Business.gov.nl
Logo of the Dutch governmentGo to homepage

Government information for entrepreneurs

Reporting side effects of medicines

This information is provided by

Netherlands Enterprise Agency, RVO

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 LarebExternal link. Serious side effects are those side effects that result, for example, in:

  • hospitalisation
  • prolongation of hospitalisation
  • congenital defects
  • occupational disability or invalidity
  • life-threatening situations
  • death

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 InspectorateExternal link (IGZ, in Dutch). This includes defects in the packaging, patient leaflet or the product itself.

This information is provided by

Netherlands Enterprise Agency, RVO