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This book is now Out of Print.
A new edition has been published, the details can be seen here:
Guide To EU Pharmaceutical Regulatory Law 6th ed isbn 9789041166388

Guide To EU Pharmaceutical Regulatory Law 2014 5th Edition

Edited by: Sally Shorthose

ISBN13: 9789041156099
New Edition ISBN: 9789041166388
Previous Edition ISBN: 9789041147905
Published: November 2014
Publisher: Kluwer Law International
Country of Publication: The Netherlands
Format: Paperback
Price: Out of print

In the European Union and its Member States, as elsewhere, the marketing of pharmaceuticals has become subject to an increasingly complex web of legislation and regulation, resulting from the intense scrutiny necessary to ensure such essential products are not only efficacious but safe.

This useful volume, now in its 5th edition for 2014, lays out this system with extraordinary clarity and logic. Adopting a Europe-wide perspective on the law governing pharmaceuticals, expert authors from the law firm Bird & Bird LLP map the life cycle of a medicinal product or medical device from development to clinical trials to product launch and ongoing pharmacovigilance, offering comprehensive and unambiguous guidance at every stage.

Following an introductory overview focusing on the regulatory framework for pharmaceuticals in Europe – from its underlying rationales to the relevant committees and agencies – each of fifteen incisive chapters examines a particular process or subject. Among the many topics and issues covered are the following:-

  • obtaining a marketing authorisation;
  • stages and standards for creating a product dossier;
  • clinical trials;
  • how and when an abridged procedure can be used;
  • criteria for conditional marketing authorisations;
  • generic products and ‘essential similarity’;
  • paediatric use and the requisite additional trials;
  • biologicals and ‘biosimilars’;
  • homeopathic and herbal medicines;
  • reporting procedures;
  • pharmacovigilance;
  • parallel trade;
  • relevant competition law and intellectual property rights; and
  • advertising.
In addition, national variation charts in many of the chapters illustrate eight major jurisdictions (Belgium, France, Germany, Italy, The Netherlands, Spain, Sweden, and the UK). Sample forms and URLs for the most important Directives are included.

Pharmaceutical lawyers and regulatory advisers, both in-house and in private practice, will welcome this unique book. It offers immeasurable value for all who need to understand the process of bringing a medicinal product or medical device to market and the continuing rights and obligations.

Medical Law
About the Editor and Authors.
List of Terms and Abbreviations.

CHAPTER 1 Overview of European Pharmaceutical Regulatory Requirements. Sally Shorthose.
CHAPTER 2 Clinical Trials.Sally Shorthose.
CHAPTER 3 Obtaining a Marketing Authorisation.Sally Shorthose & Sarah Faircliffe.
CHAPTER 4 Conditional Marketing Authorisations.Sally Shorthose.
CHAPTER 5 Supplementary Protection Certificates.Lorna Brazell.
CHAPTER 6 Paediatrics.Sally Shorthose & Sarah Faircliffe.
CHAPTER 7 Advertising Medicinal Products for Human Use.Mary Smillie (main chapter & UK), Marc Martens & Nicolas Carbonnelle (Belgium), Diane Bandon-Tourret (France), Ulf Grundmann & Elisabeth Kohoutek (Germany), Machteld Hiemstra (Netherlands), Mauro Turrini (Italy), Ida Smed Sörensen (Sweden) & Raquel Ballesteros (Spain).
CHAPTER 8 Pharmacovigilance.Sally Shorthose.
CHAPTER 9 Variations to Marketing Authorisations.Lorna Brazell.
CHAPTER 10 Combination Products.Ina vom Feld.
CHAPTER 11 Abridged Procedure.Sally Shorthose.
CHAPTER 12 Orphan Drug Protection.Sarah Faircliffe.
CHAPTER 13 Biologicals.Elizabeth Fuller.
CHAPTER 14 Homeopathic, Herbal, and Traditional Herbal Medicinal Products.Colette Mulder.
CHAPTER 15 Advanced Therapy Medicinal Products.Marc Martens & Nicolas Carbonnelle.
CHAPTER 16 Medical Devices.Ulf Grundmann & Elisabeth Kohoute k.
CHAPTER 17 Parallel Trade.Ina vom Feld.
CHAPTER 18 Competition Law in the Pharmaceutical Sector.José Rivas & Geoffroy van de Walle de Ghelcke.

APPENDIX 1 Useful Links.
APPENDIX 2 An Example of an SmPC – For Atenolol.
APPENDIX 3 An Example of a SUSAR Form.
APPENDIX 4 An Example of a Trial Protocol.
APPENDIX 5 Required Table of Contents for the Investigator’s Brochure.
Table of Cases.
Other Legislation.