If you work as a doctor or pharmacist in the Netherlands, you must report serious side effects of registered medicines to the Netherlands Pharmacovigilance Centre Lareb. Serious side effects are those side effects that result, for example, in:
- prolongation of hospitalisation
- congenital defects
- occupational disability or invalidity
- life-threatening situations
Notification of quality defects in medicines
If you, as a pharmacist, discover a defect in quality of a medicine, you must notify the Health Care Inspectorate (IGZ, in Dutch). This includes defects in the packaging, patient leaflet or the product itself.