Notification of an interruption on the market or a shortage
You can notify interruptions or terminations of a medicinal product on the market to the Medicine Shortages and Defects Notification Centre. This is also where notification of any shortages can be given.
If necessary, you may temporarily supply a medicinal product in a different packaging. The Dutch Health and Youth Care Inspectorate (IGJ) has to give permission for this. A request to that end can also be submitted using the notification form of the Medicine Shortages and Defects Notification Centre.
Conditions for permission
The following conditions are generally imposed for giving permission for a medicinal product to be supplied temporarily in a different packaging. Deviations from this are possible (in consultation) for medicinal products that are only intended for intramural use.
- The shortage is affecting a medicinal product registered nationally or Europe-wide for human use, intended for supply in the Netherlands.
- The availability of the product in question is needed for the continuity of patient care and there is no suitable medication alternative for the product on the market in the Netherlands.
- The replacement product is identical in all respects other than its packaging to the licensed product in the Netherlands.
- The location at which the replacement product is produced is the same as that of the product licensed in the Netherlands.
- It only involves a small batch for a limited period (generally no longer than 3 months).
- The packaging will be given a Dutch patient information leaflet or a copy of the registered package leaflet text for the Netherlands will be supplied with it.
- If it involves a nationally licensed medicinal product, then outer packaging will be given a label with the RVG (medicines registry) number, the Dutch product name and the name and registered office of the authorisation holder.
- The modification of the packaging will be done by the holder of a manufacturer’s permit (to be specified further at that time).
Rejections and objections
We will reject requests that are made for purely commercial reasons, such as insufficient sales of the product in the Netherlands. The authorisation holder will be notified of the rejection by e-mail. Because this is a procedure that is not based on the Dutch Medicines Act, it is not possible to lodge an objection against the rejection.