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.
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