ForsideEnglishRegulatory affairsRegulatory Fees 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. SideinnholdRegulatory fees valid from 1st of January 2022Applicable from 1.1.2022 in accordance with forskrift om legemidler (FOR 2009-12-18 nr 1839) § 15-3. The fee rates have been adjusted by 2.1 % from 1.1.2022 in line with the state budget.List of new regulatory fees valid from 1st of January 2022 Regulatory fees for veterinary medicinal products (VMPs) List of regulatory fees valid from 1st of January 2021 till 31st of December 2021 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 If the application subsequently is withdrawn, this fee will not be reimbursed.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 TaxControl 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: Supplier tax - Medicinal Products 2023 (pdf)Supplier tax report form 2023 (excel) Please send the form to: leverandoravgift@legemiddelverket.no Earlier years: 2022Supplier tax - Medicinal Products 2022 (pdf)Supplier tax report form 2022 (excel)2021Supplier tax - Medicinal Products 2021 (pdf)Supplier tax report form 2021 (excel)2020Supplier tax - Medicinal Products 2020 (pdf) Supplier tax report form 2020 (excel) 2019Supplier tax - Medicinal Products 2019 (pdf) Supplier tax report form 2019 (excel) 2018Supplier tax - Medicinal Products 2018 (pdf)Supplier tax report form 2018 (excel) 2017Control Fee - Medicinal Products 2017 (pdf)Control Fee report form 2017 (excel) Oppdatert: 24.01.2022 Publisert: 13.09.2016 Fant du det du lette etter? Ja Ja Nei Nei Så bra! Hva var det du lette etter på denne siden? Kan du fortelle hva du ikke fant? Vennligst ikke oppgi navn eller kontaktinformasjon i dette feltet, men send oss en e-post hvis du har konkrete spørsmål. Send inn tilbakemelding Skriv ut