Sideinnhold
The templates is based on Guidelines for the submission of documentation for single technology assessment (STA) of pharmaceuticals and will be kept updated in accordance with the valid version of the guidelines. The template was last updated in October 2021.
Please note that chapter 4 only should include a short description of relevant clinical studies; an thorough discussion and contextualisation for data regarding relative effectiveness, model parameters and relevance for Norwegian clinical practice should be included in chapter 9.
For pharmaceuticals following track a and d submissions, please contact NOMA for further guidance.
Download the template in Word format - use for track a
Download the template in Word format - use for track b,c and d
Submission
Pharmaceutical companies prepare documentation at the request of the Norwegian Medicines Agency. The documentation is submitted by e-mail to: post@noma.no, with a copy to either blaresept@noma.no (pharmaceuticals to be funded by the National Insurance Scheme) or sykehus@noma.no (pharmaceuticals to be funded by the Regional Health Authorities). It is important to include the following information in the e-mail text: Brand name, active substance, and Nordic package number covered by the documentation.
Please submit the documentation using the following format:
- Dossier in Word format.
- File name for pharmaceuticals to be funded by the National Insurance Scheme:
«01 ».docx - File name for pharmaceuticals to be funded by the Regional Health Authorities:
«01 ».docx
- Attachments as PDF or Word files.
- File names with continuous numbering, e.g.
«02 »
- Reference list as packed EndNote-library (.enlx) or .txt-file.
- PDF of full text papers should be included in packed library or as separate attachments.
- Cost-utility analysis as Excel file.
- Budget impact model as Excel file.
File name cannot exceed 42 characters due to technical requirements. Use abbreviations if necessary.
