NORMATIVE AND LEGAL REGULATION FOR MANURACTURE OF MEDICINES FOR VETERINARY USE

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DOI: https://doi.org/None
Issue: 
7
Year: 
2017

A.A. Deltsov (1), VetDr; Professor I.V. Kosova (2), PhD 1-K.I. Skryabin Moscow State Academy of Veterinary Medicine and Biotechnology; 23, Academician Skryabin St., Moscow 109472, Russian Federation; 2-Peoples’ Friendship University of Russia; 6, Miklukho-Maklai St., Moscow 117198, Russian Federation

The innovative development model for the Russian pharmaceutical industry provides for a transi-tion to international standards that are a basis for pharmaceutical manufacture and science. The production of medicines for veterinary use in Russia is a licensed activity and regulated by the federal laws and State Standards. Global drug designers and manufacturers are currently focused on the EU Guidelines for Good Manufacturing Practice (GMP) for Medicinal Products for Human and Veterinary Use. The paper comparatively analyzes the legal regulation of the manufacture of medicines for veterinary and medical uses during the transition towards the European system of norms, rules, and regulations in the production of drugs -- GMP. It also considers the imperfec-tions of this system, which cause difficulties under the current legislation of the Russian Federa-tion.
Keywords: 
medicines
pharmaceutical market
veterinary medicine
drug manufacture
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