Our proposal

We believe that off-label use of medicinal products
should only occur if the following criteria are met:

Presence of a medical therapeutic need based on a current examination of the patient by a suitably qualified health care professional;

Absence of authorised treatment and licensed alternatives tolerated by the patient or repeated treatment failure;

A documented review and critical appraisal of available scientific evidence favours off-label use to respond to the unmet medical need of the individual patient

Patients (or their legal representative) must be given sufficient information about the medicines that are prescribed to allow them to make an informed decision;

Presence of established reporting routes for outcomes and adverse events linked to off-label use.


The Declaration will soon be available in other languages.