Guide to EU Pharmaceutical Regulatory Law
Samenvatting
About this book:
Guide to EU and UK Pharmaceutical Regulatory Law is a unique volume that provides up-to-date information on the processes, legislation, cases, and customs that apply to the introduction, marketing, and sale of a medicinal product (or a medical device) in Europe. Competition law has always been crucial to the pharmaceutical sector since the industry is highly competitive and involves many intellectual property rights. In the European Union (EU), its Member States and the United Kingdom (UK) post-Brexit, as elsewhere, the marketing of pharmaceuticals is subject to an ever more complex web of legislation and regulation, resulting from the intense scrutiny necessary to ensure such essential products are not only efficacious but also safe.
What's in this book:
Following a brief overview of how the exit from the EU by the UK currently affects the regulatory regime, as well as an introductory overview focusing on the regulatory framework for pharmaceuticals in Europe, each of the following twenty-one incisive chapters, examines a particular process or subject from an EU and UK-wide perspective. Among the many topics and issues covered are the following:
- clinical trials;
- stages and standards for creating a product dossier;
- obtaining a marketing authorisation;
- how and when an abridged marketing authorisation procedure can be used;
- criteria for conditional marketing authorisations;
- generic products and ‘essential similarity';
- paediatric use and the requisite additional trials;
- orphan medicinal products;
- biologicals and ‘biosimilars';
- homeopathic, herbal and similar medicines;
- medical devices;
- pandemics, epidemics and vaccines;
- pharmacovigilance;
- parallel trade;
- advertising; and
- relevant competition law, intellectual property rights and data protection regulation.
In addition, at the end of each chapter, a list of guidelines/publications has been included that will direct the readers to sources of additional information.
How this will help you:
Dealing primarily with the European level of legislation, the book 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 obligations. This distinctive book will be of high relevance to pharmaceutical lawyers and regulatory advisers, both in-house and in private practice.
Specificaties
Inhoudsopgave
Foreword
List of Abbreviations
Brexit
CHAPTER 1
Overview of European Pharmaceutical Regulatory Requirements
Sally Shorthose
CHAPTER 2
Overview of Intellectual Property Rights
Sally Shorthose, Marta Sznajder & Jonathan Edwards
CHAPTER 3
Clinical Trials
Sally Shorthose, Pieter Erasmus, Hester Borgers & Edzard Boonen
CHAPTER 4
Obtaining a Marketing Authorisation
Sally Shorthose, Sarah Faircliffe & Phillipus Putter
CHAPTER 5
Conditional Marketing Authorisations
Sally Shorthose & Jonathan Edwards
CHAPTER 6
Supplementary Protection Certificates
Marta Sznajder & Jonathan Edwards
CHAPTER 7
Paediatrics
Sally Shorthose, Sarah Faircliffe & Pieter Erasmus
CHAPTER 8
Advertising Medicinal Products for Human Use
Hester Borgers & Edzard Boonen (main Chapter, the Netherlands); Marc Martens & Benedicte Mourisee (Belgium); Alexandre Vuchot & Johanna Harelimana (France); Wolfgang Ernst (Germany); Mauro Turrini (Italy); Coral Yáñez & Ana María Sánchez-Valdepeñas López (Spain); Gabriel Lidman & Gunnar Hjalt (Sweden); and Sally Shorthose, Sarah Faircliffe & Pieter Erasmus (United Kingdom)
CHAPTER 9
Pharmacovigilance
Sally Shorthose, Alexandre Vuchot, Pieter Erasmus & Johanna Harelimana
CHAPTER 10
Variations to Marketing Authorisations
Alexandre Vuchot, Johanna Harelimana & Phillipus Putter
CHAPTER 11
Combination Products
Sarah Faircliffe
CHAPTER 12
Abridged Procedure
Pieter Erasmus
CHAPTER 13
Orphan Medicinal Products
Sarah Faircliffe & Pieter Erasmus
CHAPTER 14
Biopharmaceuticals
Marc Martens, Benedicte Mourisse & Sophie Vo
CHAPTER 15
Homeopathic, Herbal and Traditional Herbal Medicinal Products and Cannabis-based Medicinal Products
Pieter Erasmus
CHAPTER 16
Advanced Therapy Medicinal Products
Marc Martens, Benedicte Mourisse & Sophie Vo
CHAPTER 17
Vaccines
Marc Martens & Phillipus Putter
CHAPTER 18
Medical Devices
Kevin Munungu & Sophie Vo
CHAPTER 19
Parallel Trade
Christian Lindenthal, Pieter Erasmus & Jonathan Edwards
CHAPTER 20
Competition Law in the Pharmaceutical Sector
Morten Nissen, Peter Willis & Alexander Brøchner
CHAPTER 21
Pandemics and Epidemics
Hester Borgers, Fenna Douwenga, Edzard Boonen & Phillipus Putter
CHAPTER 22
Data Protection in the Pharmaceutical Sector
Clara Clark Nevola & Emma Drake
Appendix Guidelines and Publications
Table of Cases
Directives
Other Legislation
Regulations
Index
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