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Drug assessment: UK style

Abstract

Before medicines can be marketed in the UK, they are subject to a system of licensing and the granting of a marketing authorisation that describes the conditions and patient groups for which the medicinal product can be used within the terms of its licence.1 The licensing process involves an assessment of data relating to the efficacy, safety and quality of the product. However, the marketing authorisation does not determine whether, or how, it will be used in clinical practice. In the UK, the National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC) and the All Wales Medicines Strategy Group (AWMSG) publish recommendations on the use of medicines for health services in the United Kingdom. In this article we review their remit, work processes and the status of guidance published in England, Scotland, Wales and Northern Ireland.

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