Notification of medicine shortages
Published:
|
Updated:
Changes
- : E-mail notification has been sent to make MAHs aware that NOMA on June 8 launched a new form for notification of medicine shortages.
- : Updated with new links to new notification forms and guidance to the forms.
- : Information regarding change of marketing status has been moved to another page.
- : Updated information and new form (with guidance) regarding notification of change in marketing status
Notification forms for pharmaceutical companies and information on reporting obligation. A new notification form was launched in June 2026.
Page contents
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
In June 2026 we launched a new notification form, which includes guiding questions to make reporting easier. The form is completed electronically, and the notifier receives a copy by email.
It is quicker to complete the form if you have the relevant information available in advance.
See overview of questions included in the form
Part 1
Information about the medicinal product
- Medicine(s) [search for the medicine in the medicines database]
- Tip: Searching by product number is preferred, but it is also possible to search by trade name, marketing authorisation holder, or marketing authorisation number.
- Shortage period (start- and end date)
- If the medicine is centrally approved (CP), has the shortage been reported to ESMP?
- Is the medicinal product covered by a procurement agreement with Sykehusinnkjøp?
- If Yes - Provide the name of the tender
Information about the shortage
- Is the shortage partial or complete?
- If Partial shortage – Specify in percentage how much of the demand you are unable to supply.
- What is the cause of shortage?
- Based on your assessment, could the shortage impact patients' access to the medicine(s)?
- If Yes or Not known, part 2 must be filled out as well.
Part 2:
- Where in the distribution chain has the issue occurred?
- Which market(s) are affected?
Information about implemented measure
- Which measure(s) have you implemented as part of your shortage mitigation and prevention plan?
- Can MAH supply foreign packages?
- If Yes – Estimated delivery date for foreign packages
- If No
- What is the reason you cannot supply foreign packages?
- Have other medicinal products approved under a different procedure been considered?
- If To be investigated – Please specify the date when you will have more information
- Do you have products with less than 6 months of shelf life available that can be used?
Submitting a notification
- The form can be used to report a shortage affecting up to 12 article numbers with the same product name and pharmaceutical formulation.
- Shortages affecting different pharmaceutical formulations require a separate form for each formulation.
- Information entered into the form is saved automatically. This means you can pause completion of the form and submit it later.
Any additional or updated information must be submitted as soon as possible. This is done by submitting a notification of updated shortages.
Which form should be used?
- Notification of new shortages: Use this form to report a new shortage or when the end date of a previously reported shortage period has passed.
- Notification of updated shortages: Use this form when the end date of a previously reported shortage period has not yet passed.
Notification form
Access to the notification form
To report a shortage, the notifier must create a user account in the Forms portal. Two-factor authentication is required. See the user guide here.