Guide to EU Pharmaceutical Regulatory Law

Edited by Sally Shorthose and contributed to by:
Raquel Ballesteros; Colette Mulder; Ina vom Feld; Philipp Neels; Ulf Grundmann; Jarste Akkermann; Mary Smillie; Victoria Evans; Morten Nissen; Mauro Turrini; Alain Gorny; Sara Sparring, Gina Brueton.

Kluwer Law International’s Guide to EU Pharmaceutical Regulatory Law is a unique reference that follows the complete life cycle of a medicinal product or medical device and provides clear guidance throughout the complicated regulatory process. Knowing that EU legislation can at times be at odds with local standards, the authors have included national variation charts at the end of certain chapters, highlighting significant deviations or differences of interpretation for a number of major jurisdictions:

  • UK

  • France

  • Germany

  • Spain

  • Belgium

  • Italy

  • Spain

  • Sweden

  • The Netherlands

In addition, Kluwer Law International will update twice a year covering new legislation and cases, ensuring you are always up-to-date and able to advise with confidence.

Here’s just a sample of what you’ll find in Guide to EU Pharmaceutical Regulatory Law

  • an introduction to the regulatory framework and relevant committees and agencies;

  • an outline of the requirements and routes for obtaining a Marketing Authorisation;

  • a discussion of pharmacovigiliance, with particular emphasis on the reporting procedures regarding adverse events;

  • a detailed analysis of clinical trials, the Clinical Trials Directive, and stages and standards for creating a product dossier;

  • guidance on when the abridged Marketing Authorisation procedure can be used, generic products and essential similarity;

  • understanding supplemental obligations, such as the need for additional clinical trials of the product for paediatric use;

  • how to introduce biological medicinal products or biosimilars;

  • details on increased regulation and scrutiny of the sale and use of homeopathic and herbal medicines;
    an overview of parallel trade;

  • relevant competition law and intellectual property rights pertaining to the pharmaceutical industry;
    complete coverage of European and local legislation in the area of advertising and the sale of medicinal products and medical devices.

See also:
Guide to EU Pharmaceutical Regulatory Law - 2nd Edition
Guide to EU Pharmaceutical Regulatory Law - 3rd Edition

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