11. 药物的规管

Q2 Social Sciences

Medical Law International Pub Date : 2019-08-01 DOI:10.1093/HE/9780198825845.003.0011

E. Jackson

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引用次数: 0

摘要

所有的书在这个旗舰系列包含精心挑选的关键案例，立法和学术辩论实质性摘录;为学生提供独立的资源。本章探讨药品的管理。它首先解释了什么是药品，以及在药品进入流通之前需要获得上市许可。它不仅涵盖了在许可之前确定安全性和有效性的重要性，而且还包括在许可之后通过药物警戒机制确定安全性和有效性的重要性。本章涵盖了欧洲对药品许可和营销规则的日益统一，并简要讨论了英国脱欧的影响。最后，它着眼于缺陷药品的责任，以及《消费者保护法》下的严格责任制度。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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11. The Regulation of Medicines

All books in this flagship series contain carefully selected substantial extracts from key cases, legislation, and academic debate; providing students with a stand-alone resource. This chapter examines the regulation of medicines. It first explains what a medicine is and the need for it to have a marketing authorization before it can be put into circulation. It covers the importance not only of establishing safety and efficacy before licensing, but afterwards as well, through pharmacovigilance mechanisms. The chapter covers the increasing European harmonization of the rules covering the licensing and marketing of medicines, and briefly discusses the implications of Brexit. Finally, it looks at liability for defective medicines, and the strict liability regime under the Consumer Protection Act.

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来源期刊

Medical Law International Social Sciences-Law

CiteScore

2.60

自引率

0.00%

发文量

期刊介绍： The scope includes: Clinical Negligence. Health Matters Affecting Civil Liberties. Forensic Medicine. Determination of Death. Organ and Tissue Transplantation. End of Life Decisions. Legal and Ethical Issues in Medical Treatment. Confidentiality. Access to Medical Records. Medical Complaints Procedures. Professional Discipline. Employment Law and Legal Issues within NHS. Resource Allocation in Health Care. Mental Health Law. Misuse of Drugs. Legal and Ethical Issues concerning Human Reproduction. Therapeutic Products. Medical Research. Cloning. Gene Therapy. Genetic Testing and Screening. And Related Topics.