This book examines European legislation that regulates the safety of consumer products. There are different legal requirements for medicines, machines, electronics, toys and so on, which employ different regulatory mechanisms. Hodges compares the various mechanisms and asks why particular mechanisms are used, or not used for different products. The book then moves on to consider what is meant by product 'safety', demonstrating the relativity of this concept.
This book examines European legislation that regulates the safety of consumer products. There are different legal requirements for medicines, machines, electronics, toys and so on, which employ different regulatory mechanisms. Hodges compares the various mechanisms and asks why particular mechanisms are used, or not used for different products. The book then moves on to consider what is meant by product 'safety', demonstrating the relativity of this concept.
Christopher Hodges is a Visiting Research Fellow at the Centre for Socio-Legal Studies, Oxford, and Partner at CMS Cameron McKenna.
Inhaltsangabe
* Table of Legislation * Table of Cases * List of Figures * List of Tables * List of Abbreviations * Introduction * 1: Theoretical aspects of regulation * Part One: Description of the main regulatory systems at Community level * 2: Introduction * 3: The limits on the Community's jurisdictional competence in product safety legislation * 4: Medicinal products * 5: New Approach products * 6: Biocides, cosmetics, tobacco, and general consumer products * Part Two: Procedural Mechanisms for safety * 7: Introduction * 8: Pre-market assessment: authorization to market * 9: Control of the manufacturing environment and process * 10: Providing information * 11: Producers' Post-marketing obligations * 12: The role of the authorities in post-marketing safety * 13: Control of distribution * 14: Obligations on users * 15: Conclusions on safety mechanisms * Part Three: Theoretical issues and conclusions * 16: Introduction * 17: The Community institutions involved and their mechanisms of governance * 18: Safety and risk * 19: Conclusions * Appendices * Appendix 1: The Pharmacovigilance System * Appendix 2: Statistics on the safety of general consumer products * Appendix 3: Statistics on the safety of medicinal products * Appendix 4: Statistics on the safety of electrical products * Appendix 5: Modules for conformity assessment procedures under the New Approach * Bibliography * Index
* Table of Legislation * Table of Cases * List of Figures * List of Tables * List of Abbreviations * Introduction * 1: Theoretical aspects of regulation * Part One: Description of the main regulatory systems at Community level * 2: Introduction * 3: The limits on the Community's jurisdictional competence in product safety legislation * 4: Medicinal products * 5: New Approach products * 6: Biocides, cosmetics, tobacco, and general consumer products * Part Two: Procedural Mechanisms for safety * 7: Introduction * 8: Pre-market assessment: authorization to market * 9: Control of the manufacturing environment and process * 10: Providing information * 11: Producers' Post-marketing obligations * 12: The role of the authorities in post-marketing safety * 13: Control of distribution * 14: Obligations on users * 15: Conclusions on safety mechanisms * Part Three: Theoretical issues and conclusions * 16: Introduction * 17: The Community institutions involved and their mechanisms of governance * 18: Safety and risk * 19: Conclusions * Appendices * Appendix 1: The Pharmacovigilance System * Appendix 2: Statistics on the safety of general consumer products * Appendix 3: Statistics on the safety of medicinal products * Appendix 4: Statistics on the safety of electrical products * Appendix 5: Modules for conformity assessment procedures under the New Approach * Bibliography * Index
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