You may have been prescribed a medicine that is ‘unlicensed’. This page explains what this means, and how you can find more information about the medicine your doctor has given to you. If you have any questions or concerns, please speak to your doctor or pharmacist.
In the UK, all medicines go through checks (such as clinical trials) to make sure the medicine is safe and helpful for people taking it. The Medicines and Healthcare products Regulatory Agency (MHRA) grants licences for medicines when they pass all the checks.
The licence (also known as marketing authorisation) will only be for the health condition, or range of conditions, that the medicine was checked for.
An unlicensed medicine is medicine that is not licensed for treating your health condition at this time.
The medicine might be unlicensed because the number of people with the same condition is too small for a clinical trial to take place. It may also be unlicensed because the medicine is going through the checks to be licensed, but the process can take a long time.
Your doctor might have prescribed an unlicensed medicine for you. There are different reasons why this might happen.
- Your doctor thinks that this medicine would work well for your condition, even though it is licensed for a different condition.
- The medicine is not available in the UK, and your doctor has to get it from another country which has similar high standards of licensing as the UK.
- The medicine is normally available in one form, such as a tablet, and your doctor thinks that a liquid form is better for you. This will have to be made up as a special medicine, so it will be unlicensed.
- Your doctor has chosen to use a product that is safe but may not be classified as a medicine, and so it will not have been through the medicine licensing process.
Your doctor will consider the medical evidence when prescribing an unlicensed medicine.
Children’s unlicensed medicines
A lot of medicines are only tested with adult volunteers. This means they will not have a licence for use in children.
Our hospitals have processes in place to review medicines and decide on what is best to treat children and young people. Your doctor or pharmacist will be able to tell you if the medicine prescribed for your child is one commonly used for children.
Information about your medicine
All medicines can have side effects. In the UK, all licensed medicines must come with an information leaflet about how to take the medicine and any possible side effects.
If the medicine you are taking is unlicensed for your health condition, the information leaflet might not have details on how the medicine might affect you. If the leaflet that comes with your medicine does not have information on your condition, please ask your doctor or pharmacist for more information.
If the medicine comes from another country and the information is not in English, your doctor or pharmacist might have the same information. Please ask them if you do not have the information in English.
Your doctor or nurse will have leaflets on different conditions and medicines. Please ask them for a leaflet on your condition or medicine if you would like to read more information.
There are many support groups that give information to patients, and there might be one for your condition. Please tell your doctor or pharmacist if you would like more information and they can direct you to the right place.
For more information about unlicensed medicines, please talk to a member of staff caring for you. They can ask a medicines information team member to speak to you and answer your questions.
Concerns about unlicensed medicines
It is important that you always take the medicine how your doctor has told you, and as it says on the medicines label. If you have any side effects or concerns, you should talk to the doctor caring after you.
If you have any concerns about taking your medicine, please speak to your doctor or pharmacist. They will help you make the right choice, and it is important that they understand what your concerns are. There may be other treatment options, and they can talk to you about these if you decide not to take an unlicensed medicine.
Prescriptions for an unlicensed medicine
If you need to continue with your medicine after leaving the hospital, the hospital doctor might ask your GP to prescribe it for you. Your GP will give you a prescription, which you will need to take to your local pharmacy to get your medicine. If your GP cannot do this for any reason, or if the pharmacist cannot get hold of the unlicensed medicine, the hospital will continue to get it for you.
Ref number: 2225/VER6
Date published: April 2021 | Review date: April 2024
© 2021 Guy’s and St Thomas’ NHS Foundation Trust
A list of sources is available on request
If you have any questions or concerns about the medicines you have been given, please contact your doctor. You can also contact the Pharmacy medicines helpline
Phone: 020 7188 8748, Monday to Friday, 9am to 5pm.
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