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Guide To EU Pharmaceutical Regulatory Law, 8th Edition

Guide To EU Pharmaceutical Regulatory Law, 8th Edition

Author: Sally Shorthose
Publisher: Kluwer Law International
ISBN: 9789403530253
Published In: January 2023
Format: Hardback , 832 pages
Jurisdiction: European Union ? Disclaimer:
Countri(es) stated herein are used as reference only

List Price: HKD 2,400.00

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Description
Contents

Details
About this book:

Guide to EU and UK Pharmaceutical Regulatory Law is a unique volume that provides up-to-date information on the processes, legislation, cases, and customs that apply to the introduction, marketing, and sale of a medicinal product (or a medical device) in Europe. Competition law has always been crucial to the pharmaceutical sector since the industry is highly competitive and involves many intellectual property rights. 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 such essential products are not only efficacious but also safe.

What’s in this book:

Following a brief overview of how the exit from the EU by the UK currently affects the regulatory regime, as well as an introductory overview focusing on the regulatory framework for pharmaceuticals in Europe, each of the following twenty-one incisive chapters, examines a particular process or subject from an EU and UK-wide perspective. Among the many topics and issues covered 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’;
- homeopathic, 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.
In addition, at the end of each chapter, a list of guidelines/publications has been included that will direct the readers to sources of additional information.

How this will help you:

Dealing primarily with the European level of legislation, the book 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. This distinctive book will be of high relevance to pharmaceutical lawyers and regulatory advisers, both in-house and in private practice.
About the Editor and Authors

Foreword

List of Abbreviations

Brexit

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

Directives

Other Legislation

Regulations

Index