​​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 (for pharmaceuticals to be funded by the "folketrygden") or sykehus@noma.no (for pharmaceuticals to be funded by the  hospitals). It is important to include the following information in the e-mail text: Brand name/trade name, Active substance, and Nordic package number covered by the documentation.

The Norwegian Medicines Agency has prepared guidelines for the duty of confidentiality (STA) under the existing legislation .

 

 

Guidelines for the submission of documentation for single technology assessment (STA) of pharmaceuticalshttps://legemiddelverket.no/english/public-funding-and-pricing/documentation-for-sta/guidelines-for-the-submission-of-documentation-for-single-technology-assessment-sta-of-pharmaceuticalsGuidelines for the submission of documentation for single technology assessment (STA) of pharmaceuticalsThe current guidelines entered into force on 1 January 2018. 1933
Template for submission of documentation for the single technology assessment of pharmaceuticalshttps://legemiddelverket.no/english/public-funding-and-pricing/documentation-for-sta/template-for-submission-of-documentation-for-the-single-technology-assessment-of-pharmaceuticalsTemplate for submission of documentation for the single technology assessment of pharmaceuticals​Pharmaceutical companies must use this template when preparing documentation. 1935
Guidelines for pre-meetings in connection with single technology assessments (STAs)https://legemiddelverket.no/english/public-funding-and-pricing/documentation-for-sta/guidelines-for-pre-meetings-in-connection-with-single-technology-assessments-stasGuidelines for pre-meetings in connection with single technology assessments (STAs)Pre-meetings with the Norwegian Medicines Agency (NoMA) are not obligatory, but may be arranged on request. 1936Information to companies seeking guidance.
Pharmaceuticals for which the Regulation on Medicinal Products grants exceptions from the documentation requirements for single technology assessments (STAs)https://legemiddelverket.no/english/public-funding-and-pricing/documentation-for-sta/pharmaceuticals-for-which-the-regulation-on-medicinal-products-grants-exceptions-from-the-documentation-requirements-for-single-technology-assessments-stasPharmaceuticals for which the Regulation on Medicinal Products grants exceptions from the documentation requirements for single technology assessments (STAs)​The following includes information on which pharmaceuticals that this concerns and the documentation that pharmaceutical companies must submit in order for the pharmaceutical to be assessed for public sector financing. 1937Information on which pharmaceuticals that this concerns and the documentation necessary in order to be assessed for public sector financing.
Access to pharmaceuticals for very small patient groups with extremely severe conditionshttps://legemiddelverket.no/english/public-funding-and-pricing/documentation-for-sta/access-to-pharmaceuticals-for-very-small-patient-groups-with-extremely-severe-conditionsAccess to pharmaceuticals for very small patient groups with extremely severe conditions​The Norwegian Medicines Agency has prepared a memorandum that describes arrangements for the single technology assessment (STA) of pharmaceuticals for such patient groups. 1938
Unit cost databasehttps://legemiddelverket.no/english/public-funding-and-pricing/documentation-for-sta/unit-cost-databaseUnit cost database​This is a selection of frequently used unit costs that have been used in previously submitted health technology assessments (HTAs). 1939

Publisert: 16.01.2019

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