State Marketing Authorization

According to Part 1. art. 13 of Federal Law of the Russian Federation № 61-FZ , dated April 12, 2010  «On Medicine Circulation»  drug substances are put into civil commerce on the territory of the Russian Federation if they are licensed by an appropriate authorized federal executive agency.

According to Federal Law of the Russian Federation № 61-FZ «On Medicine Circulation» the following items must be licensed:

  • Original drug substances
  • Generics
  • New combinations of previously licensed drug products
  • Drug products licensed previously but produced in different formulations or dosage. 

Marketing authorization is issued by an appropriate authorized federal executive agency in the period not longer than two hundred and ten working days from the day of application acceptance. The above mentioned term includes time for second drug evaluation test or/and ethic test as per Federal Law 25 №61-FZ, dated April, 12 2010 №61-FZ « On Medicine Circulation ». The term of state licensing starts on the day of acceptance of market authorization application with all supporting documentation by the authorized agencies and finishes on the day of issue of the certificate for the drug product. Time for clinical trials is not considered in the term for state licensing.

We are eager to offer you full package of services for facilitating Market Authorization:

  • Representation of customer’s interests in Ministry of Health of the Russian Federation (without transition of any rights.)
  • Development of an optimized strategy
  • Formation, lodging and support o the dossier
  • Fast and proper translation of foreign documentation into the Russian language
  • Management and conduction of all studies necessary for the dossier
  • Market Authorization Consultations
  • Production of normative documentation for drug products
  • Production of design of primary and secondary package for drug products
  • Editing of documentation in the registration dossier
  • Obtaining of certificate and approved documentation from the registration dossier of the drug product