At the Medicine shortages and defects notification centre, marketing authorisation holders and manufacturers can submit the following notifications:
- Notification that a medicinal product is being placed on the market for the first time
- Revoke a previously made notification of a supply problem because it will not occur
- Change a previously made notification of a supply problem
- Notification that the marketing of a medicinal product is being discontinued or interrupted
- Notification that a medicinal product is being placed on the market in smaller quantities or to an insufficient degree
- Notification of a quality defect in relation to a medicinal product
- Notification of an out-of-specification in relation to an advanced therapeutic medicinal product (ATMP)
Notifications of a quality defect and an out-of-specification of an ATMP can also be submitted by manufacturers (including compounding and collegiate dispensing pharmacies).
To do this, you can use the notification form. The user guide and the frequently asked questions page contain more details on the reporting procedures.
Coordination
The Medicine shortages and defects notification centre is coordinated by the Medicines Evaluation Board (MEB) and the Health and Youth Care Inspectorate (IGJ). The notification centre is commissioned by the Ministry of Health, Welfare and Sport (VWS).
Notifications from patients, pharmacists, wholesalers and health care providers
This notification centre is only intended for the above notifications by pharmaceutical companies.
Are you a patient and you wish to submit a notification about the quality of care? Then you can contact the National Health Care Report Centre. You can report adverse events caused by medicinal products to the Netherlands Pharmacovigilance Centre Lareb.
Are you a pharmacist or wholesaler and you have detected a medicine shortage or quality defect (caused by another party)?
- You can directly notify the medicine's marketing authorisation holder about a quality defect. The marketing authorisation holder subsequently reports this quality defect to the Medicine shortages and defects notification centre.
- You can notify KNMP Farmanco of a medicine shortage in order to inform your colleagues. Pharmacists also notify their wholesaler about a shortage. If wholesalers also experience a shortage, they notify the marketing authorisation holder. In case a shortage also exists at other wholesalers, the marketing authorisation holder submits a notification at the Medicine shortages and defects notification centre and makes an estimate whether there are sufficient alternatives.
- If you are not satisfied with the way your notification or complaint has been dealt with by the marketing authorisation holder, you can report this to the Health and Youth Care Inspectorate (IGJ).
Are you a health care provider and do you have a question or wish to submit a notification about the quality of care? Then you can contact the Health and Youth Care Inspectorate (IGJ). You can report adverse events caused by medicinal products to the Netherlands Pharmacovigilance Centre Lareb.
