This briefing outlines both the process for licensing a new medicine in the UK (Part 1) and the process for issuing guidance and advice to the NHS in Scotland on its use (Part 2). It describes the role of the various bodies involved at a Scottish and UK level. It also provides information on the pricing of medicines and the operation of risk sharing schemes for specialised medicines (Part 3). It should be noted that this briefing does not cover the licensing of medical devices, which operates under a separate system.
This briefing is an update to, and supercedes, Briefing SB 08-17: ‘Licensing of Medicines in the UK and their Use in the NHS’.
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Published: 23 August 2012