160 Working Days
That is the term (from the date of accepting the application) according to the approved procedure for providing the public service of marketing authorization of medicinal drugs, reserved for preparation, issue to the applicant of the decision on public authorization of a medicinal drug and marketing authorization of a drug or a decision on refusal to issue a marketing authorization. This procedure is established in the Order of the Ministry of Healthcare of the Russian Federation of 21.09.2016 No725н On Approval of Administrative Regulation of the Ministry of Healthcare of the Russian Federation on Providing a Public Service on State Authorization of Medicinal Drugs published at the legal information web-site of the Russian MoH.
The document was registered at the Russian Ministry of Justice on 23.01.2017 No 45357. It was developed in full compliance with norms introduced according to FZ No 429-FZ of December 22, 2014 On Making Amendments into the Federal Law On Medicinal Drugs Circulation.