Regulatory fees
Regulatory fees, applicable from 2010.10.01.
According to the Norwegian legislation, ”Forskrift om legemidler” of 22. December 1999 § 15-3, the fees are being updated by the 2010.10. 01
Differentiated fees for products applied via the Mutual recognition Procedure (MRP), and the Decentralised procedure (DCP) are introduced.
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 will be 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 who 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.
The figures are in Norwegian “kroner” (NOK).
Controll Fee, Norway
In accordance with The Regulation Relating to Medicinal Products of December 18th 2009, the Norwegian Medicines Agency collects a control fee from holders of marketing authorizations (MA).
Control Fee Medicinal Products – Guidelines
(Pdf)
Control Fee report form
(xlsx)
Sist gjennomgått: 20.01.2011
Første gang publisert: 08.03.2010