In the UK, all medicines go through strict checks to make sure that they’re safe and effective. When a medicine passes all the checks, it’s granted a product licence and can be used to treat specific medical conditions.
Licensed medicines
To sell a medicine in the UK, the manufacturer must apply for a product licence from the Medicines and Healthcare products Regulatory Agency (MHRA).
The MHRA will only agree a product licence if:
- tests have proved that the medicine successfully treats the condition it was developed for,
- the medicine doesn’t have too many side effects or risks, and
- the medicine is made to a high standard.
How are medicines tested?
The medicine manufacturer may initially test some medicines on animals. However, to be sure that a medicine is safe and effective in humans, they also have to test the medicine on people. This is called a clinical trial.
Information from clinical trials is given to the MHRA when the manufacturer applies for a product licence.
What are unlicensed medicines?
An unlicensed medicine is one that does not have a product licence. For example:
- If only a very small number of people would use a medicine, there may be little commercial interest in marketing that medicine in the UK.
- You may have agreed to receive an unlicensed medicine as part of a clinical trial.
- The medicine may be waiting for approval from the MHRA.
- Your doctor may prescribe your medicine in a form that’s not readily available, for example, to be made up as a special preparation by your local pharmacy.
Below are some examples that show when an unlicensed medicine may be used:
- Your GP may believe that a specific medicine would work well for your condition, even though it hasn’t been licensed for that condition.
- Your GP may prescribe a liquid medicine that’s only licensed in tablet form. Medicines like this are often prescribed for children if they find it difficult to take adult medicine.
Unlicensed medicines and your pharmacist
Unlicensed medicines are usually made specially. They can be difficult to get hold of, so your pharmacist may have to make special arrangements to:
- make your medicine, or
- get your medicine from a manufacturer.
Sometimes your medicine may be made up as a special preparation by your pharmacist from raw ingredients, individually for you. This method of special preparation is called extemporaneous dispensing.
In other cases, your pharmacist may arrange to get the unlicensed medicine from a manufacturer who makes it specially, under a ‘Specials’ manufacturing licence.
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