Unlicensed Medicines

No medicine can be placed on the market without a Marketing Authorisation (formerly known as a Product Licence) granted by the Medicines and Healthcare Products Regulatory Authority (MHRA). This Marketing Authorisation signifies that the medicine concerned meets the appropriate quality standards and is safe and efficacious for its designated use. However, fully licensed products will not always meet the clinical needs of an individual patient in every situation. Therefore, the legislation provides an exemption to allow the manufacture, supply and administration of unlicensed medicines (i.e. medicines without a Marketing Authorisation) when necessary. In addition, provision is also made for licensed medicines (i.e. medicines with full Marketing Authorisation) to be prescribed for unlicensed indications, in unlicensed dosages or in unlicensed formulations i.e. "off-label".

The following issues must be considered before prescribing an unlicensed / off-label medicine:

• Only prescribe if the use is clearly justified from clinical / pharmaceutical perspective, and where no medicine with a Marketing Authorisation can provide optimal treatment
• Decision to initiate should be made by the clinician responsible for the patient's care (i.e. consultant) - they will be responsible for the welfare and any adverse reactions and may need to justify decisions taken.
• Appropriate documentation must be completed prior to prescribing (see policy links below), with advice and support from pharmacists.
• Ensure informed patient consent and suitable information provided to the patient prior to prescribing.
• Ensure arrangements for supply continuity if continued after discharge (see policy links below), and ensure comprehensive information on the rationale for use is provided to those prescribing beyond the initiation.

The full policies can be found by searching on AthenA / Code of Practice for Medicines Governance / Unlicensed Medicines (link only active if accessing via NHS network):

• Unlicensed Medicines Policy – see here
• “Off-label” Use of Medicines Policy – see here