Unlicensed medicines

You might have been prescribed a medicine that is ‘unlicensed’.

An unlicensed medicine is not officially approved ('licensed') for treating your health condition at present. Reasons for this include:

  • the number of people with the same condition is too small for a clinical trial to take place
  • the medicine is having checks to be licensed, but the process is taking a long time

If your doctor prescribes an unlicensed medicine, they feel that it is a safe and effective treatment for you. There might be more reasons why they have prescribed it.

It's important that you always take the medicine how your doctor tells you and as it says on the medicines label.

Your doctor considers the medical evidence available when prescribing an unlicensed medicine.

Licensed medicines

In the UK, all medicines have checks (such as clinical trials) to make sure that they are safe and effective.

The Medicines and Healthcare products Regulatory Agency gives licences for medicines when they pass all the checks. This is also called marketing authorisation. It means that the medicine is now officially approved to treat a health condition or range of conditions.

The licence is only for the particular health condition or range of conditions that the checks covered.

Why you've been prescribed an unlicensed medicine

Your doctor might prescribe an unlicensed medicine for you if:

  • they believe that this medicine would work well for your condition, even though it is licensed for a different one 
  • the medicine is not available in the UK and we have to get it from another country that has similar high standards of licensing to 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. As we have to prepare this as a special medicine, it is unlicensed
  • they have chosen to use a product that is safe, but might not be classified as a medicine. This would not have been through the medicine licensing process

Your doctor considers the medical evidence when prescribing an unlicensed medicine. 

Children’s unlicensed medicines

A lot of medicines are only tested with adult volunteers. This means that they are not licensed for treating children.

Our hospitals have processes to review medicines and decide which are best to treat children and young people. Your doctor or pharmacist can tell you if the medicine prescribed for your child is one commonly used for children.

Getting your 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 gives you a prescription, which you take to your local pharmacy to get the medicine. If your GP cannot do this for any reason, or if the pharmacist cannot order the unlicensed medicine, the hospital will continue to get it for you.

It is important that you always take the medicine as explained on the label.

If you have any side effects or concerns, you can talk about them with the doctor looking after you.

Information leaflet that comes with your medicine

Any 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 that you take is unlicensed for your health condition, the information leaflet might not include details on how the medicine might affect you.

If your condition is not covered in the leaflet

If the leaflet that comes with your medicine does not have information on your condition, please ask your doctor or pharmacist.

We have information about a range of conditions and medicines. Please ask us for information on your condition or medicine.

If the information is not in English

If the medicine comes from another country and the packaging is not in English, we might have the same information in English. Please ask us if you do not have the information in English.

Concerns about unlicensed medicines

If you have any concerns about taking your medicine, please speak to your doctor or pharmacist. They can help you to make the right choice and it is important that they understand your concerns.

There may be other treatment options. Your doctor or pharmacist can talk to you about these options if you decide not to take an unlicensed medicine.

Support groups

There are many support groups, where information is shared and people use their own experiences to help each other. You might be able to join a support group for your condition.

Please tell your doctor or pharmacist if you would like more information about support groups. They can direct you to the right place.

Resource number: 2225/VER6
Last review: April 2021
Next review: April 2024

Trusted Information Creator. Patient Information Forum

Do you have any comments or concerns about your care?

Contact our Patient Advice and Liaison Service (PALS)

Is this health information page useful?