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Guide to EU Pharmaceutical Regulatory Law -4th edition

Editor: Sally Shorthose, Bird & Bird LLP

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...

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pdf 'Table of Cases' (2012), Sally Shorthose, pp. 609–618
pdf 'Directives' (2012), Sally Shorthose, pp. 619–622
pdf 'Other Legislation' (2012), Sally Shorthose, pp. 623–624
pdf 'Regulations' (2012), Sally Shorthose, pp. 625–628
pdf 'Index' (2012), Sally Shorthose, pp. 629–640
icon acrobat readerFull chapter About the Editor and Authors
pdf 'About the Editor and Authors' (2012), Ida Smed Sörensen, Sara Sparring, Raquel Ballesteros, Mauro Turrini, Laure Dusart, Diane Bandon-Tourret, Alain Gorny, Nicolas Carbonnelle, Marc Martens, Geoffroy van de Walle de Ghelcke, Melanie Vilarasau, Ina vom Feld, Jarste Akkermann, Ulf Grundmann, Colette Mulder, Philipp Neels, Victoria Evans, Machteld Hiemstra, Gina Brueton, Lorna Brazell, Mary Smillie, Sally Shorthose, pp. v–xviii
pdf 'Table of Contents' (2012), Sally Shorthose, pp. xxvii–xlviii
Foreword
pdf 'Foreword' (2012), Sally Shorthose, pp. xix–xxii
List of Terms and Abbreviations
pdf 'List of Terms and Abbreviations' (2012), Sally Shorthose, pp. xlix–lii
icon acrobat readerFull chapter Chapters
pdf 'Chapter 1 Overview of European Pharmaceutical Regulatory Requirements' (2012), Sally Shorthose, Mary Smillie, pp. 1–26
pdf 'Chapter 2 Clinical Trials' (2012), Sally Shorthose, pp. 27–102
pdf 'Chapter 3 Obtaining a Marketing Authorization' (2012), Mary Smillie, Sally Shorthose, pp. 103–138
pdf 'Chapter 4 Conditional Marketing Authorizations' (2012), Sally Shorthose, pp. 139–152
pdf 'Chapter 5 Supplementary Protection Certificates' (2012), Lorna Brazell, pp. 153–168
pdf 'Chapter 6 Paediatrics' (2012), Sally Shorthose, Sarah Faircliffe, pp. 169–192
pdf 'Chapter 7 Advertising Medicinal Products for Human Use' (2012), Mary Smillie, Marc Martens, Nicolas Carbonnelle, Diane Bandon-Tourret, Jarste Akkermann, Ulf Grundmann, Machteld Hiemstra, Mauro Turrini, Ida Smed Sörensen, Raquel Ballesteros, pp. 193–264
pdf 'Chapter 8 Pharmacovigilance' (2012), Mary Smillie, pp. 265–314
pdf 'Chapter 9 Variations to Marketing Authorizations' (2012), Lorna Brazell, pp. 315–330
pdf 'Chapter 10 Combination Products' (2012), Philipp Neels, Ina vom Feld, pp. 331–348
pdf 'Chapter 11 Abridged Procedure' (2012), Sally Shorthose, pp. 349–376
pdf 'Chapter 12 Orphan Drug Protection' (2012), Sarah Faircliffe, pp. 377–402
pdf 'Chapter 13 Biologicals' (2012), Elizabeth Fuller, pp. 403–428
pdf 'Chapter 14 Homeopathic, Herbal, and Traditional Herbal Medicinal Products' (2012), Colette Mulder, pp. 429–448
pdf 'Chapter 15 Advanced Therapy Medicinal Products' (2012), Marc Martens, Nicolas Carbonnelle, pp. 449–462
pdf 'Chapter 16 Medical Devices' (2012), Jarste Akkermann, Ulf Grundmann, pp. 463–506
pdf 'Chapter 17 Parallel Trade' (2012), Ina vom Feld, Philipp Neels, pp. 507–540
pdf 'Chapter 18 Competition Law in the Pharmaceutical Sector' (2012), Morten Nissen, Geoffroy van de Walle de Ghelcke, Melanie Vilarasau, pp. 541–568
icon acrobat readerFull chapter Appendices
pdf 'Appendix 1 Useful Links' (2012), Sally Shorthose, pp. 571–572
pdf 'Appendix 2 An Example of an SmPC – For Atenolol' (2012), Sally Shorthose, pp. 573–580
pdf 'Appendix 3 An Example of a SUSAR Form' (2012), Sally Shorthose, pp. 581–588
pdf 'Appendix 4 An Example of a Trial Protocol' (2012), Sally Shorthose, pp. 589–606
pdf 'Appendix 5 Required Table of Contents for the Investigators Brochure' (2012), Sally Shorthose, pp. 607–608
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