Fee
Clinical trials initiated by the pharmaceutical industry
According to the regulation (unfortunately only in Norwegian) of December 22nd 1999 of medicinal products § 15-3 the Norwegian Medicines Agency requires a fee for evaluations of clinical trials on medicinal products.
- The amount for evaluation of a clinical trial is NOK 10 000.
- Trials not initiated by the industry is released from this fee.
- The Norwegian Medicines Agency will make out an invoice after receiving the application for a new clinical trial. The invoice will contain the EudraCT number and the Norwegian Medicines Agency reference number, and will be submitted to the party who signed the EudraCT form. Term of payment is within 30 days after the study was confirmed to be valid. The application will not receive an approval until payment has been confirmed.
- Evaluation of substantial amendments requires a fee of NOK 5 000.
Sist gjennomgått: 24.02.2009
Første gang publisert: 14.12.2005