Your Local Pharmacovigilance Partner for Drug Safety in Netherlands
DDReg provides pharmacovigilance services in Netherlands for pharmaceutical marketing authorisation holders. Our team operates as MEB-registered national contact person when QPPV resides outside Netherlands or lacks Dutch fluency, coordinates Lareb spontaneous reporting, manages EudraVigilance submissions, and delivers pharmacovigilance outsourcing Netherlands mandates for marketed products.
Netherlands Pharmacovigilance Framework
The Medicines Evaluation Board (MEB; College ter Beoordeling van Geneesmiddelen or CBG) is the Dutch national competent authority for pharmacovigilance. MEB implements the EU pharmacovigilance framework under Article 76a, Chapter 8 of the Dutch Medicines Act. All MAHs must appoint an EU QPPV and notify changes through the Article 57 database.
If the EU QPPV is resident outside the Netherlands or is not fluent in Dutch, MAHs must appoint a national contact person and register this person with MEB at the moment the MAH will market a product in the Netherlands. The national contact should maintain contact with the QPPV on pharmacovigilance duties, have a documented back-up procedure, and possess a medical qualification or direct access to someone with such qualifications per MEB and IGJ guidance. The Netherlands Pharmacovigilance Centre Lareb manages the national spontaneous reporting system and forwards reports to EudraVigilance.
Pharmacovigilance Outsourcing Netherlands - DDReg Services
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MEB National Contact Person and Registration
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Adverse Event Reporting and Lareb Coordination
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PSURs and IGJ Inspection Readiness
Netherlands Pharmacovigilance Requirements
| Obligation | Requirement | Authority |
|---|---|---|
| EU QPPV | Reside in EEA; Article 57 database | MEB |
| National contact (if QPPV outside NL or no Dutch) | Medical qualification or access; register before marketing | MEB |
| Serious unexpected SADR | 15 days | EudraVigilance |
| Non-serious ICSRs | 90 days | EudraVigilance |
| PSUR | Per EURD list | EMA Repository |
Pharmacovigilance Company in Netherlands - DDReg Expertise
MEB and IGJ guidance specify the national contact should possess a medical qualification or have direct access to someone with such qualifications. DDReg provides MEB-registered national contact services meeting this requirement, coordinates with medically qualified persons, and maintains the documented back-up procedure required by MEB.
National contact appointment is required if the EU QPPV is resident outside Netherlands OR is not fluent in Dutch. Only Netherlands-resident, Dutch-fluent QPPVs avoid the requirement. DDReg provides national contact services for MAHs not meeting both criteria.
Lareb operates the national spontaneous reporting system on behalf of MEB. The Health and Youth Care Inspectorate (IGJ) conducts PV inspections. DDReg coordinates with both Lareb for spontaneous report follow-up and IGJ for inspection responses.
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