Temporarily supply of a medicinal product in a different packaging

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 Medicines Evaluation Board (MEB) 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 different packaging*:

  1. The shortage is affecting a medicinal product registered nationally or Europe-wide for human use, intended for supply in the Netherlands.
  2. 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.
  3. The replacement product comes from an EEA country. Other than its packaging, it is identical in all respects to the licensed product in the Netherlands.
  4. The location at which the replacement product is produced is the same as that of the product licensed in the Netherlands.
  5. 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.
  6. If it involves a nationally licensed medicinal product, then the 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.
  7. The modification of the packaging will be done by the holder of a manufacturer’s permit.
  8. It is for a limited period (generally no longer than 3 months).

* = Deviations from this are possible (in consultation) for medicinal products that are only intended for intramural use.

For published decisions from the MEB on temporarily supply of a medicinal product in a different packaging, see this page (in Dutch)