General information about Compassionate use, named patient
In order to use medicines without Market Authorisation (MA) in Norway (or medicines that are not marketed in Norway), prescribers have to apply for compassionate use, named patient (in Norwegian: Godkjenningsfritak).
The Norwegian Medicines Agency (NOMA) evaluates applications for named patient use (the Norwegian Medicinal Products Regulation, sections 2-5, 2-6 and 2-7).
- The initiative and application for "compassionate use named patient" must come from a doctor, a dentist, a veterinarian or a fish health biologist.
- The prescriber must give a medicinal explanation as to why the patient cannot use a product with MA in Norway.
- The products are distributed via regular distribution channels (wholesalers and pharmacies).
- Companies are not permitted to promote the use of medicines without MA in Norway.
Compassionate use, named patient in hospitals
New and costly methods provide opportunities for achieving health gains, while also presenting challenges relating to prioritisation and resource allocation. To deal with this, a national system for the assessment of new and costly methods in specialist healthcare has now been introduced.
As a result, new drugs without MA must not be used in public hospitals until the hospital management has approved such use. This is the case even if the pharmaceutical company offers the medicine for free.