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Circulation of Immunobiologicals in the Russian market

Nana U. Bekhorashvili, Elena R. Zakharochkina, Ekaterina M. Grigorevskikh, Arus G. Margaryan, Diana I. Sologova


This study aimed at defining the peculiarities of immunobiologicals’ circulation in the ‎Russian pharmaceutical market. In the system analysis of the regulatory framework for the ‎national regulation of medicine circulation for 2014–2019, it has been revealed that the ‎requirements set to immunobiologicals were stricter. The comprehensive combination of the ‎pharmaceutical and sanitary-epidemiological regulation for all circulation subjects has been ‎an important feature. Since the end of 2019, manufacturers and holders of registration ‎certificates must comply with a new procedure for introducing vaccines, toxoids, toxins, ‎serums, immunoglobulins, and allergens into circulation. The Russian market of the basic ‎groups of immunobiologicals has largely depended on the development of the domestic ‎pharmaceutical industry, regulated by the Ministry of Industry and Trade of Russia‎‎‎.

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