Work sequence

 1. 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.

2. The   procedure   of   Confirmation   of  State  Registration  is carried out  within  the  time-limit of 90 (ninety) working days and begins upon receipt of the application for Confirmation of the State Registration of the medicinal product with all other necessary documents attached to it and ends on the date of issuing of the unlimited Marketing Authorization.

 3. The procedure of making amendments to the regulatory documents for the approved medicinal products is carried out within the time-limit of 90 (ninety) working days (in case of positive resolution) and begins on the date of submitting an application for making amendments to the Ministry of Health and Social Development of RF (Minzdravsocrazvitiya Rossii).

 4. The quality control expertize of the API and expert quality reports drawn up by the committee of experts upon the results of this expertize and their forwarding to the Ministry of Health and Social Development of the Russian Federation (Minzdravsocrazvitiya Rossii)  is carried out within the time-limit of 60 (sixty) working days upon the date of receiving the corresponding task and the documents from the Ministry of Health and Social Development of the Russian Federation (Minzdravsocrazvitiya Rossii).