Law dated 08.08.2001 No 128-FZ «On Licensing of certain kinds of activities»
2. 2 - Federal law "On turnover of medicines"  № 61-ФЗ dated 12.04.2010 
Federal law "On turnover of medicines" № 61-ФЗ dated 12.04.2010
3. 3 - Decree of RF Government № 650 dated 20.08.2010 
Decree of RF Government № 650 dated 20.08.2010
4. 4 - Decree of RF Government № 684 dated 03.09.2010 
Decree of RF Government № 684 dated 03.09.2010

Additional information

Inspection mainly aimed at checking that the application is full and all supporting documents needed are provided and at checking that data, documents and materials presented are reliable as well as at checking premises and equipment of the applicant, technologies and security policies in use, staff education and qualification.

After application and all supporting documents are presented there is a period of 45 days available for a entity of charge to make a decision.

The applicant is to be informed about a decision in written form.