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Guide To EU Pharmaceutical Regulatory Law, 3rd edition

Guide To EU Pharmaceutical Regulatory Law, 3rd edition

Author: Sally Shorthose; Bird & Bird LLP
Publisher: Kluwer Law International
ISBN: 9789041139016
Published In: July 2012
Format: Paperback , 696 pages
Jurisdiction: European Union ? Disclaimer:
Countri(es) stated herein are used as reference only

New Edition is available now !

Description
Contents

Details

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 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.

About the Editor and Authors

Foreword

List of Terms and Abbreviations

Chapter 1 Overview of European Pharmaceutical Regulatory Requirements

Sally Shorthose & Mary Smillie

Chapter 2 Obtaining a Marketing Authorisation

Sally Shorthose & Mary Smillie

Chapter 3 Pharmacovigilance

Mary Smillie

Chapter 4 Clinical Trials

Sally Shorthose

Chapter 5 Abridged Procedure

Sally Shorthose

Chapter 6 Conditional Marketing Authorisations

Sally Shorthose & Victoria Dearson

Chapter 7 Variations to Marketing Authorisations

Lorna Brazell

Chapter 8 Paediatrics

Sally Shorthose & Victoria Dearson

Chapter 9 Combination Products

Philipp Neels & Ina vom Feld

Chapter 10 Biologicals

Victoria Dearson

Chapter 11 Orphan Drug Protection

Victoria Dearson

Chapter 12 Homeopathic, Herbal, and Traditional Herbal Medicinal Products

Colette Mulder

Chapter 13 Medical Devices

Ulf Grundmann & Jarste Akkermann

Chapter 14 Parallel Trade

Ina vom Feld & Philipp Neels

Chapter 15 Competition Law in the Pharmaceutical Sector

Morten Nissen, Geoffroy van de Walle de Ghelcke & Melanie Vilarasau

Chapter 16 Advertising Medicinal Products for Human Use

Mary Smillie (main chapter & UK), Marc Martens & Nicolas Carbonnelle (Belgium), Diane Bandon-Tourret (France), Ulf Grundmann & Jarste Akkermann Germany), Machteld Hiemstra (Netherlands), Mauro Turrini (Italy) Ida Smed Sörensen (Sweden), Raquel Ballesteros (Spain)

Appendices

Appendix 1 Useful Links

Appendix 2 An Example of an SmPC–For Atenolol

Appendix 3 And 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

Directives

Other Legislation

Regulations