Pharmaceuticals granted 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.

Before a new pharmaceutical (or a new indication) can be funded by the public sector, an HTA must be carried out based on documentation submitted by the pharmaceutical company. Section 14-4 of the Regulation on Medicinal Products describes the key aspects of the documentation that must be submitted.

A derogation is made in Section 14-4, third paragraph, from the documentation requirements for the following categories if it can be documented that use of the pharmaceutical will not lead to either a change in benefit or an increase in resource use:

• New pharmaceutical form
• New strength
• Generic pharmaceuticals
• Bioequivalent pharmaceuticals

Pharmaceuticals which fall under these categories and which are appropriate for funding either via the National Insurance scheme (pre-approved reimbursement) or via he health authorities (Specialist Health Service):

 Fill in the price information and price application form (excel) (Prisopplysnings- og prissøknadsskjema), excluding column L.