Book contents
- Frontmatter
- Contents
- Contributors
- Editors' note for the first edition
- Editors' note for the second edition
- Foreword
- Table of statutes
- Table of cases
- 1 Legal institutions and the legal process
- 2 Human rights and healthcare professionals
- 3 Medical ethics and the forensic physician
- 4 Confidentiality
- 5 Consent to medical treatment
- 6 Professional bodies and discipline
- 7 Complaints in the National Health Service
- 8 The Mental Health Act (England and Wales)
- 9 Death certification and the role of the coroner
- 10 Tissues and organs
- 11 Organ donation
- 12 Living wills
- 13 Euthanasia and end-of-life decision-making
- 14 Abortion and reproductive health
- 15 The Children Act 1989
- 16 Clinical negligence
- 17 Legislation for medicines and product liability
- 18 Clinical trials: ethical, legal and practical considerations
- 19 Medicolegal implications of blood-borne viruses
- 20 Healthcare professionals in court – professional and expert witnesses
- Index
17 - Legislation for medicines and product liability
Published online by Cambridge University Press: 12 January 2010
- Frontmatter
- Contents
- Contributors
- Editors' note for the first edition
- Editors' note for the second edition
- Foreword
- Table of statutes
- Table of cases
- 1 Legal institutions and the legal process
- 2 Human rights and healthcare professionals
- 3 Medical ethics and the forensic physician
- 4 Confidentiality
- 5 Consent to medical treatment
- 6 Professional bodies and discipline
- 7 Complaints in the National Health Service
- 8 The Mental Health Act (England and Wales)
- 9 Death certification and the role of the coroner
- 10 Tissues and organs
- 11 Organ donation
- 12 Living wills
- 13 Euthanasia and end-of-life decision-making
- 14 Abortion and reproductive health
- 15 The Children Act 1989
- 16 Clinical negligence
- 17 Legislation for medicines and product liability
- 18 Clinical trials: ethical, legal and practical considerations
- 19 Medicolegal implications of blood-borne viruses
- 20 Healthcare professionals in court – professional and expert witnesses
- Index
Summary
INTRODUCTION
All medicines for human use are subject to stringent legislative controls before any product can be sold or supplied for use by health professionals and patients. The need for legislation to ensure that extensive testing of products is carried out before medicinal products are marketed was prompted by the teratogenic effects produced by thalidomide. The limb deformities produced by the drug would have been detected in the reproductive toxicology tests now routinely required during the drug development programme.
Today, medicinal products can only be supplied once their quality, safety, and efficacy have been assessed by the Licensing Authority and a marketing authorisation (previously called a product licence) has been issued. Current procedures by which a marketing authorisation is obtained are laid down in, primarily, European Union (EU) legislation. The legislation comprises Regulations, which are directly applicable in all Member States; Directives, which must be transposed into national legislation prior to implementation; and guidelines, which have no legal status, but which a manufacturer wishing to place a product on the market has to give good reasons for not following.
The complexity and scope of information that must be generated before in a marketing authorisation application can be submitted is shown in Table 17.1.
- Type
- Chapter
- Information
- Medicolegal Essentials in Healthcare , pp. 179 - 192Publisher: Cambridge University PressPrint publication year: 2004