2Application for pharmaceuticals registration, examination
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Summary of the procedure Payment of state duty for expertiseDecision regarding a registration and obtainment of certificate

Contact details

   

Entity in charge

Ministry of healthcare and social development

25, Neglinnaya str., office 150, Moscow
Phone: +7(495) 628-44-53 / +7(495) 627-29-44 
http://www.minzdravsoc.ru
   

Requirements

1. 1 - Application paper for state registration 
Application paper for state registration  (original)
Please find attached list of supported documents

Legal justification

1. 1 - Federal law "On turnover of medicines"  № 61-ФЗ dated 12.04.2010 
Federal law "On turnover of medicines" № 61-ФЗ dated 12.04.2010
2. 2 - Decree of RF Government № 650 dated 20.08.2010 
Decree of RF Government № 650 dated 20.08.2010
3. 3 - Decree of the Ministry of Healthcare and Social Development № 750н dated 26.08.2010 
Decree of the Ministry of Healthcare and Social Development № 750н dated 26.08.2010

Additional information

Only registered pharmaceuticals can be manufactured, for sale and in usage in Russia.
All new pharmaceuticals, registered pharmaceuticals made in new forms, in new measuring, with new supplements, reproduced pharmaceuticals, pharmaceuticals for animals’ treatment are to be registered.
Application form and supporting documents can be presented in person or by registered mail.
Application and all supporting documents are to be presented in Russian language, documents originated from abroad are to be officially translated into Russian language. Documents are to be presented both in papers and in electronic version (formats *doc., *xls., *pdf).

Decision on filing an expertise file is to be made within five days, subject of completeness of the documents and data provided.

All procedures, including expertises, should not take longer than 210 days.