Confirmation of State Registration of medicinal products

The procedure of Confirmation of State Registration is carried out subsequent to the results of both the benefit-risk expertize and quality control expertize. The latter is to be carried out only in case of making amendments to the normative documents.

In order to initiate this procedure, the manufacturer or its authorized representative (Applicant) shall submit an application for Confirmation of the State Registration of the medicinal product, a document confirming payment of State duty and Periodic Safety Update Report (PSUR) to the corresponding authorized federal body of the executive branch - Ministry of Health and Social Development of the Russian Federation (Minzdravsocrazvitiya Rossii). Normative documents, instruction for medical application, proposed drug package design of both the primary and secondary (consumer) package form must be attached to the above application only in case of making amendments to these documents.

The whole procedure 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.