​​This phase takes place after the Regional Health Authority Forum makes a decision that a Single Technology Assessment should be carried out at the national level. The Norwegian Medicines Agency will then require the manufacturer/suppliers to submit documentation in accordance with the descriptions set forth in the template.

Economic analyses undertaken in the STAs shall be based on the recommendations by the Directorate of Health and NOMA guidelines.

NOMA requires that manufacturers/MAHs present documentation systematically as proposed in the template. The manufacturer/applicant must provide justification for any deviation from the template. Documentation can be presented in English or any of the Scandinavian languages. Documentation shall be submitted electronically. In cases where a health economic model is used to estimate cost-effectiveness, then that too shall be submitted.

Confidential material such as trade secrets or data pending publication that should not be made ​​public will be treated in accordance with current legislation (The Public Administration act and the Medicinal Products Act). NOMA then publishes the completed reports on their website.

The template was prepared by NOMA in collaboration with the Knowledge Centre and the National Working Group for the Introduction of New Methods in the Specialist Health service.

Publisert: 27.06.2016