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Review
. 2017 Dec;83(12):2615-2625.
doi: 10.1111/bcp.13394. Epub 2017 Sep 26.

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

Jeffrey K Aronson  1 , Robin E Ferner  2   3
Affiliations
Review

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

Jeffrey K Aronson et al. Br J Clin Pharmacol. 2017 Dec.

Abstract

The terms 'licensed', 'unlicensed', and 'off-label', often used in relation to marketing and prescribing medicinal products, may confuse UK prescribers. To market a medicinal product in the UK requires a Marketing Authorization ('product licence') for specified indications under specified conditions, regulated by the Medicines and Healthcare products Regulatory Agency (MHRA). The Marketing Authorization 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 Authorization are unlicensed. Prescribers can prescribe authorized products according to the conditions described in the SmPC ('on-label') or outside those conditions ('off-label'). They can also prescribe unauthorized products, even if they are 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'. The complexities of this system can be understood by considering the status of the manufacturer of the product, the company that markets it (which may or may not be the same), the product itself, and its modes of use, and by emphasizing the word 'authorized'. If a Marketing Authorization is granted to the supplier of a product, it will specify the authorized modes of use; the product will be prescribable as authorized (i.e. 'on-label') or in other modes of use, which will all be off-label. Unlicensed products with no authorized modes of use can be regarded as 'unauthorized products'. All 'specials' can be regarded as authorized products lacking authorized modes of use.

Keywords: authorized medicines; licensed medicines; market authorization; off-label prescribing; unlicensed prescribing.

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Figures

Figure 1
Figure 1
Four factors that influence the benefit to harm balance of drug therapy: features of the patient, features of the illness, the evidence of benefit, and adverse effects or reactions
Figure 2
Figure 2
How authorized and unauthorized products are used and prescribed; the categories (a)–(d) correspond to those in Appendix 4; *the MAH and the licensed manufacturer may or may not be the same company and may or may not be the company that develops the drug; PoM = prescription‐only medicine
See this image and copyright information in PMC

References

    1. Advanced therapy medicinal products: regulation and licensing. Available at https://www.gov.uk/guidance/advanced‐therapy‐medicinal‐products‐regulati... (last accessed 8 May 2016).
    1. Penn RG. The state control of medicines: the first 3000 years. Br J Clin Pharmacol 1979; 8: 293–305. - PMC - PubMed
    1. The Human Medicines Regulations . 2012. Available at http://www.legislation.gov.uk/uksi/2012/1916/pdfs/uksi_20121916_en.pdf (last accessed 8 May 2016).
    1. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67). Available at http://ec.europa.eu/health/files/eudralex/vol‐1/dir_2001_83_consol_2012/... (last accessed 8 May 2016).
    1. World Health Organization . Marketing authorization of pharmaceutical products with special reference to multisource (generic) products: a manual for drug regulatory authorities – regulatory support series no. 005. Available at http://apps.who.int/medicinedocs/en/d/Js2273e/10.html (last accessed 8 May 2016).

MeSH terms

Substances