
The Netherlands
As of 25 October 2024, a new version of the notification form of the “Meldpunt geneesmiddelentekorten en -defecten” will become available. The new form will include the following changes:
- The addition of the option to adjust the period indication of a previous shortage notification. As a result, it is no longer necessary to submit a new notification when the period of the supply interruption changes.
- The notification process for placing a product on the market again following a supply interruption has been changed: this can be reported by changing the end date of the supply interruption (see above). If the specified end date of the notification is correct, there is no need to submit a new notification. The notification type ‘A notification that a medicinal product is placed on the market for the first time, or again following an interruption’ has therefore been shortened to ‘Notification that a medicinal product is being placed on the market for the first time’.
- The addition of the option to provide estimates on the duration of the supply interruption and market share when this is not known exactly.
- The addition of the option to request the temporary supply of a product in a different packaging. As a result, requests can be processed more quickly with less e-mail traffic between the reporting party and the MEB.
- The addition of extra questions when reporting a quality defect, making the role for the Netherlands immediately clear.
- The addition of an additional type of notification “out-of-specification for an advanced therapeutic medicinal product (ATMP)”.
The changes will be described in more detail in a user manual and a FAQ list that will be available on the website. Any queries related to the new version of the form can be addressed to beschikbaarheid@cbg-meb.nl.