"In the European Union 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 such essential products are not only efficacious but 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 clinical trials to product launch and ongoing pharmacovigilance, offering comprehensive and unambiguous guidance at every stage."-- Wolters Kluwer CCH Website.
Bibliography, etc. Note
Includes bibliographical references and index.
Formatted Contents Note
Chapter 1. Overview of European pharmaceutical regulatory requirements Chapter 2. Overview of intellectual property rights Chapter 3. Clinical trials Chapter 4. Obtaining a marketing authorisation Chapter 5. Conditional marketing authorisations Chapter 6. Supplementary protection certificates Chapter 7. Paediatrics Chapter 8. Advertising medicinal products for human use Chapter 9. Pharmacovigilance Chapter 10. Variations to marketing authorisations Chapter 11. Combination products Chapter 12. Abridged procedure Chapter 13. Orphan drugs Chapter 14. Biopharmaceuticals Chapter 15. Homeopathic, herbal, and traditional herbal medicinal products Chapter 16. Advanced therapy medicinal products Chapter 17. Vaccines Chapter 18. Medical devices Chapter 19. Parallel trade Chapter 20. Competition law in the pharmaceutical sector.
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Digital File Characteristics
Source of Description
Title from tile screen (viewed February 24, 2017).