The Icelandic Medicines Agency has the authority to grant permission to offer a medicine for compassionate use. Medicines used for compassionate use do not have marketing authorization in the European Economic Area.
Compassionate Use involves making a particular medicine available for compassionate use to a group of patients with a disease that causes long-term or serious disability, or a disease considered lifethreatening, and which cannot be treated satisfactorily with a medicine that has marketing authorization in the European Economic Area. An application for a centralized marketing authorization (Centralized procedure, CP) for the medicine must be pending, or clinical trials for it must have been authorized.
Who can apply
A marketing authorization holder or their agent can apply
Delivery
The authorisation is sent by e-mail to the applicant's e-mail address
Cost
The cost of the application is according to the price list of the Icelandic Medicines Agency
Service provider
Icelandic Medicines Agency