We prefer that all documentation is submitted electronically on a CD/USB-stick or by e-mail to email@example.com along with a short description of the submission. The following should be submitted:
- Covering letter with reference to EudraCT number and study title
- Application Form (EudraCT-form) signed by sponsor (scanned pdf file), and in XML. The application form can be found on the EudraCT home page.
- Protocol, see § 1-5 q) in the regulation
- Pharmaceutical-chemical documentation also for placebo
- Pre/non clinical documentation
- Clinical documentation
- Investigators Brochure
- Labeling proposal (according to Annex 13 of GMP)
- Copy of the EC decision if available
- Confirmation of signed insurance
- Pediatric Committees Final Summary Report for Pediatric Investigational Plan (PDCO Final Summary Report for PIP) if applicable
- A copy of the Scientific Advice from regulatory authorities, if applicable (ref. EudraCT point D.2.6)
- Preparedness in the event of complications, if not described in the protocol
There is a fee of 10.000 NOK for new applications. For substatial amendments the fee is 5000,- NOK. The Norwegian Medicines Agency will send an invoice to the Sponsor after validation of the clinical trial application. The EudraCT number and our reference number will be on the invoice and sent to the person who signed the EudraCT form unless the Sponsor inform the Agency otherwise. The fee shoud be paid 30 days after a vaild application.
Non-commercial sponsors will not be charged.