Unlicensed and off-label uses of medicines: definitions and clarification of terminology

Br J Clin Pharmacol

5 August 2017 - The terms “licensed”, “unlicensed”, and “off-label”, often used in relation to marketing and prescribing medicinal products, may confuse UK prescribers.

To markset a medicinal product in the UK requires a Marketing Authorisation (“product licence”) for specified indications under specified conditions, regulated by the Medicines and Healthcare products Regulatory Agency (MHRA). The Marketing Authorisation includes the product's agreed terms of use (the “label”), described in the Summary of Product Characteristics (SmPC). Prescribing a licensed product outside those terms is called “off-label” prescribing. Products for which no-one holds a UK Marketing Authorisation are unlicensed.

Prescribers can prescribe authorised products according to the conditions described in the SmPC (“on-label”) or outside those conditions (“off-label”). They can also prescribe unauthorised products, unlicensed in the UK, if they are licensed elsewhere or if they have been manufactured in the UK by a licensed manufacturer as a “special”.

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Michael Wonder

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Michael Wonder