Guide to EU Pharmaceutical Regulatory Law

Sally Shorthose

Kluwer Law International, Fifth Edition - November 2014.

Fully revised and updated, this practical book contains information on the processes, legislation, cases and customs that apply to the introduction, marketing and sale of a medicinal product (or medicinal device) in Europe.

Pharmaceutical regulatory law is becoming ever more complicated, with the need to balance the constitutional requirements of the EU and its constituent Member States. This work, written by and for lawyers, will help you advise your clients on this constantly changing area.

The new edition provides you with information on the changes to clinical trials, pharmacovigilance and competition law, helping you stay abreast of new legislation.

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 clinical trials to product launch and ongoing pharmacovigilance, providing you with comprehensive and unambiguous guidance at every stage.

Comprising three main sections, you’ll find the mainstream medicinal products from cradle to grave; specific regimes which do not fall into those categories; and three standalone chapters, dealing with an overview of what a medical device is, parallel trade, and competition law.

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 15 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 intellectual property rights; and
  • advertising

Extra help

  • National variation charts in many of the chapters illustrate eight major jurisdictions (Belgium, France, Germany, Italy, The Netherlands, Spain, Sweden, and the UK)
  • Includes sample forms and URLs for the most important Directives

If you work as a pharmaceutical lawyer or regulatory adviser, whether in-house or in private practice, this unique book will help you understand the process of bringing a medicinal product or medical device to market and the continuing rights and obligations.

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