Research Handbook on EU Health Law and Policy
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Research Handbook on EU Health Law and Policy

Edited by Tamara K. Hervey, Calum A. Young and Louise E. Bishop

The steady expansion of the European Union’s involvement in health over the past 20 years has been accelerated by recent events. This handbook offers an up-to-date analytical overview of the most important topics in EU health law and policy. It outlines, as far as possible, the direction of travel for each topic and suggests research agenda(s) for the future.
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Chapter 7: EU law and policy on pharmaceuticals marketing and post-market control including product liability

Marcus Pilgerstorfer

Abstract

Marcus Pilgerstorfer considers how EU regulation and litigation based on EU health law interact in the case of pharmaceuticals, leaving uncertainties in the legal position with potential policy implications. The chapter considers some principal interactions between the EU’s regulatory regime for medicinal products, and its system of civil liability for defective products – focusing on marketing authorisation, labelling and advertising, post-market obligations and the Product Liability Directive.

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