The Norwegian Medicines Agency will approve or reject the application within 180 days. If the Norwegian Medicines Agency requests for supplementary information, the time limit is increased beyond the 180 days.

The application must be designed in accordance to the submission template. An important part in the template is pharmaco-economic analyzes - these must be based on the guidelines for submission of documentation. Applications should be sent to blaresept@legemiddelverket.no.

The guidelines and the submission templates are updated 15.10.2018. See logs for the changes to guidelines and changes to template

Guidance

NOMA offers guidance to identify and discuss any uncertainties relating to the reimbursement process and the preparation of the reimbursement application. 

Very small patient groups

This memorandum describes the arrangements for single technology assessments of pharmaceuticals for very small patient groups with extremely severe conditions.

Maximum prices and reimbursement prices

Price and reimbursement list updated 2018-12-03 (Excel)

The list contains price and reimbursement information on all prescription-only medicines for humans with a maximum price in Norway. The maximum PPP (exclusive VAT) and the maximum PRP (inclusive VAT) are given. Please note that these are maximum prices and the actual prices may therefore be lower than stated. More information on maxium price.

Oppdatert: 31.10.2018

Publisert: 27.06.2016

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