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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 titles 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. Following an introductory overview
focusing on the regulatory framework for pharmaceuticals in Europe – from its
underlying rationales to the relevant committees and agencies – each of
fifteen incisive chapters examines a particular process or subject.
Among the many topics and issues covered are the following:
obtaining a marketing authorisation;
stages and standards for creating a product dossier;
how and when an abridged procedure can be used;
criteria for conditional marketing authorisations;
generic products and ‘essential similarity’;
paediatric use and the requisite additional trials;
biologicals and ‘biosimilars’;
homeopathic and herbal medicines;
relevant competition law and intellectual property rights; and
In addition, national variation charts in many of the chapters illustrate
eight major jurisdictions Belgium, France, Germany, Italy, The Netherlands,
Spain, Sweden, and the UK). Sample forms and URLs for the most important
Directives are included. Pharmaceutical lawyers and regulatory advisers, both
in-house and in private practice, will welcome this unique titles. It offers
immeasurable value for all who need to understand the process of bringing a
medicinal product or medical device to market and the continuing rights and
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About the Editor and Authors. Foreword. List of Terms and Abbreviations.
Chapter 1 Overview of European Pharmaceutical Regulatory Requirements
Sally Shorthose & Mary Smillie. Chapter 2 Clinical Trials
Sally Shorthose. Chapter 3 Obtaining Marketing Authorisations
Sally Shorthose & Mary Smillie. Chapter 4 Conditional Marketing
Authorisations Sally Shorthose & Mary Smillie. Chapter 5
Supplementary Protection Certificates Lorna Brazell. Chapter 6
Paediatrics Sally Shorthose & Sarah Faircliffe. Chapter 7
Advertising Medicinal Products for Human Use Mary Smillie (main chapter &
UK), Marc Martens & Nicolas Carbonnelle (Belgium), Diane Bandon-Tourret
(France), Ulf Grundmann & Jarste Akkermann (Germany), Machteld Hiemstra
(Netherlands), Mauro Turrini (Italy) Ida Smed Sörensen (Sweden), Raquel
Ballesteros (Spain). Chapter 8 Pharmacovigilance Mary Smillie
. Chapter 9 Variations to Marketing Authorisations Lorna Brazell
. Chapter 10 Combination Products Philip Neels & Ina vom Feld.
Chapter 11 Abridged Procedure Sally Shorthose. Chapter 12
Orphan Drug Protection Sarah Faircliffe. Chapter 13 Biologicals
Liz Fuller. Chapter 14 Homeopathic, Herbal, and Traditional Herbal
Medicinal Products Colette Mulder. Chapter 15 ATMP Regulations
Mac Martens & Nicolas Carbonnelle. Chapter 16 Medical Devices
Jarste Akkermann & Ulf Grundmann. Chapter 17 Parallel Trade
Ina vom Feld & Philipp Neels. Chapter 18 Competition Law in the
Pharmaceutical Sector Morten Nissen, Geoffrey van de Walle de Ghelcke &
Melanie Vilarasau. Appendices. Appendix 1 Useful Links.
Appendix 2 An Example of an SmPC–For Atenolol. Appendix 3 And
Example of a SUSAR Form. Appendix 4 An Example of a Trial Protocol.
Appendix 5 Required Table of Contents for the Investigator’s Brochure.
Table of Cases. Directives. Other Legislation. Regulations.