Chapter 3 Medicines law - an analysis of the Falsified Medicines Directive
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In Chapter 3, the legal perspective from the point of view of regulation of medicines is examined in context of the issues highlighted in the chapter on case studies. After establishing the legal basis and settling the question of competence of the EU in the sphere of Medicine law, the Falsified Medicines Directive (Directive 2011/62/EU) is analysed. The focus of the chapter is on provisions such as introduction of safety features to prevent falsification of medicines; measures to ensure the sanctity of the legal supply chain and provisions to protect the online sale of medicines. The role of organized crime and the presence of cross-border element is underlined. The main gaps that are deduced in the legal framework are discussed, and potential solutions to bridge the gaps are presented.

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