Good Off-Label Use Practice of Medicines

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Before a drug makes it onto the market it is vigorously tested and needs to be authorized, either by a national competent authority or EMA, the European Medicines Agency.

All the information on when a medicinal product can and cannot be used can be found on the label, also known as leaflet. However, products are also prescribed and used outside these terms; this is known as ‘off-label use’.

There is currently no EU-wide harmonised framework determining when to use medicines off-label.

A number of health organisations are calling for a Good Off-Label Use Practice, a blueprint for a clear, European-wide framework to ensure patients’ safety and help healthcare professionals make more informed decisions.

Find out more about the declaration here:

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