Regulatory fees valid from 1st 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.
Includes changes in the rate for Homeopathy; Application for registration, the fee covers all degrees of dilution of a pharmaceutical form
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.
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: firstname.lastname@example.org
Supplier tax - Medicinal Products 2022 (pdf)
Supplier tax report form 2022 (excel)
Supplier tax - Medicinal Products 2021 (pdf)
Supplier tax report form 2021 (excel)
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)