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New notification form for medicine shortages

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Changes

In collaboration with the pharmaceutical industry, we have developed a new notification form that makes reporting easier.

The new solution is also designed to encourage pharmaceutical companies to share more information and provide useful insights, helping ensure that measures are as targeted and effective as possible.

The new form is more user-friendly and easier to complete. Product information is populated automatically when users search by, for example, product number, medicine name or active substance. The form also provides more opportunities to share information than before. Additional free-text fields and an improved workflow make it easier to provide detailed information about the specific situation.

Strong collaboration

The new form has been developed in cooperation with the Norwegian Association of Pharmaceutical Manufacturers (LMI) and Farma Norge.

“We have had excellent cooperation throughout the project and received valuable support from several companies during testing. We are now looking forward to putting the new form into use. It is particularly important that companies share more information with us, including their assessments of potential consequences for patients and any mitigation measures they have implemented. The more serious the situation, the more information we need,” says Senior Medical Adviser Ingrid Aas at the Norwegian Medical Products Agency (NOMA).

This autumn, NOMA will invite stakeholders to a seminar to share experiences and gather feedback from users.

Important to notify

Marketing authorisation holders are legally required to notify NOMA no later than two months before an interruption in supply is expected to occur. However, very few notifications are submitted within this deadline, for various reasons. Many notifications are received only on the day the shortage becomes a reality.

“We recognise that it is not always possible to anticipate supply disruptions. However, in 2025 almost none of the notifications were submitted within the required deadline. This is clearly not satisfactory, and we expect compliance to improve going forward,” Aas points out.

NOMA assesses appropriate measures and provides information to the healthcare sector on how to manage the situation, ensuring that patients receive the treatment they need. Early notification is therefore essential, as it allows measures to be prepared in advance.

What is new?

  • The notification solution is more secure and requires two-factor authentication. Users must create an account.
  • Notifications can be saved and completed later (section by section/page by page).
  • Response options relating to the causes of supply problems have been harmonised with EMA’s shortage notification form.
  • New fields request information about measures taken by the company. For example, it is useful for NOMA to know whether production capacity can be increased.
  • New fields request the company’s own assessment of the criticality of the situation, including potential consequences for patients.
  • A new question asks whether the medicine is covered by a procurement agreement with Sykehusinnkjøp (the Norwegian Hospital Procurement Trust).
  • Additional free-text fields provide greater opportunities to share relevant information.

A single notification can still cover up to 12 different product numbers under the same trade name and pharmaceutical form.

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