Legality

Unlicensed medicines may be prescribed if the prescriber is satisfied that there is no licensed alternative that would meet the patient's needs and that there is sufficient evidence base and/or experience to show that the medicine is safe and effective.

The prescriber takes responsibility for prescribing the unlicensed medicines and is responsible for monitoring the efficacy and safety of the treatment.

Unlicensed medicines, and the justification for their usage, must be documented in the clinical notes

Concerns about the provenance and testing of an unlicensed medicine?

Contact the MHRA (mhra.gov.uk), the government agency responsible for the safety of medicines.

See also the GMC guidance Good Practice in Prescribing and Managing Medicines (2013).