Reporting side effects of medicines
Do you work with medicines in the Netherlands, for example as a doctor, pharmacist, or a marketing authorisation holder (trader)? You must report side effects of registered medicines.
In the Netherlands, the Medicines Evaluation Board MEB (College ter Beoordeling van Geneesmiddelen, CBG) checks the quality, effectiveness, and safety of medicines.
In case of reports of serious side effects, the MEB can:
- take the medicine off the market
- impose stricter rules on who is allowed to take the medication
- have the side effects listed on the package leaflet
- make screening on possible serious side effects mandatory
Reporting side effects by traders
Do you trade medicines and do you have a marketing authorisationt? You have to report any side effects of your medicines to the medicines authorities. You report:
- serious side effects within 15 days of learning about them
- mild side effects within 90 days of learning about them
You can also report serious side effects to the Netherlands Pharmacovigilance Centre Lareb. Reporting to Lareb is not mandatory, but it helps improve medicine safety (in Dutch).
What are serious side effects of medicines?
Serious side effects of medicines are adverse drug reactions (ADRs) that result in, for example:
- hospitalisation
- prolongation of hospitalisation
- life-threatening situations
- death
- congenital defects
- occupational disability or invalidity
Reporting side effects by doctors and pharmacists
If you are a doctor or pharmacist, you can report to Lareb (in Dutch). They will pass on important information about side effects to the MEB.
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
Do you know of any side effects of an implant? You have to report these to the Dutch Reporting Centre for Adverse Effects of Medical Implants (Meldpunt Bijwerkingen Implantaten, MEBI, in Dutch) of the National Institute for Public Health and the Environment (RIVM).
Notifying quality defects in medicines
Are you a pharmacist and do you discover a defect in quality of a medicine? For example, a defect in the packaging, patient leaflet, or the product itself? Then you must notify the marketing authorisation holder of that medicine. The marketing authorisation holder must then report to the Medicine shortages and defects notification centre.