INFARMED is Portugal's national competent authority for medicines. Portuguese post-authorisation pharmacovigilance operates within the EU pharmacovigilance framework, including EudraVigilance and GVP, with national reporting and safety-communication functions managed through INFARMED.
Core official resources
- INFARMED — national medicines authority.
- EMA Good Pharmacovigilance Practices — EU operational framework applicable in Portugal.
- EudraVigilance — EU ICSR reporting and safety-monitoring system.
Practical use
Use INFARMED for Portugal-specific reporting instructions, national safety communications and local implementation questions; use EMA/EudraVigilance for EU-wide submission and procedural requirements.