Medicines regulation in the United Kingdom.
Modern society seeks pharmaceutical products which are safe, effective and of good quality. Many health workers may be unfamiliar with the licensing system for human medicines which attempts to ensure that those goals are attained. In the United Kingdom the legislative framework to attain these objectives is the Medicines Act 1968, together with relevant European Community Directives. This paper briefly describes an outline of the licensing structure, explains the steps by which a new human medicine may reach the market and gives an indication of current licensing procedures by describing some considerations in the handling of an application for a product licence.
Watt
A H
AH
Scottish Home and Health Department, St Andrew's House, Edinburgh.
D007880:Legislation, Drug; D008004:Licensure / Q000331:legislation & jurisprudence; D011358:Product Surveillance, Postmarketing; D006113:United Kingdom