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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

Medicinal Products

Medicinal Products

Chapter:
(p.38) 4 Medicinal Products
Source:
European Regulation of Consumer Product Safety
Author(s):

Christopher Hodges

Publisher:
Oxford University Press
DOI:10.1093/acprof:oso/9780199282555.003.0004

The Community's regulatory system for medicinal products comprises ‘a very substantial body of Community legislation and case law’. It has been amended regularly since the first Directive was introduced in 1965 as a response to the Thalidomide tragedy. The regulatory system for medicinal products comprises the following principal points. The person responsible for marketing a medicinal product within the Community must apply to a competent authority for, and be granted, a marketing authorization for the product. The application must be accompanied by, first, specified particulars and documents, which record the data generated from prescribed tests and trials on the product and, secondly, the written opinion of experts in analysis, pharmacology, and clinical medicine, who attest that the relevant tests have been carried out and that the results and the product offer the acceptable levels in relation to, respectively, manufacturing controls, toxicity, and clinical safety.

Keywords:   regulatory system, medicinal products, Thalidomide tragedy, pharmacology, clinical medicine

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