Off-Label Use of Medicines: Legal Aspects

  • June M. Raine
Part of the Medical Radiology book series (MEDRAD)


The use of medicines, including contrast media, outside the terms of a marketing authorization is acceptable within European legislation, subject to provisos. This takes account of the limited access to appropriately authorized medicines for certain patient populations and therapeutic areas, in particular medicines for use in children. The physician who prescribes an unlicensed or off-label medicine should be satisfied that such use reflects a favorable benefit–risk balance according to the scientific evidence, current clinical opinion and guidance. Prescribers should provide patients with appropriate information and explanation, and should report any suspected adverse reactions associated with unlicensed and off-label use to the national authority responsible for drug safety monitoring.


Marketing Authorization European Legislation Patient Information Leaflet Suspected Adverse Drug Reaction Authorization Holder 
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Copyright information

© Springer-Verlag Berlin Heidelberg 2014

Authors and Affiliations

  1. 1.Medicines and Healthcare Products Regulatory AgencyLondonUK

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