Compassionate use
Unautorised medicinal products for compassionate use can be made available to Norwegian patients.
In a group of patients
Compassionate use of unauthorised medicinal products in a group of patients must be submitted to the Norwegian Medicines Agency in line with the requirements for a regular application for a clinical trial. It will be advantageous to our assessors that a statement is included in the covering letter informing that the application concerns compassionate use.
The following criteria have to be fulfilled to claim compassionate use:
- The illness has to be chronic, seriously debilitating and/or life threatening.
- The illness can not be treated satisfactorily by an authorised medicinal product.
The Norwegian Medicines Agency does not accept that the duration of the study is “until the product has been marketed”. If there is no scientific foundation for the duration of the study we ask that the duration is set to 1 year. This can be extended further by submitting an application to the Norwegian Medicines Agency.
Compassionate use on a named patient basis
Medical doctors and dentists have the possibility to prescribe medicinal products without a Norwegian marketing authorisation or that have not been marketed in Norway at their own responsibility. An application has to be approved by the Norwegian Medicines Agency before dispatch unless the medicinal product has a marketing authorisation in:
- the EEA
- the USA
- a member country of PIC/S (Pharmaceutical Inspection Cooperation Scheme)
- a country that has signed an agreement of mutual recognition with the Norwegian Medicines Agency
Pharmacies are instructed to inform the Norwegian Medicines Agency after dispatch of a medicinal product that is pre-approved according to the above mentioned categories. The same application form must be used whether the medicinal product is pre-approved or not.
Unauthorised medicinal products can be prescribed through this program. Applications must be approved by the Norwegian Medicines Agency before dispatch. The medicinal product must have undergone clinical trial(s) in Norway for an application to be approved.
Sist gjennomgått: 19.06.2007
Første gang publisert: 19.06.2007