The Federal Agency for Medicines and Health Products (FAMHP) is Belgium's national competent authority for medicines and pharmacovigilance.
Core official resources
- FAMHP pharmacovigilance — national pharmacovigilance overview and MAH responsibilities.
- Report a side effect as a healthcare professional — official professional reporting route.
- Report a side effect as a patient — public reporting route.
- Questions and answers on reporting adverse reactions — reporting criteria and explanatory material.
Practical use
FAMHP describes Belgian MAH obligations within the EU pharmacovigilance system, including maintenance of a pharmacovigilance system, responsible-person arrangements, EudraVigilance reporting and periodic safety reporting. Local FAMHP materials remain useful for Belgian reporting routes and national safety communications.