AIFA coordinates pharmacovigilance for medicines in Italy within the EU regulatory network and through Italy's National Pharmacovigilance Network.
Core official resources
- Adverse reactions to medicinal products — AIFA's official reporting guidance and online reporting route.
- Persons in charge of pharmacovigilance — current regional and local pharmacovigilance contacts within the Italian system.
- AIFA pharmacovigilance — national safety-monitoring information and related regulatory material.
Practical use
Italian spontaneous reports feed the national pharmacovigilance network and the wider EudraVigilance system. MAHs should distinguish their EU reporting obligations from the national network's role in local case collection, evaluation and safety monitoring.