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The use of off-label or unlicensed medicines in the UK

The use of off-label or unlicensed medicines in the UK

Download a printable PDF of this module – including the five-minute test – here.

From this module, you will learn about:

  • The difference between unlicensed and off-label medicine use
  • When medicines can be used unlicensed and off-label
  • The risks associated with using medicines unlicensed or off-label
  • How pharmacy teams can provide advice to those taking unlicensed or off-label medicines
Take the exam

For a medicinal product to be licensed in the UK, a marketing authorisation is required via the Medicines and Healthcare product Regulatory Agency (MHRA). A marketing authorisation defines the terms in which a medicine can be used (known as the ‘label’), including indication(s), recommended dose(s), route and method(s) of administration, contraindications, special warnings and precautions for use on which the licence is based and confirmation

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