Compassionate use program
The EU regulatory framework makes it possible for non-authorized medicines to be made available under certain circumstances. This is achieved through a compassionate use program.
According to article 83 of Regulation (EC) No 726/2004, medicinal products without a Marketing Authorisation ‘may be made available for compassionate reasons to a group of patients with a chronically or seriously debilitating disease or whose disease is considered to be life-threatening, and who can not be treated satisfactorily by an authorized medicinal product.’
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