About the Editor and Authors
Foreword;
List of Abbreviations Brexit;
CHAPTER 1 Overview of European Pharmaceutical Regulatory Requirements Sally Shorthose;
CHAPTER 2 Overview of Intellectual Property Rights Sally Shorthose & Tasmina Goraya;
CHAPTER 3 Clinical Trials Sally Shorthose;
CHAPTER 4 Obtaining a Marketing Authorisation Sally Shorthose & Sarah Faircliffe;
CHAPTER 5 Conditional Marketing Authorisations Sally Shorthose;
CHAPTER 6 Supplementary Protection Certificates Tasmina Goraya;
CHAPTER 7 Paediatrics Sally Shorthose & Sarah Faircliffe;
CHAPTER 8 Advertising Medicinal Products for Human Use Anne-Charlotte Le Bihan, Jean-Baptiste; Thiénot, Sally Shorthose, Sarah Faircliffe, Marc Martens, Nicolas Carbnnelle, Ulf Grundmann, Hanneke Later-Nijland, Mauro Turrini, Gabriel Lidman & Raquel Ballesteros;
CHAPTER 9 Pharmacovigilance Sally Shorthose;
CHAPTER 10 Variations to Marketing Authorisations Tasmina Goraya;
CHAPTER 11 Combination Products Sarah Faircliffe;
CHAPTER 12 Abridged Procedure Hanneke Later-Nijland;
CHAPTER 13 Orphan Drugs Sarah Faircliffe;
CHAPTER 14 Biopharmaceuticals Marc Martens & Nicolas Carbonnelle;
CHAPTER 15 Homeopathic, Herbal, and Traditional Herbal Medicinal Products Hanneke Later-Nijland;
CHAPTER 16 Advanced Therapy Medicinal Products Marc Martens & Nicolas Carbonnelle;
CHAPTER 17 Vaccines Raquel Ballesteros;
CHAPTER 18 Medical Devices Ulf Grundmann, Alexander Csaki, Clarissa Junge-Gierse & David Janiszewski;
CHAPTER 19 Parallel Trade Hanneke Later-Nijland;
CHAPTER 20 Competition Law in the Pharmaceutical Sector José Rivas & Silvia Pronk;
Appendix Guidelines and Publications Table of Cases;
Directives;
Other Legislation;
Regulations;
Index