General information

Medicinal products cannot be put into civil circulation in the territory of the Russian Federation, till they are approved by the corresponding authorized federal body of the executive branch - Ministry of Health and Social Development of the Russian Federation (Minzdravsocrazvitiya Rossii).

In accordance with Federal Act of RF № 61-FA "Of Drug Circulation" d/d April 12, 2010 the following medicinal products are subject to State Registration (State Approval):

1) original medicinal products;
2) generic medicinal products;
3) new combinations of previously approved medicinal products;
4) previously approved medicinal products, being manufactured now in another drug formulation and dosage form.

The State Registration of medicinal products is carried out subsequent to the results of both medicinal products expertize and ethical review regarding the expediency of clinical studies performance of these medicinal products.

The medicinal products expertize is carried out stepwise:

Step 1 - expertize of the documents for obtaining the official permission for clinical studies performance, except for the following medicinal products:

a) the medicinal products, which have been allowed for medical use in the territory of the Russian Federation for  twenty years, when it is impossible to perform bioequivalence studies;
b) the medicinal products, in respect of which international multicenter clinical studies have already been carried out, provided that  a part of these studies were carried out in the territory of the Russian Federation;

Step 2 - expertize of the proposed methods of quality control of both medicinal products and samples of medicinal products and a benefit-risk expertize. Both types of expertize are carried out after the clinical studies performance.

The Marketing Authorization for a medicinal product contains the description of its formulation and dosage form and has no expiration date, except for the Marketing Authorization which is issued for a five years' period for the first time registering medicinal products in the territory of the Russian Federation. Then, upon the expiration of the validity period and after the confirmation of the State Registration of such medicinal product, the unlimited Marketing Authorization can be obtained.