State Registration of medicinal products

In order to initiate the procedure of State Registration of a medicinal product, the manufacturer or its authorized  representative (Applicant) shall submit an application for the State Registration of the medicinal product, a document confirming payment of State duty  and other necessary documents, which are to be included into the Registration Dossier  to the corresponding authorized federal body of the executive branch, which is responsible for the State Registration of medicinal products in RF -  Ministry of Health and Social Development of the Russian Federation (Minzdravsocrazvitiya Rossii).

The procedure of State Registration of medicinal products is carried out by the Ministry of Health and Social Development of RF within the time-limit of 210 (two hundred and ten) working days. It begins upon receipt of the application for the State Registration of the medicinal product with all other necessary documents attached to it and ends on the date of issuing the Marketing Authorization. The time required for clinical studies performance is not included into the State Registration time calculation.