Managing medicines: Licensed and unlicensed medicines

Last updated: Sunday, July 11, 2021

A ‘licensed medicine’ is a medicine that has a marketing authorisation from the UK Medicines & Healthcare products Regulatory Agency (MHRA) or European Medicines Agency (EMA), enabling it to be prescribed in the UK. The marketing authorisation is an indication that the medicine has been appropriately tested in clinical trials to evaluate its efficacy and safety, and that the dose and method of administration are appropriate, and so on. Most medicines with a marketing authorisation can be found on the emc website, in the BNF, or on a dedicated section of the MHRA website.

An ‘unlicensed medicine’ is one without a marketing authorisation for the UK. It could, for example, be a medicine that is licensed as a medicine abroad (e.g. ajmaline), or it could be a nutritional supplement (e.g. some vitamin preparations).

A so-called ‘special’ is a formulation that is manufactured to meet the special clinical needs of an individual patient when a licensed product isn’t suitable. It might, for example, be an unusual strength, an oral liquid instead of a tablet, or be free from a particular additive. The Royal Pharmaceutical Society provides detailed guidance on supplying ‘specials’.

When a medicine is licensed to treat one condition but is prescribed to treat something else instead, this is said to be ‘off-label’ or ‘off-licence’ prescribing; some people would call this an ‘unlicensed indication’.

There may be less evidence to support the safety and efficacy of an unlicensed medicine or a medicine prescribed off-licence. This doesn’t mean that it shouldn’t be used, but it means that patients ought to know about it, and that prescribers and pharmacists should monitor such patients carefully. NICE has produced Evidence Summaries for some unlicensed and off-label medicines to help NHS planning and decision-making.

Many medicines taken by children are 'off-label' or unlicensed. There is a helpful description of what this means for children and parents on the Medicines For Children website.

  • Find out where your dispensary keeps unlicensed medicines. 

  • Is there an SOP for supplying unlicensed medicines in your Trust? 

  • Talk to your paediatric or ITU pharmacist about unlicensed medicines. Why do you think that many medicines used in these situations are not licensed?

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