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.