Norway has set out how its national HTA process will work for medicines covered by EU joint clinical assessments. The update adapts Norwegian submission routines to the EU HTA Regulation, while keeping health-economic assessment, national PICO clarification and adoption decisions within the Norwegian process.
The Norwegian Medical Products Agency (Direktoratet for medisinske produkter, DMP) published Økt bruk av felleseuropeiske metodevurderinger (Increased use of joint European health technology assessments) on 22 May. The agency said more assessments are now being carried out through European cooperation, and that DMP and New Methods (Nye metoder) have developed routines for suppliers whose medicines fall under the Regulation.
DMP said 15 joint European assessments, known as joint clinical assessments, are already in progress and that more will start during 2026. These assessments cover relative efficacy and safety. Health-economic assessment and decisions on introduction will continue to be made by each country.
Suppliers must therefore still request a national HTA for medicines assessed under the EU process. DMP has updated its documentation templates so that they also apply to medicines covered by the HTA Regulation, and to make clearer which parts of the evidence package are covered by the European joint clinical assessment.
The agency is also offering early national dialogue to clarify Norwegian PICO requirements and to guide companies on additional documentation needed for national HTA. The first Norwegian requests for medicines covered by the Regulation will act as pilots, and DMP says the process will be adjusted as experience develops.
Companies may submit national HTA documentation before the public joint clinical assessment report is available. DMP will not start formal case processing until the report has been published. The update gives companies a clearer route for aligning European clinical evidence with the national economic and decision-making steps that remain decisive for access in Norway.
Source: Norwegian Medical Products Agency
Link: Økt bruk av felleseuropeiske metodevurderinger (Increased use of joint European health technology assessments)
Date: 22 May 2026
