The Law on Medicines: Volume 1 A Comprehensive Guide

The Medicines Act 1968 together with its delegated legislation comprehensively controls the manufacture, packaging, labelling, distribution and promotion of medicines for both human and animal use in the United Kingdom. It also controls the import and export of such medicines. It replaced a patchwork of controls which evolved over a century. Since its enactment, more than 150 items of delegated legislation (orders and regulations) have been made under its provisions and about 130 are still operative. The sheer physical bulk of this mass of material causes difficulty, not only in comprehension but also in finding the detail so often required. The situation is exacerbated by the fact that some pieces of legislation have been amended several times. My principal aim is to provide a reference book which contains all of the provisions of the Act and its various orders, regulations as amended to date. The material is arranged to facilitate the search for detail. In order to assist the reader in finding his way through this maze, Chaper 1 consists of a survey of the situation which existed before the Act came into being, together with a synopsis of the present controls. This should enable the reader to appreciate the changes which have occurred and how the system works.

Table of Contents:
1 Historical background and introduction.- 2 The administration of the Act.- 3 Medicinal products and other articles.- 4 The licensing system.- 5 Licences and certificates relating to products.- 6 Licences for activities.- 7 Controls over the sale and distribution of medicines.- 8 Wholesale sales.- 9 Retail sale of medicines for human use.- 10 Dispensing medicines.- 11 Sales, supplies and administration by exempted users.- 12 Herbal remedies.- 13 Homoeopathy and similar systems of medicine.- 14 Medicinal products for administration to animals.- 15 Medicated animal feeding stuffs.- 16 The packaging and labelling of medicines.- 17 The quality of medicinal products reaching the consumer.- 18 Promotion of sales of medicinal products.- 19 Advertisements and representations directed to practitioners.- 20 Advertisements directed to the public.- 21 Pharmacies.- Appendix 1: Definitions of words and phrases used in the Act and subordinate legislation.- Appendix 2: Recommended warning and advisory labels for dispensed medicines.- Appendix 3: Code of ethics of the Pharmaceutical Society of Great Britain.- Appendix 3B: Guide to good dispensing practice.- Appendix 3C: Guide to the self-assessment of professional practice activites.- Appendix 4: NHS limited list.