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 (in Dutch). 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 quality defect in a medicine, you must notify the Health Care Inspectorate (IGZ, in Dutch). This could be a defect with regard to the packaging, patient leaflet or the product itself.