Fees for assessment of clinical trials and assessment of safety information
The fees are applicable from January 1st 2023
|Type of application||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|
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)
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.