Compassionate use

Unautorised medicinal products for compassionate use can be made available to Norwegian patients.

To a group of patients

A new Guideline will be published at the end of Q2. In the meantime, please read more about this at the EMA website. 

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