INOPP Forum
Pharmacovigilance Requirements in Italy
Quote from VigiServe Admin on March 15, 2026, 12:16 PMIn Italy, the pharmacovigilance system is fully integrated into the European Union framework and enforced by the Italian Medicines Agency (AIFA). All EU pharmacovigilance legislation applies directly, supported by the National Pharmacovigilance Network (RNF).
1. Clinical Safety (Clinical Trials)
Clinical trials are governed by the EU Clinical Trials Regulation (CTR 536/2014) and require approval via the Clinical Trials Information System (CTIS).
Expedited Reporting: Sponsors report Suspected Unexpected Serious Adverse Reactions (SUSARs) to EudraVigilance.
Fatal or Life-Threatening: Within 7 calendar days.
Other Serious Unexpected: Within 15 calendar days.
Periodic Reporting: Development Safety Update Reports (DSURs) are required annually.
Submission: Electronic submission via CTIS and EudraVigilance.
2. Post-Marketing Pharmacovigilance
Marketing Authorization Holders must maintain a pharmacovigilance system compliant with EU Good Pharmacovigilance Practices.
Personnel & Infrastructure:
Local Qualified Person for Pharmacovigilance: Mandatory. A local representative (Responsabile di Farmacovigilanza) registered with AIFA is required.
Pharmacovigilance System Master File: Mandatory. The file must be maintained and available for AIFA inspections.
Incident Reporting (ICSRs):
Timelines:
Serious: Within 15 calendar days.
Non-Serious: Within 90 calendar days.
Submission: Reports are submitted electronically to EudraVigilance and the RNF.
Risk & Periodic Reporting:
Periodic Benefit-Risk Evaluation Reports: Mandatory. Frequency aligns with the EU EURD list (typically every six months initially, then annually).
Risk Management Plans: Mandatory for new active substances, biologics, and high-risk products.
Additional Monitoring: Medicines under intensive monitoring display the black inverted triangle (▼) in the Summary of Product Characteristics and package leaflet.
Summary of Requirements
Component Requirement in Italy Regulatory Authority AIFA (Italian Medicines Agency) Framework EU Good Pharmacovigilance Practices / RNF Local Qualified Person for Pharmacovigilance Yes (Local Responsible required) Pharmacovigilance System Master File Yes Safety Reporting 15 days (Serious) / 90 days (Non-Serious) Clinical Reporting SUSARs (7/15 days - EU CTR) Submission Language Italian / English
In Italy, the pharmacovigilance system is fully integrated into the European Union framework and enforced by the Italian Medicines Agency (AIFA). All EU pharmacovigilance legislation applies directly, supported by the National Pharmacovigilance Network (RNF).
1. Clinical Safety (Clinical Trials)
Clinical trials are governed by the EU Clinical Trials Regulation (CTR 536/2014) and require approval via the Clinical Trials Information System (CTIS).
-
Expedited Reporting: Sponsors report Suspected Unexpected Serious Adverse Reactions (SUSARs) to EudraVigilance.
-
Fatal or Life-Threatening: Within 7 calendar days.
-
Other Serious Unexpected: Within 15 calendar days.
-
-
Periodic Reporting: Development Safety Update Reports (DSURs) are required annually.
-
Submission: Electronic submission via CTIS and EudraVigilance.
2. Post-Marketing Pharmacovigilance
Marketing Authorization Holders must maintain a pharmacovigilance system compliant with EU Good Pharmacovigilance Practices.
-
Personnel & Infrastructure:
-
Local Qualified Person for Pharmacovigilance: Mandatory. A local representative (Responsabile di Farmacovigilanza) registered with AIFA is required.
-
Pharmacovigilance System Master File: Mandatory. The file must be maintained and available for AIFA inspections.
-
-
Incident Reporting (ICSRs):
-
Timelines:
-
Serious: Within 15 calendar days.
-
Non-Serious: Within 90 calendar days.
-
-
Submission: Reports are submitted electronically to EudraVigilance and the RNF.
-
-
Risk & Periodic Reporting:
-
Periodic Benefit-Risk Evaluation Reports: Mandatory. Frequency aligns with the EU EURD list (typically every six months initially, then annually).
-
Risk Management Plans: Mandatory for new active substances, biologics, and high-risk products.
-
Additional Monitoring: Medicines under intensive monitoring display the black inverted triangle (▼) in the Summary of Product Characteristics and package leaflet.
-
Summary of Requirements
| Component | Requirement in Italy |
| Regulatory Authority | AIFA (Italian Medicines Agency) |
| Framework | EU Good Pharmacovigilance Practices / RNF |
| Local Qualified Person for Pharmacovigilance | Yes (Local Responsible required) |
| Pharmacovigilance System Master File | Yes |
| Safety Reporting | 15 days (Serious) / 90 days (Non-Serious) |
| Clinical Reporting | SUSARs (7/15 days - EU CTR) |
| Submission Language | Italian / English |