Unlicensed Medicines

Unlicensed Medicines


The U symbol is used through out the formulary to indicate an unlicensed preparation or dose.

The term ‘unlicensed medicine' is normally applied to those medicines which do not have a UK Marketing Authorization (MA).

Such products are not subject to the strict licensing controls of the MHRA/EMA and neither the prescriber nor pharmacist can make the same assumptions of safety, quality and efficacy that they would with licensed items.

Unlicensed products are ordered specially and are not stocked; therefore a delay in obtaining stocks may be incurred. These ‘specials’ may be supplied when clinical need for the individual patient demands, given no commercial alternative is available. Specials are often very costly

The use of unlicensed medicines is the responsibility of the prescriber.

Prescribing and supply of unlicensed medicines (or medicines to be used outside their licensed indications) presents a risk to individual patients, prescribers, nurses and pharmacists.

Prescribers are therefore reminded of the following:

  • Unlicensed products are not intended for routine, ongoing use.
  • Where suitable licensed alternatives to unlicensed products exist these should always be used in preference to unlicensed medicines
  • Wherever an unlicensed medicine is prescribed, the prescriber is professionally accountable for his judgement in so doing and may be called upon to justify his actions.
  • A pharmacist who manufactures, prepares or procures an unlicensed medicine in response to a prescription is professionally accountable for any harm caused by a defect in the medicine which is attributable to his own actions or omissions.
  • A General Practitioner is not obliged to prescribe an unlicensed medicine.
  • Prescribers working within MKUHFT should follow the guidance and complete the appropriate forms in the unlicensed medicines policy



Quality Assessment of Unlicensed Medicines (November 2016)

The purpose of this document is to provide detailed guidance on the pharmaceutical quality assessment of unlicensed medicines. The principles are applicable both to unlicensed medicines sourced from other legal entities and unlicensed medicines prepared in house.

It has been produced on behalf of the NHS Pharmaceutical Quality Assurance Committee, the NHS Pharmaceutical Production Committee and the NHS Pharmaceutical Aseptic Services Group by the NHS Unlicensed Medicines Working Group.

Last updated by: Dupe Fagbenro on 15-10-2018 16:04