The Ministry of Health of the Russian Federation makes a decision on a pharmaceutical product registration based on results of evaluations performed by the lower institution – the Federal State Budgetary Institution “Scientific Center for Evaluation of Medicinal Products" of the Ministry of Health of the Russian Federation (FSBI SCEMP (www.regmed.ru)). The FSBI SCEMP evaluates the proposed drug quality control methods and quality of submitted samples of a drug, and also evaluates the expected benefit to possible risk ratio which is done after the clinical study of a drug. To date, the FSBI SCEMP of the Ministry of Health of the Russian Federation has been prohibited to render services on pharmaceutical product evaluation directly to applicants in the course of the registration process. As a budgetary institution, the FSBI SCEMP only performs evaluations for the Ministry of Health of the Russian Federation upon receipt of their instructions.
An applicant pays a state duty (MoH fees) to the account of the Ministry of Health of the Russian Federation for state registration or introduction of changes (amount of the state duty; banking details for payment of the state duty)
For interaction with applicants, a new state portal grls.rosminzdrav.ru was created. The portal contains public (accessed without a password) and restricted information (accessed via a personal account protected by a password assigned). The public information is the State Register of pharmaceutical products and the State Register of selling price limits.
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