Unlicensed medicines

In the UK most medicines are “licensed” but some are not. Here we explain why medicines are licensed and why some medicines do not have licenses. You will have been given this information by your doctor or pharmacist because the medicine prescribed for you is not licensed or is being used for a reason not covered by the license. We want to reassure you that we have thought very carefully about the best medicine for you and answer any questions you may have.

Why are medicines licensed?

The makers of medicines must ask the government for a “Marketing Authorisation” or “Product License” if they want to sell their medicines in the UK. They show evidence, from clinical trials, to the government’s Medicines and Healthcare products Regulatory Agency (MHRA) that their medicine:

• works for the illness to be treated
• does not have too many side effects or risks
• has been made to a high standard

How do the makers test medicines?

To be sure that a medicine works and is safe, the maker has to first try it on a small number of people in what is called a clinical trial. A clinical trial may be used to test how much of the medicine to give to a patient, if it works, or how safe it is. All clinical trials are carefully regulated in the UK. Information from clinical trial is given to the MHRA when the maker asks for a “Product License”.

When and why is an unlicensed medicine used?

If a medicine is used in a way that is different from that described in its licence, this is called “unlicensed” or “off-licence” use. This includes giving a medicine in a way that is different from that described in the licence.

There are several reasons why some medicines are used for illnesses or conditions not covered by their original license. Here are some examples of unlicensed uses:

• Use of a licensed medicine for an age group that is not covered by its licence
• Use of a licensed medicine for an illness that is not included in its licence
• The medicine is not available in the UK and we have 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”

Many medicines that are widely used are unlicensed. This gives doctors more choice about which medicine to use than if they could only use licensed medicines.

How do I know that these medicines are safe and will work?

This medicine may have been recommended by another doctor who is an expert, or your own doctor may have used it many times previously, or have read information and research that says it is the best one for you. The pharmacy department will ensure that the medicine has been manufactured to a good standard and is of an acceptable quality.

How will I know that my medicine is not licensed?

Your doctor should tell you. Unlicensed medicines may be made specifically or may be more difficult to obtain. Your pharmacist may tell you this and make special arrangements for you to get your medicine.

Should I be worried about taking these medicines?

If you are still worried after reading this information, please talk to your doctors or pharmacist. They are looking after you and have thought carefully about the best medicine for you and your condition.

What if I don’t want to take unlicensed medicines?

Talk it over with your doctor and tell them what you are worried about. They can tell you more about the information or advice they have about the specific medicine. They can also tell you about other treatments available and why they think this is the best one.

Can I get more information about my unlicensed medicine?

Your pharmacist may have an information leaflet about your medicine or illness. Please ask. Often there are support groups for people with a particular illness or condition. Ask your doctor, nurse or pharmacist for information.

If I am confused what should I do?

Talk to the person who gave you this information (usually your doctor or pharmacist). Ask them to explain and let them know what your concerns are.

How to obtain a further supply of an unlicensed medicine

If you need to continue with your medicine after leaving the hospital, the hospital doctor may ask your GP to prescribe it for you. Your GP will then give you a prescription, which you will need to take to your community pharmacist in order to get your medicine. If your GP is unable to do this for any reason, or if the pharmacist is unable to get hold of the unlicensed medicine, the hospital will continue to supply it for you.

Ref: 23-18-103
Review: 07/20