Unlicensed and Off-Label Medicine - What’s the deal?

Medication Licences:

In the UK, the sale of medicines is managed by a licensing system run by the MHRA. Each medicine has a licence that includes information about its proven effectiveness in clinical trials. Once medicine has been proven to be clinically effective against a condition in a group of patients, it can be marketed as a treatment in that area. The medicine’s licence contains that information about its effectiveness and safety.

Off-Label Medication:

Sometimes, there might be evidence that a medicine is effective at treating conditions or patient groups that aren’t listed on its licence. In that case, the prescriber can prescribe the medicine for that “off-label” purpose. When they do this, they have to be sure that the medicine is safe and effective for that purpose, based on the clinical data, national guidance and their own experience.

Unlicensed Medication:

Sometimes, the licensed medicines on the market aren’t quite right for a patient or group of patients. In that case, a prescriber can request a medicine be prepared to meet, or better meet, the patient’s needs. Again, the prescriber will always make sure that the unlicensed medicine is supported by enough evidence to be safe and effective for the patient.