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European Regulation of Consumer Product Safety$
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Christopher Hodges

Print publication date: 2005

Print ISBN-13: 9780199282555

Published to Oxford Scholarship Online: March 2012

DOI: 10.1093/acprof:oso/9780199282555.001.0001

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PRINTED FROM OXFORD SCHOLARSHIP ONLINE (oxford.universitypressscholarship.com). (c) Copyright Oxford University Press, 2021. All Rights Reserved. An individual user may print out a PDF of a single chapter of a monograph in OSO for personal use. date: 27 July 2021

The Role of Authorities in Post-marketing Safety

The Role of Authorities in Post-marketing Safety

Chapter:
(p.155) 12 The Role of Authorities in Post-marketing Safety
Source:
European Regulation of Consumer Product Safety
Author(s):

Christopher Hodges

Publisher:
Oxford University Press
DOI:10.1093/acprof:oso/9780199282555.003.0012

The issue for this chapter is what the role of the authorities should be in achieving the safety of products in use after they have been put into circulation, and the extent to which they currently fulfil this role within the existing legislative framework. Classic regulatory theory is that a market requires a regulator so as to correct excessive behaviour by uncontrolled economic operators. For medicinal products, the Commission, the EMEA, and national authorities have continuing primary responsibility for the continued authorization for the marketing of products. The structure of this chapter is as follows. First, a framework of five core activities is suggested which, individually and collectively, would contribute to product safety, and which could be undertaken by competent authorities. The extent to which each activity is found in the vertical and horizontal legislation is then examined, and conclusions are drawn.

Keywords:   classic regulatory theory, Commission, EMEA, national authorities, product safety

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