The government gave Roszdravnadzor the right to issue permits for the import of unregistered drugs into the country for specific patients. The department also received the functions of registration, conducting clinical trials and monitoring the safety, quality and efficiency of medical devices in accordance with the rules of the Eurasian Economic Union.
“The project provides for the empowerment of Roszdravnadzor to issue, in accordance with the procedure established by the legislation of the Russian Federation, permits for the import of unregistered medical devices into the territory of the Russian Federation for the provision of medical care according to the vital indications of a particular patient; implementation of registration procedures for a medical device in accordance with the rules for registration and examination of the safety, quality and effectiveness of medical devices, approved by the decision of the Council of the Eurasian Economic Commission of February 12, 2016, “the government’s website says.
In recent years, it has not been possible to resolve a number of legal issues related to the import of drugs that have not passed Russian registration. The amendments to the legislation, thanks to which Roszdravnadzor will have the powers necessary for this process, were developed by the Ministry of Health. Unregistered imported drugs include vaccines.
Details – in the material “Kommersant” “Prolonged cluster therapy”.