Wijziging van de Geneesmiddelenwet ter implementatie van richtlijn 2012/26/EU, wat de geneesmiddelenbewaking betreft

This Dutch bill amends the Medicines Act (Geneesmiddelenwet) to transpose Directive 2012/26/EU into national law, focusing on pharmacovigilance, the monitoring of medicines' safety after they reach the market. The directive strengthens how side effects are reported, assessed and communicated, so that risks are detected earlier. The changes mainly affect pharmaceutical companies holding marketing authorisations, healthcare professionals who report adverse reactions, and patients who use medicines in the Netherlands. Regulators such as the medicines agency are also affected by new reporting and oversight duties. This summary is based on metadata only, not the full legislative text.