The Medicines Evaluation Board (CBG-MEB) is the Dutch national competent authority for medicines. The Netherlands Pharmacovigilance Centre Lareb manages the national spontaneous-reporting system on its behalf.
Core official resources
- MEB pharmacovigilance for MAHs — national post-authorisation pharmacovigilance requirements.
- Reporting adverse events — ICSR reporting, Lareb cases and Dutch literature-monitoring considerations.
- National contact person for pharmacovigilance — specific Dutch contact-person requirements.
- Lareb — national pharmacovigilance centre and reporting system.
Important national distinction
The MEB states that a national contact person should be appointed if the EU QPPV is resident outside the Netherlands or is not fluent in Dutch. The contact person must be registered with the MEB and acts as a national authority, patient and healthcare-professional contact.
The MEB also provides explicit examples of Dutch local medical publications relevant to literature-surveillance strategy. These national elements should be managed alongside EU GVP and EudraVigilance obligations.