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Guide To EU Pharmaceutical Regulatory Law, Seventh Edition



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Guide to EU Pharmaceutical Regulatory Law, which is updated annually to reflect the speed at which the rules and regulations change, provides a comprehensive and practical guide to, and analysis of, the current European Union (EU) Pharmaceutical Regulatory Regime. In the EU 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 that such essential products are not only efficacious but also 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 product launch and ongoing pharmacovigilance, offering comprehensive and unambiguous guidance at every stage.

What’s in this book:

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 the 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 IP rights; and
  • advertising.

In addition, national variation charts in many of the chapters illustrate how the regime operates in the eight major jurisdictions (Belgium, France, Germany, Italy, The Netherlands, Spain, Sweden, and the UK). Sample forms and URLs for the most important Directives are also included. A brief overview of how the proposed exit from the EU by the UK will affect the regulatory regime is also included.

How this will help you:

Starting with an overview, this book primarily deals with how pharmaceutical products are brought to market from the conduct of clinical trials through amendments to marketing authorisations and abridged (generic) applications – the routes to obtaining a marketing authorisation covering special regimes such as the paediatric system and conditional marketing authorisations. Thus, this book serves as a guide for pharmaceutical lawyers and regulatory advisers, both in-house and in private practice, who need to understand the process of bringing a medicinal product or medical device to market and the continuing rights and obligations. In addition, this book also provides guidance on how ancillary subjects such as IP law, competition law, parallel imports and the regulation of homeopathic products influence pharmaceutical regime.

Pages 832
Last Updated 03/21/2017
Update Frequency As Needed
Product Line Kluwer Law International
ISBN 9789041169525
SKU 10059161-0001
Table of Contents

About the Editor and Authors


List of Abbreviations


CHAPTER 1 Overview of European Pharmaceutical Regulatory Requirements

Sally Shorthose

CHAPTER 2 Overview of Intellectual Property Rights

Sally Shorthose & Tasmina Goraya

CHAPTER 3 Clinical Trials

Sally Shorthose

CHAPTER 4 Obtaining a Marketing Authorisation

Sally Shorthose & Sarah Faircliffe

CHAPTER 5 Conditional Marketing Authorisations

Sally Shorthose

CHAPTER 6 Supplementary Protection Certificates

Tasmina Goraya

CHAPTER 7 Paediatrics

Sally Shorthose & Sarah Faircliffe

CHAPTER 8 Advertising Medicinal Products for Human Use

Anne-Charlotte Le Bihan, Jean-Baptiste Thiénot, Sally Shorthose, Sarah Faircliffe, Marc Martens, Nicolas Carbonnelle, Ulf Grundmann, Hanneke Later-Nijland, Mauro Turrini, Gabriel Lidman & Raquel Ballesteros

CHAPTER 9 Pharmacovigilance

Sally Shorthose

CHAPTER 10 Variations to Marketing Authorisations

Tasmina Goraya

CHAPTER 11 Combination Products

Sarah Faircliffe

CHAPTER 12 Abridged Procedure

Hanneke Later-Nijland

CHAPTER 13 Orphan Drugs

Sarah Faircliffe

CHAPTER 14 Biopharmaceuticals

Marc Martens & Nicolas Carbonnelle

CHAPTER 15 Homeopathic, Herbal, and Traditional Herbal Medicinal Products

Hanneke Later-Nijland

CHAPTER 16 Advanced Therapy Medicinal Products

Marc Martens & Nicolas Carbonnelle

CHAPTER 17 Vaccines

Raquel Ballesteros

CHAPTER 18 Medical Devices

Ulf Grundmann, Alexander Csaki, Clarissa Junge-Gierse & David Janiszewski

CHAPTER 19 Parallel Trade

Hanneke Later-Nijland

CHAPTER 20 Competition Law in the Pharmaceutical Sector

José Rivas & Silvia Pronk

Appendix Guidelines and Publications

Table of Cases


Other Legislation



About The Experts