Type of applic​​​ation
Fee
​New application - Norway as Reference Member State70.000 NOK
New application - Norway as Member State Concerned30.000 NOK
Application for Substantial Modification6000 NOK
Safety assessment - time spent > 5 days4000 NOK
Safety assessment - time spent < 5 days2000 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.

Publisert: 09.03.2023

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