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Guide to EU and UK Pharmaceutical Regulatory Law 9th ed

Guide to EU and UK Pharmaceutical Regulatory Law 9th ed

Author: Pieter Erasmus; Sally Shorthose
Publisher: Kluwer Law International
ISBN: 9789403511191

Previous Edition ISBN: 9789403530253
Published In: November 2025
Format: Hardback
Jurisdiction: Netherlands ? Disclaimer:
Countri(es) stated herein are used as reference only

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Description
Contents

Details

Guide to EU and UK Pharmaceutical Regulatory Law, currently in its ninth edition, is a useful book outlining this system with extraordinary clarity and logic. Embracing a Europe-wide perspective on the law governing pharmaceuticals, adept contributors 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. In the European Union (EU), its Member States and the United Kingdom (UK) post-Brexit, as elsewhere, the marketing of pharmaceuticals is subject to an ever more 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.

What’s in this book:

Succeeding the brief introductory chapters that provide an overview of the regulatory framework for pharmaceuticals in Europe, a short discussion of how the overarching EU regulatory regime is poised to change in the coming years, and how the exit from the EU by the UK currently affects the regulatory regime, each of the following (twenty-one) incisive chapters examines a particular process or subject. Among the many topics and issues covered from both an EU and UK perspective – including the all-new chapter on artificial intelligence – are the following:

clinical trials
stages and standards for creating a product dossier
obtaining a marketing authorisation
how and when an abridged marketing authorisation procedure can be used
criteria for conditional marketing authorisations
generic products and ‘essential similarity’
paediatric use and the requisite additional trials
orphan medicinal products;
biologicals and ‘biosimilars’;
homoeopathic, herbal and similar medicines;
medical devices
pandemics, epidemics and vaccines
pharmacovigilance
parallel trade
advertising, and
relevant competition law, intellectual property rights and data protection regulation

How this will help you:

This unique book will be highly appreciated by pharmaceutical lawyers and regulatory advisers, both in-house and in private practice. It will prove invaluable for all who need to understand the process of bringing a medicinal product or medical device to market and the continuing rights and obligations.

List of Abbreviations

Preface

Chapter 1 Overview of European Pharmaceutical Regulatory Requirements

Chapter 2 EU Pharma Package

Chapter 3 Brexit

Chapter 4 Overview of Intellectual Property Rights

Chapter 5 Clinical Trials

Chapter 6 Obtaining a Marketing Authorisation

Chapter 7 Conditional Marketing Authorisations

Chapter 8 Supplementary Protection Certificates

Chapter 9 Paediatrics

Chapter 10 Advertising Medicinal Products for Human Use