Regulatory fees

Regulatory fees

Applicable from 01.01.2025 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 3.8 % from 01.01.2025 in line with the state budget.

Fees applicable for applications recieved after 01.01.2025

• Regulatory fee for human medicinal products valid from 1st of January 2025 (PDF)

• Regulatory fee for veterinary medicinal products valid from 1st of January 2025 (PDF)

The fees are in Norwegian kroner (NOK).

For grouped variations, according to Variation Regulation EC 1234/2008, the fee will be equal to the sum of each variation applicable for a fee.

For products intended for MUMS (Minor Use/Minor Species) there is a 50 % reduction in the fee. MUMS-status must be clarified with the Norwegian Medical Products Agency before submission.

The Norwegian Medical Products Agency will invoice the fee on the basis of received application. Please note that we invoice the company that submits the application, should no other receiver be stated in the cover letter. Reference, such as PO-number, must be stated in the cover letter. Payment is due at the latest within 30 days from date of invoice.

In specific cases the Norwegian Medical Products Agency may waive the required fee.

Invoices can be issued in three alternatives: 1) Electronically EHF (Elektronisk handelsformat), 2) e-mail with a PDF-file to a registered e-mail address, or 3) via mail.

• Regulatory fee for human medicinal products valid from 01.01. 2024-31.12.2024 (PDF)

• Regulatory fee for veterinary medicinal products valid from 01.01.2024-31.12-2024 (PDF)

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