| Titre : |
Guide to EU and UK Pharmaceutical Regulatory Law |
| Type de document : |
texte imprimé |
| Auteurs : |
SHORTHOSE, Sally, Auteur |
| Editeur : |
Wolters Kluwer |
| Année de publication : |
2023 |
| Importance : |
920 pages |
| ISBN/ISSN/EAN : |
978-94-035-3025-3 |
| Langues : |
Anglais (eng) |
| Catégories : |
Droit de la santé, droit pharmaceutique, droit de la personne et du corps humain
Droit européen
|
| Résumé : |
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.
Preface
CHAPTER 1
Brexit - Sally Shorthose
CHAPTER 2
Overview of European Pharmaceutical Regulatory Requirements - Sally Shorthose
CHAPTER 3
Overview of Intellectual Property Rights - Sally Shorthose, Marta Sznajder & Jonathan Edwards
CHAPTER 4
Clinical Trials - Sally Shorthose, Pieter Erasmus, Hester Borgers, Edzard Boonen & Anna Koster
CHAPTER 5
Obtaining a Marketing Authorisation - Sally Shorthose, Sarah Faircliffe & Phillipus Putter
CHAPTER 6
Conditional Marketing Authorisations - Sally Shorthose & Jonathan Edwards
CHAPTER 7
Supplementary Protection Certificates - Marta Sznajder & Jonathan Edwards
CHAPTER 8
Paediatrics - Sally Shorthose, Sarah Faircliffe & Pieter Erasmus
CHAPTER 9
Advertising Medicinal Products for Human Use - Hester Borgers & Edzard Boonen (main chapter, the Netherlands); Marc Martens & Benedicte Mourisse (Belgium); Alexandre Vuchot, Johanna Harelimana & Nour Saab (France); Christian Lindenthal & Wolfgang Ernst (Germany); Mauro Turrini (Italy); Coral Yáñez & Ana MarÃa Sánchez-Valdepeñas López (Spain); Gabriel Lidman & Gunnar Hjalt (Sweden); and Sally Shorthose, Sarah Faircliffe & Pieter Erasmus (United Kingdom)
CHAPTER 10
Pharmacovigilance - Sally Shorthose, Alexandre Vuchot, Pieter Erasmus, Johanna Harelimana & Nour Saab
CHAPTER 11
Variations to Marketing Authorisations - Alexandre Vuchot, Johanna Harelimana, Nour Saab & Phillipus Putter
CHAPTER 12
Combination Products - Sarah Faircliffe
CHAPTER 13
Abridged Procedure - Pieter Erasmus
CHAPTER 14
Orphan Medicinal Products - Sarah Faircliffe & Pieter Erasmus
CHAPTER 15
Biopharmaceuticals - Marc Martens, Benedicte Mourisse & Sophie Vo
CHAPTER 16
Homeopathic, Herbal, and Traditional Herbal Medicinal Products and Cannabis-Based Medicinal Products - Pieter Erasmus
CHAPTER 17
Advanced Therapy Medicinal Products - Marc Martens, Benedicte Mourisse & Sophie Vo
CHAPTER 18
Vaccines - Marc Martens & Phillipus Putter
CHAPTER 19
Medical Devices - Kevin Munungu & Sophie Vo
CHAPTER 20
Parallel Trade - Christian Lindenthal, Pieter Erasmus & Jonathan Edwards
CHAPTER 21
Competition Law in the Pharmaceutical Sector - Morten Nissen, Peter Willis & Alexander Brøchner
CHAPTER 22
Pandemics and Epidemics - Hester Borgers, Fenna Douwenga, Edzard Boonen & Phillipus Putter
CHAPTER 23
Data Protection in the Pharmaceutical Sector - Clara Clark Nevola & Emma Drake |
Guide to EU and UK Pharmaceutical Regulatory Law [texte imprimé] / SHORTHOSE, Sally, Auteur . - Wolters Kluwer, 2023 . - 920 pages. ISBN : 978-94-035-3025-3 Langues : Anglais ( eng)
| Catégories : |
Droit de la santé, droit pharmaceutique, droit de la personne et du corps humain
Droit européen
|
| Résumé : |
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.
Preface
CHAPTER 1
Brexit - Sally Shorthose
CHAPTER 2
Overview of European Pharmaceutical Regulatory Requirements - Sally Shorthose
CHAPTER 3
Overview of Intellectual Property Rights - Sally Shorthose, Marta Sznajder & Jonathan Edwards
CHAPTER 4
Clinical Trials - Sally Shorthose, Pieter Erasmus, Hester Borgers, Edzard Boonen & Anna Koster
CHAPTER 5
Obtaining a Marketing Authorisation - Sally Shorthose, Sarah Faircliffe & Phillipus Putter
CHAPTER 6
Conditional Marketing Authorisations - Sally Shorthose & Jonathan Edwards
CHAPTER 7
Supplementary Protection Certificates - Marta Sznajder & Jonathan Edwards
CHAPTER 8
Paediatrics - Sally Shorthose, Sarah Faircliffe & Pieter Erasmus
CHAPTER 9
Advertising Medicinal Products for Human Use - Hester Borgers & Edzard Boonen (main chapter, the Netherlands); Marc Martens & Benedicte Mourisse (Belgium); Alexandre Vuchot, Johanna Harelimana & Nour Saab (France); Christian Lindenthal & Wolfgang Ernst (Germany); Mauro Turrini (Italy); Coral Yáñez & Ana MarÃa Sánchez-Valdepeñas López (Spain); Gabriel Lidman & Gunnar Hjalt (Sweden); and Sally Shorthose, Sarah Faircliffe & Pieter Erasmus (United Kingdom)
CHAPTER 10
Pharmacovigilance - Sally Shorthose, Alexandre Vuchot, Pieter Erasmus, Johanna Harelimana & Nour Saab
CHAPTER 11
Variations to Marketing Authorisations - Alexandre Vuchot, Johanna Harelimana, Nour Saab & Phillipus Putter
CHAPTER 12
Combination Products - Sarah Faircliffe
CHAPTER 13
Abridged Procedure - Pieter Erasmus
CHAPTER 14
Orphan Medicinal Products - Sarah Faircliffe & Pieter Erasmus
CHAPTER 15
Biopharmaceuticals - Marc Martens, Benedicte Mourisse & Sophie Vo
CHAPTER 16
Homeopathic, Herbal, and Traditional Herbal Medicinal Products and Cannabis-Based Medicinal Products - Pieter Erasmus
CHAPTER 17
Advanced Therapy Medicinal Products - Marc Martens, Benedicte Mourisse & Sophie Vo
CHAPTER 18
Vaccines - Marc Martens & Phillipus Putter
CHAPTER 19
Medical Devices - Kevin Munungu & Sophie Vo
CHAPTER 20
Parallel Trade - Christian Lindenthal, Pieter Erasmus & Jonathan Edwards
CHAPTER 21
Competition Law in the Pharmaceutical Sector - Morten Nissen, Peter Willis & Alexander Brøchner
CHAPTER 22
Pandemics and Epidemics - Hester Borgers, Fenna Douwenga, Edzard Boonen & Phillipus Putter
CHAPTER 23
Data Protection in the Pharmaceutical Sector - Clara Clark Nevola & Emma Drake |
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Guide to EU and UK Pharmaceutical Regulatory Law
