Unlicensed medication, also referred to as off-label or off-license, is medication that is prescribed for a use other than that listed in the terms of its license, within the country of use.
The license says what conditions the medication can be used for, what age people it can be given to, how much can be given and how to give it. However, there are many medications that are used either outside of the terms of their licenses or without a license at all, when it is in the person’s best interests.
Sometimes, doctors use medicines for a health problem even if those medicines don’t have an official license for treating that specific problem. This is because doctors know from experience or research that the medicine can help, even though it’s not officially approved for that use. It’s like finding a new way to use something that was made for a different purpose. The medicine is safe and works well for its original purpose, and doctors have learned that it can also help with other health issues. This is done when the doctor thinks that this medicine is the best option for the person's health.
The UK doctors’ regulatory body, the GMC, has clear guidelines for GP’s to follow:
Prescribing medicines outside their UK license – GMC Prescribing Guidelines – trans healthcare
"In our prescribing guidance we are clear that it may be necessary for doctors to prescribe medicines outside the terms of their license. Doctors may do this where, on basis of an assessment of the individual patient, they conclude, for medical reasons, that it’s necessary to do so to meet the patient’s specific needs."
"As set out by NHS England in their service specification for Gender Identity Services for adults, most recommendations made by a specialist for GPs to prescribe will be for medicines to be used outside the indications approved by the Medicines and Healthcare products Regulatory Agency."
" If you’re a GP, collaborate with a gender specialist service to provide effective and timely care for your transgender and gender diverse patients. This may include:
https://www.gendergp.com/is-unlicensed-medication-safe/
https://www.gmc-uk.org/professional-standards/ethical-hub/trans-healthcare#Prescribing