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Guide To EU Pharmaceutical Regulatory Law, 5th Edition

Guide To EU Pharmaceutical Regulatory Law, 5th Edition

Author: Sally Shorthose
Publisher: Kluwer Law International
ISBN: 9789041156099
Published In: November 2014
Format: Paperback , 712 pages
Jurisdiction: European Union ? Disclaimer:
Countri(es) stated herein are used as reference only

New Edition is available now !

Description
Contents

Details

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.

About the Editor and Authors.

Foreword.

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 Tasmina Goraya.

CHAPTER 6 Paediatrics Sally Shorthose & Sarah Faircliffe.

CHAPTER 7 Advertising Medicinal Products for Human Use Anne-Charlotte Le Bihan & Polina Lanckriet (Main Chapter, UK & France), Marc Martens & Nicolas Carbonnelle (Belgium), Ulf Grundmann (Germany), Hanneke Later-Nijland (Netherlands), Mauro Turrini (Italy), Ida Smed Sörensen & Mathilda Nordmark (Sweden) and Raquel Ballesteros & Lola Canalejo Rodriguez (Spain).

CHAPTER 8 Pharmacovigilance Sally Shorthose .

CHAPTER 9 Variations to Marketing Authorisations Tasmina Goraya.

CHAPTER 10 Combination Products Ina vom Feld.

CHAPTER 11 Abridged Procedure Hanneke Later-Nijland.

CHAPTER 12 Orphan Drugs 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 Kohoutek.

CHAPTER 17 Parallel Trade Ina vom Feld.

CHAPTER 18 Competition Law in the Pharmaceutical Sector José Rivas, Geoffroy van de Walle de Ghelcke & Carmen Feito Pérez.

Appendix Guidelines and Publications.