Revised notification form for medicine shortages and defects
News item28-10-2024 | 10:00
The notification form of the Medicine Shortages and Defects Notification Centre has been made more user-friendly. The marketing authorisation holders that submit notifications contributed to the revision process.
The Medicine shortages and defects notification centre offers a central location for marketing authorisation holders and manufacturers to submit various notifications. By implementing these changes, the Medicine shortages and defects notification centre continues its efforts to enhance the user-friendliness and effectiveness of the notification process.
Changes in the notification form
The updated form enables notifiers to estimate the duration of supply interruptions and market share when exact data is not available. Additionally, notifiers can now request the temporary supply of a product in alternative packaging (“TAV”). This enables requests to be processed more swiftly, thereby reducing the volume of email correspondence.
The changes are described in greater detail in the user guide and the frequently asked questions, available on the website of the Medicine shortages and defects notification centre.
The updated form has been available as from Friday 25 October 2024 .The previous version of the form may be used until 30 November 2024.
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)".
