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Fees for assessment of clinical trials and assessment of safety information

Published:

Changes

The fees are applicable from January 1st 2023

Type of applic​​​ation Fee
​New application - Norway as Reference Member State 70.000 NOK
New application - Norway as Member State Concerned 30.000 NOK
Application for Substantial Modification 6000 NOK
Application for transition to regulation no. 536/2014 No fee
Safety assessment - time spent > 5 days 4000 NOK
Safety assessment - time spent < 5 days 2000 NOK

Applications

Non-commercial sponsors will not be charged for a fee.

Invoice information must be uploaded to the application Dossier in CTIS ("proof of payment" in the Forms section)

Safety assessments

NoMA will send the sponsor an invoice once the annual safety report (ASR) is received.  In case NoMA receives several ASRs for the same active substance by different sponsors, all sponsors will be charged separately.

Non-commercial sponsors will not be charged.

Contact us

Unit for clinical trials and innovation

+47 22 89 77 00

klut@noma.no