| 000 | 02359nam a2200229Ia 4500 | ||
|---|---|---|---|
| 999 |
_c34111 _d34111 |
||
| 003 | OSt | ||
| 005 | 20210624125310.0 | ||
| 008 | 160316s2012 xxu||||| |||| 00| 0 eng d | ||
| 020 | _a9789041139016 | ||
| 040 | _cn | ||
| 082 |
_a344.042330 _bSHO |
||
| 100 | _aShorthose Sally | ||
| 245 | _aGuide EU pharmaceutical regulatory law | ||
| 250 | _a3rd | ||
| 260 |
_aThe Hague _bWolter Kluwer _c2012 |
||
| 300 |
_a640p _cxlix |
||
| 365 | _b Rs. 17,190 | ||
| 505 | _aAbout 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 | ||
| 650 | _a1. Drug Laws & Legislations - E U 2. Pharmaceutical Medicine - Law & Legislation3. Helath, Care Law - E U | ||
| 700 |
_aBird _aBird LLP |
||
| 942 |
_2ddc _cBK |
||