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Submission of documentation for single technology assessment of medicines

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  • : 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 developers (HTD) submits the documentation for STAs to the Norwegian Medical Products Agency (NOMA).

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    The submission template and guidelines were updated in November 2023. 

    The main purpose of the update was to ensure that NOMA receives a more complete documentation from the HTDs when the HTA process begins. This will contribute to faster assessments with fewer interruptions. The guidelines have been updated to better align with current practice, including the new EU Regulation on HTA (HTAR).

    In addition, the submission template is harmonized with NOMA’s report template. 

    Guidelines and submission template 

    Go to the pages with the following documents: 

    We also have the following documents, which you can find on the submission template webpage: 

    • Submission checklist 
    • Excel sheet for budget calculations – in accordance with the guidelines 
    • 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 (e.g., JPEG). 

    The guidelines and submission template is only available in English. However, it is possible to 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 us minimum three months in advance of the planned submission date (week number) of documentation for STA. 

    See information about notification and the submission process. 

    HTA of vaccines

    We have information about documentation for HTA of vaccines in Norwegian only. 

    See information here (in Norwegian).

    Confidentiality guidelines

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

    Confidentiality guidelines for HTAs (PDF, in Norwegian)