Regulatory fee and supplier tax

Holders of marketing authorisations (MAH) have to pay a regulatory fee when they apply for marketing authorisation. MAHs in the Norwegian market are also liable to pay a supplier tax of 1.0 % of turn-over.

Regulatory fees valid from 1^st of January 2023

Applicable from 1.1.2023 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 3,0 % from 1.1.2023 in line with the state budget.

Regulatory fee for human medicinal products valid from 1st of January 2023

Includes changes in the rate of Homeopathy; Application for registration, the fee covers all degrees of dilution of a pharmaceutical form, as well as inserted fee on Clinical trials pursuant to new Regulation 536/2014.

Regulatory fee for veterinary medicinal products valid from 1st of January 2023

Includes changes in the rate for Homeopathy; Application for registration, the fee covers all degrees of dilution of a pharmaceutical form

List of new regulatory fees valid from 1stof January till 31st of December 2022

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 Medicines Agency before submission.

The Norwegian Medicines 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 medicines Agency may waive the required fee.

Supplier Tax

Control fee is called supplier tax from 01st of July 2018.

The tax covers expenses for quality control, supervision of adverse events and information activities by the authorities. The Norwegian Medicines Agency collects the tax.

Guidelines for 2023:

Please send the form to: leverandoravgift@legemiddelverket.no