Notification of product defects and recalls
The Health and Youth Care Inspectorate (IGJ) receives notifications about product defects in medicines via the Medicine Shortages and Defects Notification Centre. A quality defect in a medicinal product that is on the market can result in serious harm being done to patients.
Reporting product defects
Anyone who puts a medicinal product on the market in the Netherlands is obliged to report quality defects to the Dutch Healthcare Inspectorate (IGZ) and the MEB. In addition, pharmacists for instance can also submit a notification. Reports can be addressed to the Medicine Shortages and Defects Notification Centre.
When a notification is submitted, the inspector immediately decides if there is a risk to public health. Because a medicinal product may sometimes have to be withdrawn urgently from the market, an inspector is always available for the purpose.
Whether or not a recall is required depends on the classification of the risk. The classification also determines whether the recall is done at the:
- patient level
- pharmacy level
- wholesaler level
The classification also determines whether foreign inspectorates are informed.
A notification often does not require a recall. The risk is then not serious, whereas a recall can in fact generate major risks for the availability of the medicinal product.
If the inspectorate does consider a recall, it will first consult the marketing authorisation holder. We do not carry out the recall ourselves. That is something that the marketing authorisation holder must do. They do however have to present the recall letter to us first.
Sending a recall letter
A recall letter must be sent in special Orange Hand envelopes. Because such envelopes are only used for recalling medicinal products, pharmacists’ attention is drawn to them especially. The Orange Hand Envelop Procedure (in Dutch) can be found on the Association Innovative Medicines website. This is also where the envelopes and the requisite address files can be obtained.
Notifications from abroad
We also receive notifications from foreign inspectorates. These are about medicinal products that are on the market in Europe and the United States and therefore possibly in the Netherlands too. We analyse the notifications every year and use them to prioritise our inspection activities.