AEMPS coordinates the Spanish Pharmacovigilance System for Medicinal Products for Human Use within the broader EU pharmacovigilance network.
Core official resources
- AEMPS pharmacovigilance — national pharmacovigilance hub.
- Reporting suspected adverse reactions — AEMPS guidance, updated in March 2026.
- NotificaRAM — national spontaneous-reporting portal.
Practical use
Spain's national pharmacovigilance centres collect and evaluate spontaneous reports while MAH ICSR obligations operate through EudraVigilance. The AEMPS material is useful for local reporting pathways, national safety communications and understanding the Spanish network structure.