In order for a drug to enter the Russian market, it is required to go through several stages, the very first of which is an affirmative registration, or revision examination. The process involves checking your product by the state for safety, efficacy in relation to the indicated pharmacological properties. The end result is the issuance of an affirmative conclusion for use.

The procedure for the authorization of drugs, as well as medical devices, is established in Federal Law No. 61. Also, it is mandatory for the procedure are proposals issued by such bodies as the Ministry of Industry and Trade, the Ministry of Health, Roszdravnadzor. The period of validity of the initial authorization on the territory of the Russian Federation is 5 years.

Article 13. Medicinal product state authorization Medicinal product state authorization

ANO NSC of Pharmacovigilance can help you to register a drug efficiently, quickly, and professionally. To use this service, you can fill out the form — / or call (24/7) 8-800-777-86-04