Access to treatment
The MHRA ensures any new medicine is safe and effective, and that the benefits outweigh possible side effects. The licence confirms what condition a medicine should be used for and the recommended dose.
The MHRA looks at:
the safety and quality standards of medicines, medical equipment and blood products
the safety of the supply chain for medicines, medical equipment and blood products
educating the public and healthcare professionals about the risks and benefits of medicines, medical equipment and blood products
supporting research and development that benefit public health
working with UK and international regulations so that they protect public health and support access to safe medicines and medical devices
At the end of their review, the MHRA will decide whether to approve the medicine. Once a medicine has marketing authorisation, it is 'licensed' or 'approved'. All these terms mean the same thing.
Go to more information about the MHRA on the GOV.UK website
The MHRA works with other medicines regulators in certain countries around the world.
If a medicine has been approved by another regulator, the MHRA can consider their review and how they made their decision. This makes the MHRA process faster. They may then approve a medicine. Or they can reject an application if they don’t think there is enough evidence.
It can take many years for new medicines to go through the research, clinical trials and licensing process. Sometimes, doctors can access new medicines that haven’t been licensed yet through the Early Access to Medicines Scheme (EAMS).
The EAMS aims to give people with life threatening or severely debilitating conditions early access to medicines. Doctors can use the scheme when no suitable treatment is available. Or current treatments do not work well enough.
After getting a licence, other organisations also review the medicines.
These organisations decide which medicines work well and are cost effective to use. They are:
The National Institute for Health and Care Excellence (NICE) in England
The Scottish Medicines Consortium (SMC) in Scotland
The All Wales Medicines Strategy Group (AWMSG) in Wales
After licensing, the MHRA continues to collect information. This information is about how well the medicine works and about the side effects. They continue to check the safety and effectiveness of the medicine.
A medicine is usually licensed for a specific:
type of illness or cancer
age group
dose (how much medicine to take)
Sometimes a doctor might want to use a drug in a way that is not included in the drug's licence. This happens when they think it might help a patient for a specific reason.
In this case, they can prescribe that medicine for the patient. If they do this, the doctor is responsible for making sure the medicine is right for the patient. And that the benefits outweigh the risks. This is called 'off label prescribing'.
Last reviewed: 30 Oct 2026
Next review due: 30 Oct 2029
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Once a medicine has a licence, organisations will decide if it should be available as part of free healthcare.
Sometimes there are treatments which aren’t available on the NHS. There are other ways you might be able to access a treatment that isn’t available on the NHS.
Treatments can include surgery, radiotherapy and drug treatments (such as chemotherapy, hormone therapy or targeted cancer drugs). Find out about treatments and how to cope with side effects.
There are several decisions to be made about a cancer treatment before you can have it on the NHS or HSC.
