Unlicensed Medicines and Named-Patient Supply Explained
Not every patient need can be met by a licensed medicine. Sometimes a prescriber needs a different strength, a liquid version of a tablet, or a product that is not licensed in their own country. That is where unlicensed medicines, often called specials, come in.
What counts as an unlicensed medicine
In the UK, an unlicensed medicine can be supplied to meet the special clinical needs of an individual patient, on the responsibility of a prescriber. The legal basis sits in the Human Medicines Regulations 2012. Unlicensed products may be made to order in the UK or imported from another country where they are licensed.
The prescriber's responsibility
Because the product has not been assessed for that specific use, the prescriber takes on greater responsibility for the decision. Good practice is to use a licensed product where one is suitable, and to record why an unlicensed option was chosen.
How supply works
The prescriber identifies a clinical need that a licensed product cannot meet.
A pharmacy or clinic places an order with a licensed supplier, referencing the individual patient.
The supplier sources the product and provides documentation such as a certificate of analysis or conformity.
Records are kept so that supply can be traced and audited.
Named-patient supply across borders
Many countries have their own named-patient or compassionate-use routes. Private clinics abroad sometimes need medicines that are easier to obtain from the UK. Acorn Pharmaceuticals is developing a compliant route to help clinics serve these patients, and we are always happy to discuss what is possible.
Talk to Acorn Pharmaceuticals: email gb@acornpharmaceuticals.co.uk or message us on WhatsApp.
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