Reporting side effects of medicines

This information is provided by

Netherlands Enterprise Agency, RVO

If you work with medicines in the Netherlands, you must report serious side effects of registered medicines. The Medicines Evaluation Board (CBG) checks the quality, effectiveness and safety of medicines. Depending on the gravity of potential side effects, the CBG can decide to take the following actions:

  • Take the medicine off the market
  • Impose stricter rules on who is allowed to take the medication
  • List the side effects on the package leafletExternal link
  • Make screening on possible serious side effects mandatory

In addition, you can report serious side effects to the Netherlands Pharmacovigilance Centre LarebExternal link. This is not obligatory, but reporting improves medicine safety.

Reporting by traders

Do you trade medicines and do you have a permit? You should report External link(pdf) any side effects of your medicines to the medicines authorities. Once you find out about them, you report:

  • Serious side effects within 15 days
  • Mild side effects within 90 days

Serious side effects

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

Reporting by doctors and pharmacists

If you are a doctor or pharmacist, you report to Lareb. They will pass on important information about side effects to the CBG. You report side effects that:

  • You think patients and carers should know about
  • Occur when your patient swaps medicine brand
  • Are already listed in the package leaflet
  • Occur in either prescription or over-the-counter medication
  • Are found in other health products, such as vitamin supplements, herbal remedies or slimming products

Reporting side effects of implants

If you know of any side effects of an implant, you should report them to the Dutch Reporting Centre for Adverse Effects of Medical ImplantsExternal link (Meldpunt Bijwerkingen Implantaten, MEBI, in Dutch) of the National Institute for Public Health and the Environment (RIVM).

Notification of quality defects in medicines

If you, as a pharmacist, discover a defect in quality of a medicine, you must notify the permit holder. They will then have to report to the Medicine shortages and defects notification centreExternal link. This includes defects in the packaging, patient leaflet or the product itself.

This information is provided by

Netherlands Enterprise Agency, RVO