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: http://www.braincouncil.eu/golup/