Lift Unnecessary Barriers
It is planned to make certain amendments into the procedure of launch of drugs to the market. A corresponding government decree On Introduction of Medicinal Drugs into Civil Circulation in the Territory of the Russian Federation has been prepared. According to the explanatory note, the document is aimed at lifting barriers for releasing medicinal drugs to civil circulation and relieving the cost loads for manufacturers.
It is suggested to exclude drugs from the joint list of products subject to compulsory certification. The out-of-date procedure of compulsory confirmation of compliance will be revoked.
It is suggested to effectuate release of MD into circulation based on the information provided by manufacturers and importing companies to the Roszdravnadzor information system. Special procedure needs to be established for immunobiological drugs.