The Norwegian Environment Agency, The Norwegian Directorate for Health and The Norwegian Medicines Agency have established a common mailbox for applications for approval of medicinal products containing GMO for clinical trials. The Norwegian Medicines Agency operates this mailbox.
All applications for approval to the various authorities should be sent at the same time to this mailbox, to allow the authorities to start the evaluation of the applications at the same time, and in this way facilitate the approval under all regulations before the planned start-up of the clinical trial.
Digital submission
Applications are preferably submitted via Eudralink. It is safe file transfer system managed by the European Medicines Agency, EMA. You can use the system via this link:
The Eudralink is submitted to the shared mailbox:
Submission per e-mail
The application can also be submitted directly by e-mail to:
Submission of applications by e-mail is at your own risk.
Submission per postal service
If you prefer to send an application by post, it can be sent to the Norwegian Medicines Agency:
Norwegian Medicines Agency
PO Box 240 Skøyen
0213 Oslo, Norway
Label application and documentation with "GMO for deliberate release".