Chapter 17. Regulation of Human Medicinal Products in the European Union
- John P Griffin BSc, PhD, MBBS, FRCP, FRCPath, FFPM1,
- John O'Grady MD, FRCP, FFPM, FBIRA, MRCPath2
Published Online: 25 OCT 2007
DOI: 10.1002/9780470987391.ch17
© 2006 by Blackwell Publishing Ltd.
Book Title
The Textbook of Pharmaceutical Medicine, Fifth Edition
Additional Information
How to Cite
Shah, R. R. and Griffin, J. P. (2007) Regulation of Human Medicinal Products in the European Union, in The Textbook of Pharmaceutical Medicine, Fifth Edition (eds J. P. Griffin and J. O'Grady), Blackwell Publishing Ltd, Oxford, UK. doi: 10.1002/9780470987391.ch17
Editor Information
- 1
Director, Asklepieion Consultancy Ltd., Visiting Professor, University of Surrey Postgraduate Medical School, Former Director, Association of the British Pharmaceutical Industry, London, Formerly Professional Head of the Medicines Division, DHSS, London
- 2
Visiting Professor of Clinical Pharmacology, University of London
Publication History
- Published Online: 25 OCT 2007
- Published Print: 15 DEC 2005
ISBN Information
Print ISBN: 9780727918406
Online ISBN: 9780470987391
- Summary
- Chapter
- References
Keywords:
- medicinal products;
- pharmaceutical regulation;
- pharmaceutical legislation;
- committee for proprietary medicinal products;
- european union
Summary
This chapter contains sections titled:
Introduction
Regulatory Controls in the European Union
Procedures for Clinical Trials
Applications for Marketing Authorisations in the European Union
Integrated Regulatory Assessment
Medicines for Paediatric Use
Scientific Advice and Protocol Assistance
Procedures for Marketing Authorisation Applications
Applications for Orphan Designation
Sale and Supply of Human Medicines
Communications
Pharmacovigilance
Referrals to and Arbitration by CHMP
Summary of Product Characteristics
Regulatory Activities under National Authorities