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 2019

Applicable from 1.1.2020 in accordance with forskrift om legemidler (FOR 2009-12-18 nr 1839) § 15-3. The fee rates have been adjusted by 3.2% from 1.1.2020 in line with the state budget.

Please see the list containing the new regulatory fees valid from 1^st of January 2020

Please see the list containing the regulatory fees valid from 1^st of January till 31^st of December 2019

The fees are in Norwegian kroner (NOK).

For Marketing Authorisation Applications (MAA) in Decentralised (DCP) and Mutual Recognition procedure (MRP) a fee, at time of agreement for Norway to be RMS, has been introduced. If the application subsequently is withdrawn, this fee will not be reimbursed.

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:

Supplier tax - Medicinal Products 2020 (pdf)
Supplier tax report form 2020 (excel)

Supplier tax - Medicinal Products 2019 (pdf)
Supplier tax report form 2019 (excel)

Supplier tax - Medicinal Products 2018 (pdf)

Supplier tax report form 2018 (excel)

Control Fee - Medicinal Products 2017 (pdf)

Control Fee report form 2017 (excel)

Please send the form to: leverandoravgift@legemiddelverket.no