The government will strengthen control over quality of medicines sold
Moscow. 26 Jan. INTERFAX.RU Prime Minister of Russia Dmitry Medvedev ordered to submit to the state Duma a bill on the establishment of an effective mechanism for “graduation” control of medicines, reported on Friday on the website of the Cabinet of Ministers.
“Under the bill manufacturers of domestic drugs for medical use before being put into circulation would be required to submit to Roszdravnadzor the document of the producer confirming the quality of the drug and evidence of the authorized person of the manufacturer on the conformity of the medicinal product with the requirements established in state registration”, — stated in the message.
In respect of imported drugs organization dedicated to the importation, will have to submit to Roszdravnadzor certificate of the manufacturer and confirmation of the responsible person of this organization on the compliance of imported drug the requirements set during its state registration.
Also, according to the bill, it is proposed to provide a healthcare test Protocol the first three series of drugs, first produced in Russia or imported into Russia.
The tests imposed on subordinated to the Ministry of health and Roszdravnadzor Federal state budgetary institution having a legitimate accreditation.
Introduction into civil circulation of each series of immunobiological medicinal products (domestic and imported) will be based on the permit issued by the health Ministry. It will take into account compliance with a series of requirements established in the state registration of medicines issued by the Federal Agency.