Unlicensed medicines

Unlicensed Medicines

Some medicines are prescribed "unlicensed" or "off-label".

The terms "off-label" and "unlicensed" are interchangeable and carry the same meaning.

Medicine licences

Before a medicine is made available to the public, the manufacturer of the new drug rigorously tests it to determine its safety by conducting clinical trials.

Clinical trials test the drug's effectiveness at treating the condition for which it was designed. These trials can also identify any potential risks associated with taking the medicine, such as side effects.

If the trials are successful and the drug is shown to be effective in treating the condition for which it was designed, a licence can be granted by the Medicines and Healthcare Products Regulatory Agency (MHRA) or the European Medicines Agency (EMA).

The licence determines for which condition(s) the treatment can be used, who can and cannot take it, how it should be stored and administered, and even which companies are authorised to manufacture the drug.

You can find this information in the patient information leaflet supplied with your medicine.

Unlicensed use

Off-label or unlicensed use of a drug is when a medicine is prescribed to treat a condition for which it was not initially intended, but may be effective.

If a doctor believes that the treatment will effectively treat your condition, and that the benefits outweigh any potential risks, they will prescribe the medicine off-label.

The doctor will inform you if a drug is being prescribed to you off-label and will make you aware of any potential risks associated with off-label use.

When taking any unlicensed medication, it's important to always follow your doctor's advice.

You should never take a medicine off-label unless a doctor has deemed it suitable for you.

Staying safe with Prescription Doctor

When our doctor prescribes a medicine off-label, they will make it their prerogative to inform you that they are prescribing the medicine off-label and of any side effects or risks associated with prescribing the treatment off-label.

In some cases, the patient information leaflet may acknowledge off-label use cases for the medicine you are taking. You should familiarise yourself with the information detailed in the leaflet and remain vigilant of any side effects during your course of treatment.

Authored & Reviewed By

Mohamed Imran Lakhi

MPharm - Lead Pharmacist

Imran Lakhi is the superintendent pharmacist and founder at Prescription Doctor. He has been at the core of our team.

Published on: 30/01/2020 Reviewed on: 05/06/2025