European Regulation of Medical Devices and Pharmaceuticals Regulatee
One of the primary functions of law is to ensure that the legal structure governing all social relations is predictable, coherent, consistent and applicable. Taken together, these characteristics of law are referred to as legal certainty. In traditional a
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European Regulation of Medical Devices and Pharmaceuticals Regulatee Expectations of Legal Certainty
European Regulation of Medical Devices and Pharmaceuticals
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Nupur Chowdhury
European Regulation of Medical Devices and Pharmaceuticals Regulatee Expectations of Legal Certainty
Nupur Chowdhury Department of Public Administration School of Management and Governance University of Twente Enschede The Netherlands
Previous versions of Chapters 2, 5 and 8 have been published in the following journals: Chowdhury/Wessel, ‘Conceptualizing Multilevel Regulation in the EU: A Legal Translation of Multilevel Governance?’ (2012) 18 European Law Journal 335–357; Chowdhury, ‘Common Market but divergent regulatory practices: Exploring European regulation and the effect on regulatory uncertainty in the marketing authorization of medical products’, (2013) 35 Journal of European Integration, 635–652.; Chowdhury, ‘Limits to the legal deliberation of science questions: A case study of borderline medical products in Europe’, (2012) 14 Pharmaceuticals Policy and Law 157–175.
ISBN 978-3-319-04593-1 ISBN 978-3-319-04594-8 (eBook) DOI 10.1007/978-3-319-04594-8 Springer Cham Heidelberg New York Dordrecht London Library of Congress Control Number: 2014937665 © Springer International Publishing Switzerland 2014 This work is subject to copyright. All rights are reserved by the Publisher, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. Exempted from this legal reservation are brief excerpts in connection with reviews or scholarly analysis or material supplied specifically for the purpose of being entered and executed on a computer system, for exclusive use by the purchaser of the work. Duplication of this publication or parts thereof is permitted only under the provisions of the Copyright Law of the Publisher’s location, in its current version, and permission for use must always be obtained from Springer. Permissions for use may be obtained through RightsLink at the Copyright Clearance Center. Violations are liable to prosecution under the respective Copyright Law. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. While the advice and information in this book are believed to be true and accurate at the date of publication, neither the authors nor the editors nor the publisher can accept any legal responsibility for any errors or omissions that may be made. The publisher makes no warranty, express or implied, with respect to the material contained herein.
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