Netherlands

Pharmacovigilance in the Netherlands is regulated by the College ter Beoordeling van Geneesmiddelen (CBG-MEB), with inspections performed by the Inspectie Gezondheidszorg en Jeugd (IGJ); the Netherlands Pharmacovigilance Centre Lareb supports national adverse-reaction collection and analysis. MAHs must operate an EU-compliant system with an EU/EEA QPPV and Union PSMF. A national pharmacovigilance contact person must be registered with CBG-MEB when the EU QPPV is outside the Netherlands or cannot read, write and speak Dutch, with appropriate medical access and backup. EudraVigilance ICSR deadlines are 15 calendar days for serious and 90 days for non-serious cases. PSUR/PBRER submissions, RMPs, risk-minimisation measures and signal management follow EU rules and authorisation conditions. CBG-MEB's pharmacovigilance and risk-management systems information explains the continuing MAH duties, while IGJ conducts risk-based or triggered inspections covering reporting, signals, the PSMF and the quality system. As an EU/EEA jurisdiction, the EU pharmacovigilance framework applies to the EU QPPV and Union PSMF, EudraVigilance ICSR reporting, applicable PSURs, RMPs, signal management, quality-system audits and competent-authority inspections. MAHs should also check current national submission channels, contact arrangements and language requirements. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Difference in QPPV Nomination Between EU and KSA; PSMF Maintenance: Concept and Importance in Pharmacovigilance.