Synonyms

Drug licensing; Medicines control; Medicines regulation Definition

The licensing and regulation of ► medicines in the United Kingdom is the statutory responsibility of their Medicines and Healthcare Products Regulatory Agency (MHRA), based in London. Before any medicine can be prescribed or sold in the UK it must have a marketing authorization (previously known as a product license). The marketing authorization specifies precisely the ► summary of product characteristics (SPC), along with the labeling and package leaflet for the product. The regulation of medicines, and the overall responsibilities of the MHRA, involves considerably more than a "once only'' marketing authorization. Regulation also entails post-licensing surveillance of safety and scrutiny of any proposed variation to the clinical indications for the medicine, any changes in availability, the on-going quality of the production process, and the enforcement of regulations when required, all in respect of the Agency's principal aim, which is to safeguard the public health. Marketing authorization is given or refused on the grounds of safety, quality, and efficacy. Financial cost plays no part in regulatory decisions.

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