Guide To EU Pharmaceutical Regulatory Law, 8th Edition

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.