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Mandatory drug certification was canceled in Russia
The Russian government has established a new procedure for introducing drugs into civilian circulation. Now, instead of mandatory certification or the adoption of a declaration of conformity for the drug, manufacturers or organizations importing drugs into the country will have to submit data to Roszdravnadzor.
The new rules will enter into force on November 29. As noted in decree government, for the introduction of immunobiological preparations into circulation, it will be necessary to obtain permission from Roszdravnadzor.
They will introduce drugs into circulation with the involvement of testing laboratories of federal institutions. To assess the quality of the drugs, they will be able to send samples for testing to other accredited laboratories.
As for immunobiological preparations, the commission on the quality of such drugs will be introduced into circulation. It will include representatives of the Russian Ministry of Health, Roszdravnadzor, the Ministry of Industry and Trade, pharmaceutical associations and leading experts in this field.