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Submission of documentation for single technology assessments

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Changes

  • : Updated guideline and templates.
  • : Added information about notification three months before submission, HTA of vaccines and confidentiality guidelines

New medicines are subject to a single technology assessment (STA) in Norway. The health technology developer (HTD) submits their documentation for an STA to the Norwegian Medical Products Agency (NOMA).

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    NOMA has updated the guideline for the submission of documentation for single technology assessments and the submission template as of July 2026. 

    We now clarify our requirements for “must” and “should” criteria to ensure that we receive all the documentation we need at the start of an STA from HTDs. This will help us assess new medicines faster and with fewer interruptions. 

    The submission template is updated according to the guideline.

    Guideline and submission template 

    Access these pages to find the following documents: 

    In addition, you can find the following documents on the submission template webpage

    • Submission checklist 
    • Excel sheet for budget calculations in accordance with the guideline
    • Tool for calculating age-adjusted utility weights and severity 

    We aim to meet universal design requirements. Therefore, we ask that all submitted tables be formatted as tables, not pasted images like JPEG. 

    The guideline and submission template is only available in English. You can submit the documentation in English, Norwegian, Danish, or Swedish. 

    Notify three months before submission

    It is important for NOMA to conduct efficient assessments and plan its resources. When NOMA receives a submission notice, we begin recruiting medical experts for the HTA so that recruitment can be completed by the time the assessment starts. Therefore, HTDs must notify NOMA minimum three months in advance of the planned submission date (week number) of documentation for STA. 

    Find information about notifications and the submission process

    Health technology assessments of vaccines

    We have information about documentation for vaccine technology assessments (only available in Norwegian). 

    Find information about vaccine HTAs (website in Norwegian)

    Confidentiality guideline

    NOMA has guidelines on what information is generally considered confidential under existing legislation.

    Confidentiality guideline for HTAs (PDF in Norwegian)