What does a medicine licence mean?
When a new medicine is developed, it is tested through clinical trials to check how well it works and whether it is safe. If the results are positive, the manufacturer applies for a licence. In the UK this is issued by the Medicines and Healthcare Products Regulatory Agency (MHRA) or, in Europe, by the European Medicines Agency (EMA).
A licence sets out:
- who the medicine is for
- how it should be stored and taken
- known side effects and safety warnings
- the condition or conditions it is approved to treat
This information is published in the patient information leaflet supplied with the medicine.
What is off-label prescribing?
Sometimes a licensed medicine may be prescribed for a condition that is not included in its licence. This is called off-label prescribing.
A prescriber may recommend a medicine in this way if, in their professional judgement, the likely benefit outweighs the potential risk. Your medical history, allergies, and current treatments are always taken into account.
It is important to understand that off-label prescribing does not mean a medicine is unlicensed. The drug has still passed the normal licensing process, but it is being used for a different purpose than the one originally approved.
What does this mean for you?
- The patient information leaflet will usually only describe the licensed use. For example, semaglutide (Ozempic) is licensed for type 2 diabetes, so the leaflet does not mention its use in weight management.
- Evidence for the off-label use may be more limited, though prescribers rely on clinical studies and accepted medical practice when making a decision.
- You will always be told if your medicine is prescribed off-label, and you will have the chance to ask questions before treatment begins.
Our commitment
At Chelsea Slimming Clinic your safety is our priority. We will explain clearly whenever a medicine is prescribed off-label and provide information about possible risks and side effects. If you are unsure or would like further advice, please speak to your prescriber or contact us directly.