Reporting side effects of medicines

Do you work with medicines in the Netherlands? You must report serious side effects of registered medicines. The Medicines Evaluation Board (College ter Beoordeling van Geneesmiddelen, CBG) checks the quality, effectiveness, and safety of medicines.

In case of reports of serious side effects, CBG can:

• take the medicine off the market
• impose stricter rules on who is allowed to take the medication
• list the side effects on the package leaflet
• make screening on possible serious side effects mandatory

Reporting by traders

Do you trade medicines and do you have a permit? 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
• Mild side effects within 90 days of learning about

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

Serious side effects of medicines

Serious side effects of medicines are those side effects that result in, for example:

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

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 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

Do you know of any side effects of an implant? You should report them 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).

Notification of quality defects in medicines

Do you, as a pharmacist, 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 permit holder. They will then have to report to the Medicine shortages and defects notification centre.