In 2019, the Norwegian Medicines Agency received 1300 notifications of shortages of medicinal products (including veterinary preparations) in Norway. Increased caseload over time has led to the need to digitize enrollment and registration of interruptions.
Therefore, the Norwegian Medicines Agency is now introducing electronic notification forms that market authorisation holders should use when submitting notificatrions of new and extended shortages. Electronic notification forms will make it easier to report shortages and the information will be standardized and more transparent.
The Norwegian Medicines Agency encourages all market authorisation holders to use the new forms as soon as possible. As of July 1st 2020, we will no longer accept English notifications of shortages in word format.
MA holders that are not located in Norway should use English notification forms when reporting shortages. This also applies to MA holders located in Sweden and Denmark.
Notification of up to 3 strengths in the same form
Up to 3 strengths of 5 package sizes for a dosage form can be reported in the notification form. When submitting a form, the sender will receive a receipt by e-mail with an overview of reported information.
The market authorisation holder is required to register ATC code for each dosage form. In addition, there are requirements for mandatory information in marked fields in the form. The information must be as complete as possible to make it easier for the The Norwegian Medicines Agency to assess the shortage situation quickly.
Separate notification forms for new and extended interruptions
- The form "Notification of new shortages" should be used to report new out of stock situations or if the end date for a previous shortage period has passed.
- The form "Notification of extended shortages" should be used if the notification is sent before the end date stated by the market aut holder for the ongoing shortage for the same package size /medicinal product.
See more detailed information with form links.
Form for application of foreign packages
If the MA holder can obtain foreign packages during out of stock situation, use the following form to apply for license