Procedure for registration of drugs and cosmetics in the Russian Federation and foreign countries

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DOI: https://doi.org/10.29296/25419218-2019-05-01
Issue: 
5
Year: 
2019

V.I. Gegechkori, T.I. Kobakhidze, P.O. Parkhimovich, N.V. Gorpinchenko, O.I. Perederyaev I.M. Sechenov First Moscow State Medical University (Sechenov University), 8, Trubetskaya St., Build. 2, Moscow 119048, Russian Federation

Based on the analysis of legal issues and documentation in the field of statutory regulation of the circulation of medicines and cosmetics, the authors provide an overview of the procedure for registration of medicines and cosmetics in the Russian Federation, the European Union, and the USA. The procedure for registration of Russian and imported medicines, as well as cosmetics in the Russian Federation and foreign countries is provided at the federal level and has a number of substantial differences, the purpose of which is to obtain information on the efficacy and safety of a product.
Keywords: 
registration
certification
drugs
cosmetics
regulatory documentation
References: 
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  2. Regulation (EC) № 726/2004 of The European Parliament and of The Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. [Electronic resource]. Access mode: http://pharmadvisor.ru/document/tr3540/ (Accessed January 21, 2019) (in Russian)
  3. United States Code. Title 21. Food And Drugs. Chapter 9. «The Federal Food, Drug, and Cosmetic Act». [Electronic resource]. Access mode: http://uscode.house.gov/browse/prelim@title21/chapter9&edition=prelim (Accessed January 21, 2019)
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