The state Duma adopted the law poradce entering the civil turnover of medicines, RIA Novosti reports. It establishes a mechanism to market for drug manufacturers and importers by Roszdravnadzor information about the quality or permit for immunological products.
For imported to the Russian Federation of drugs, except for immunobiological medicines, the organization must submit to Roszdravnadzor certificate of the manufacturer and confirmation of the responsible person of this organization on the conformity of imported drugs the requirements set during its state registration. In respect of the first three series of the drug for medical use, for the first time manufactured or imported in the Russian Federation, submitted additional test report by an accredited in accordance with the legislation of the Russian Federation Federal state budgetary institutions, according to medication quality indicators provided for regulatory compliance documentation.
The law also requires state regulation of the entry of immunobiological drugs in civil circulation by the issuance of the permit by the health Ministry. The submission of documents and information not required for drugs intended for clinical trials, assessment of drugs in the purpose of state registration, and unregistered medicines for rendering medical care according to vital indications of the individual patient.
The second reading of the bill was amended, according to which manufacturers of drugs or organizations, carrying out their import in the Russian Federation, must submit to Roszdravnadzor the test report of the drug annually no later than February 1, and to notify at least one year before the planned termination of production of medicines or their importation into the Russian Federation.