Regulatory fees valid from 1st of January 2018
Referring to the Norwegian legislation, "Forskrift om legemidler" of December 18 2009 §15-3, the fees were updated on January the 1st 2018.
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 If the application subsequently is withdrawn, this fee will not be reimbursed.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 2018 (pdf)
Supplier tax report form 2018 (excel)
See the Guidelines for Control Fee - Medicinal Products 2017 (pdf)
Control Fee report form 2017 (excel)
See the Guidelines for Control Fee - Medicinal Products 2016 (pdf)
Control Fee report form 2016 (excel)
Please send the form to: leverandoravgift@legemiddelverket.no
