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Marketing authorization

According to the legislative acts adopted in the Russian Federation, only drugs authorized for appropriate use on the territory of our country are subject to human use. In accordance with the Federal Law dd. 12.04.2010 No. 61-FZ "On Medicine Circulation", obtaining of marketing authorization is compulsory for:

According to the above-mentioned document, the state registration of medicinal products is carried out by the relevant authorized federal executive body – by the Ministry of Health of the Russian Federation, on the basis of a package of documents, i.e. registration dossier, as well as application for state registration of the medicinal product, within a period not exceeding one hundred and sixty business days from the date of the relevant application.

Thus, it is possible to single out the following key points for the registration of a medicinal product:

pplications for state registration of a medicinal product
registration dossier for a medicinal product, which must be submitted in the form of a general technical document in accordance with the Federal Law No. 61 dd. 12.04.2010.
when state registration of generic medicines it is allowed to include a review of scientific works on the results of preclinical trials of the reference medicinal product in the dossier instead of "Report of the developer on the results of its own preclinical trials of medicinal products" and to deliver the "Report on the results of bioequivalence studies of the generic medicinal product" instead of the drug clinical trials.

Our services include

The specialists of our company are ready to assist at any stage of the registration dossier formation.

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