Fees for assessment of clinical trials and assessment of safety information
Published:
Changes
The fees are applicable from January 1st 2023
| Type of application | Fee |
| New application - Norway as Reference Member State | 73.080 NOK |
| New application - Norway as Member State Concerned | 31.320 NOK |
| Application for Substantial Modification | 6264 NOK |
| Application for transition to regulation no. 536/2014 | No fee |
| Safety assessment - time spent > 5 days | 4176 NOK |
| Safety assessment - time spent < 5 days | 2088 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.