INOPP Forum
Pharmacovigilance Requirements in the Netherlands
Quote from VigiServe Admin on March 15, 2026, 12:00 PMIn the Netherlands, pharmacovigilance is fully integrated into the European Union framework and enforced by the College ter Beoordeling van Geneesmiddelen (CBG). All EU pharmacovigilance legislation applies directly, including Good Pharmacovigilance Practices, with no significant national deviations.
1. Clinical Safety (Clinical Trials)
Clinical trials fall under the EU Clinical Trials Regulation (CTR 536/2014) and require approval through the Clinical Trials Information System (CTIS).
Expedited Reporting: Sponsors must report Suspected Unexpected Serious Adverse Reactions (SUSARs) to EudraVigilance.
Fatal or Life-Threatening: Within 7 calendar days.
Other Serious Unexpected: Within 15 calendar days.
Periodic Reporting: Development Safety Update Reports (DSURs) are required annually.
Submission: Electronic submission via CTIS and EudraVigilance.
2. Post-Marketing Pharmacovigilance
Marketing Authorization Holders must maintain a pharmacovigilance system compliant with EU Good Pharmacovigilance Practices.
Personnel & Infrastructure:
Qualified Person for Pharmacovigilance: Mandatory. An EU-resident, qualified professional must be appointed and registered.
Pharmacovigilance System Master File: Mandatory. The file must be maintained and available for CBG inspections.
Incident Reporting (ICSRs):
Timelines:
Serious: Within 15 calendar days.
Non-Serious: Within 90 calendar days.
Submission: All reports go electronically to EudraVigilance.
Risk & Periodic Reporting:
Periodic Benefit-Risk Evaluation Reports: Mandatory. Frequency aligns with the EU EURD list (typically every six months initially, then annually).
Risk Management Plans: Mandatory for new active substances, biologics, and high-risk products.
Additional Monitoring: Medicines under intensive monitoring must display the black inverted triangle (▼) in the Summary of Product Characteristics and package leaflet.
Summary of Requirements
Component Requirement in the Netherlands Regulatory Authority CBG (College ter Beoordeling van Geneesmiddelen) Framework EU Good Pharmacovigilance Practices / Medicinal Products Act Local Qualified Person for Pharmacovigilance Yes (EU Qualified Person) Pharmacovigilance System Master File Yes Safety Reporting 15 days (Serious) / 90 days (Non-Serious) Clinical Reporting SUSARs (7/15 days - EU CTR) Submission Language Dutch / English
In the Netherlands, pharmacovigilance is fully integrated into the European Union framework and enforced by the College ter Beoordeling van Geneesmiddelen (CBG). All EU pharmacovigilance legislation applies directly, including Good Pharmacovigilance Practices, with no significant national deviations.
1. Clinical Safety (Clinical Trials)
Clinical trials fall under the EU Clinical Trials Regulation (CTR 536/2014) and require approval through the Clinical Trials Information System (CTIS).
-
Expedited Reporting: Sponsors must report Suspected Unexpected Serious Adverse Reactions (SUSARs) to EudraVigilance.
-
Fatal or Life-Threatening: Within 7 calendar days.
-
Other Serious Unexpected: Within 15 calendar days.
-
-
Periodic Reporting: Development Safety Update Reports (DSURs) are required annually.
-
Submission: Electronic submission via CTIS and EudraVigilance.
2. Post-Marketing Pharmacovigilance
Marketing Authorization Holders must maintain a pharmacovigilance system compliant with EU Good Pharmacovigilance Practices.
-
Personnel & Infrastructure:
-
Qualified Person for Pharmacovigilance: Mandatory. An EU-resident, qualified professional must be appointed and registered.
-
Pharmacovigilance System Master File: Mandatory. The file must be maintained and available for CBG inspections.
-
-
Incident Reporting (ICSRs):
-
Timelines:
-
Serious: Within 15 calendar days.
-
Non-Serious: Within 90 calendar days.
-
-
Submission: All reports go electronically to EudraVigilance.
-
-
Risk & Periodic Reporting:
-
Periodic Benefit-Risk Evaluation Reports: Mandatory. Frequency aligns with the EU EURD list (typically every six months initially, then annually).
-
Risk Management Plans: Mandatory for new active substances, biologics, and high-risk products.
-
Additional Monitoring: Medicines under intensive monitoring must display the black inverted triangle (▼) in the Summary of Product Characteristics and package leaflet.
-
Summary of Requirements
| Component | Requirement in the Netherlands |
| Regulatory Authority | CBG (College ter Beoordeling van Geneesmiddelen) |
| Framework | EU Good Pharmacovigilance Practices / Medicinal Products Act |
| Local Qualified Person for Pharmacovigilance | Yes (EU Qualified Person) |
| Pharmacovigilance System Master File | Yes |
| Safety Reporting | 15 days (Serious) / 90 days (Non-Serious) |
| Clinical Reporting | SUSARs (7/15 days - EU CTR) |
| Submission Language | Dutch / English |