Information for marketing authorisation holders regarding medicine shortages
Published:
Changes
Notification of medicine shortages
The marketing authorisation holder must notify the authorities at least two months before an interruption in supply. In all cases, the notification must be sent as soon as possible.
For more information regarding reporting obligation and how to report to NOMA.
Shortcuts to notification
Application for license to sell foreign packages
NOMA can make excemptions to the requirement of a Norwegian marketing authorization when marketing interruption consequences would affect public health.
For more information regarding application form and how to apply.