2Application for the licensing of pharmaceuticals production
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Summary of the procedure Payment of the state feeInspection of the application and obtainment of license

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
 

Requirements

1. 1 - Application 
Application  (original)

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

Needed documents include:
-copies of articles of association;
-state duty payment receipt;
(a) list of medicines to be produced;
(b) documents on technologies assuring the quality of the products;
(c) copies of documents certifying producer`s ownership (or other legal cause allowing operation) of premises and facilities; <>(d) copies of documents authorizing the legal entity to operate premises and facilities (or production facilities only) owned by other companies producing pharmaceuticals (agreements, contracts, certificates, etc.);
(e) copies of sanitary and epidemiological inspection report certifying conformity of potential production with sanitary regulations;
(f) copies of documents (diplomas, certificates, etc) certifying that qualifications of persons involved in production, quality assurance and marking of products meet the licensing requirements.

Copies not certified by a notary need attachment of originals.