Regulatory fees

Regulatory fees

Applicable from 01.01.2026 in accordance with forskrift om legemidler til mennesker (FOR 2009-12-18 nr 1839) § 15-3, and forskrift om legemidler til dyr (FOR-2022-09-08-1573) § 12-4. The fee rates have been adjusted by 3.6 % from 01.01.2026 in line with the state budget.

Fees applicable for applications received after 01.01.2026

• Regulatory fees for human medicinal products valid from 1st of January 2026 (PDF)

• Regulatory fees for veterinary medicinal products valid from 1st of January 2026 (PDF)

The fees are in Norwegian kroner (NOK).

The Norwegian Medical Products Agency will invoice the fee on the basis of received application. The invoice will be issued to the billing address stated in the eAF.  Reference, such as PO-number, must be stated in the eAF. Payment is due at the latest within 30 days from date of invoice. 

Invoices can be issued in three alternatives:

• Electronically EHF (Elektronisk handelsformat),
• E-mail with a PDF-file to a registered e-mail address,
• via mail.

In specific cases the Norwegian Medical Products Agency may waive the required fee. If the applicant wishes to request a waiver or reduction of the fee, a justification must be enclosed to the application.

• Regulatory fees for human medicinal products valid from 01.01. 2025-31.12.2025 (PDF)

• Regulatory fees for veterinary medicinal products valid from 01.01.2025-31.12-2025 (PDF)

MAHs in the Norwegian market are liable to pay a supplier tax of 0.85 % of turn-over. More information on this page.