Notification of medicine shortages
Published:
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Updated:
Changes
- : 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.
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 holder of the marketing authorisation 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 must be sent when a product cannot be delivered on order from wholesalers, or upon request from NOMA.
In addition, notification must be sent to The European Medicines Agency (EMA) if the reason for the interruption is because:
- the medicine is harmful
- the medicine has no therapeutic effect
- the benefit/risk ratio is not positive
- the qualitative and/or quantitative composition of the medicine is not as stated in the labeling or
- the control of the medicine and its ingredients, production, or other conditions significant for the marketing authorisation, are not in accordance with the requirements of the legislation.
Notification of Medicine Shortage
The form for new medicine shortage is used to report a new shortage or if the end date for a previous shortage period has passed. The form for 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.