GT EU PHARMACEUTICAL REGULATOR

Guide to EU Pharmaceutical Regulatory Law

Seventh Edition

Edited by Sally Shorthose, Bird & Bird LLP

About the editor:

Sally joined Bird & Bird in September 2006 as a partner in the Intellectual Property Group, based in London. After studying Law at Manchester University and then at the College of Law, she completed her training at Herbert Smith and qualified in 1988. As a transactional intellectual property (IP) lawyer, she has been involved in providing advice in relation to the protection and exploitation of a full range of IP rights, from design rights to patents, trademarks, copyright and confidentiality across a range of jurisdictions. Sally is a regular speaker at conferences and seminars on a range of IP related subjects, particularly in relation to regulatory, licensing and exploitation matters.

About the book:

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