Notification of medicine shortages

It is important that patients get the medicines they need. Cooperation between the pharmaceutical industry and authorities is important when supply issues arise. The Norwegian pharmaceutical legislation has introduced a reporting obligation for temporary or permanent interruptions in the supply of medicines: Forskrift om legemidler § 8-6.

What does the reporting obligation entail?

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. The notification should be sent when the product cannot be delivered at the expected order volume from the wholesaler or upon request from NOMA.

From February 2025, notifications of medicine shortages must also be reported to EMA's ESMP (European Shortages Monitoring Platform). This applies to centrally authorized medicines and is in addition to the reporting obligations to national competent authorities/NOMA.

Notification of Medicine Shortage

• Notification of medicine shortage is used to report a new shortage or if the end date for a previous shortage period has passed.
• Notification of updated medicine shortage is used if the end date for a previous shortage period has not passed.

The form must be filled out electronically. The sender receives a copy of the submitted notification form by email.

Submission of notification

One form must be sent for each trade name per medicinal formulation. Up to 3 strengths for each medicinal formulation can be reported. For each strength, up to 5 package sizes can be reported.

Information on measures

It is assumed that an assessment has been made regarding whether the notifier can procure foreign packages. NOMA will contact if there is a need to use foreign packages.