Full Description
European pharmaceutical law can be a minefield, due to the peculiarities of the European single market, the complexity of contemporary issues, and the rapid pace of scientific advancement. This book offers a comprehensive and in-depth analysis of EU pharmaceutical law, including expert perspectives on the most cutting-edge and contentious legal issues faced by the industry today. It provides analytical and informed discussion of legislation and jurisprudence relevant to the entire lifecycle of pharmaceutical and biopharmaceutical products. This is supported by case studies and incisive commentary to give a full understanding of the controversial policy considerations which shape interpretation of the law in practice. The legislation does not always provide answers, and the book adopts a creative approach which addresses both what the law says and what the law does not say.
Written by a team of experts in the field, Navigating European Pharmaceutical Law is an accessible guide for those new to the field, and an invaluable resource for experienced practitioners advising on critical and topical issues.
Contents
1. Introduction ; 2. Patent Protection for Pharmaceuticals and Biopharmaceutical Products ; 3. Clinical Trials ; 4. Procedures for Obtaining a Marketing Authorisation and Legal Bases for Application ; 5. Pricing, Reimbursement and Health Technology Appraisals ; 6. Paediatrics ; 7. Orphan Medicinal Products ; 8. Biologicals ; 9. Regulatory Data Protection ; 10. Supplementary Protection Certificates ; 11. The Maximisation of IP Regulatory Rights and Lifecycle Management Strategy ; 12. The interaction between Intellectual Property Law and Competition Law ; 13. Access to Information ; 14. Litigating decisions of the regulatory authorities ; 15. Pharmacovigilance ; 16. Data Protection ; 17. The Promotion of Medicinal Products in the EU ; 18. Borderline Products ; 19. Product Liability ; 20. Licensing Consideration ; 21. Parallel Trade and Stock Management Policies
