Правен режим на верификацията на лекарства в България и в Европейския съюз
Legal Regime of Medicine Verification in Bulgaria and European Union

Author(s): Lilia Monova-Asenova
Subject(s): Law, Constitution, Jurisprudence, Health and medicine and law, EU-Legislation
Published by: Пловдивски университет »Паисий Хилендарски«
Keywords: Directive; EU Regulation; Law on Medicinal Products in Human Medicine; verification.
Summary/Abstract: The protection of public health is one of the main benefits, both national and European level. The risk of increasing the threat of counterfeit medicines reaching the population of Bulgaria and the European Union (EU) has created a number of legislative changes in European and national legislation, as at present, the main means of patient protection is to be achieved through a system of activities related to the authentication of medicinal products offered on the territory of the European Union. The comprehensive system called medication verification comes into force and becomes mandatory for the whole of the EU from 9.02.2019, with the exception of three countries receiving an additional transitional period. The purpose of this scientific report is to present the legal regime of the system of activities related to drug verification, the statutory organizational and financial specifics of the participants in the process, as well as to identify and analyze potential problems and to propose alternative methods for solving them.

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