INOPP Forum
Pharmacovigilance Requirements in Vatican City
Quote from VigiServe Admin on February 8, 2026, 11:24 AMIn Vatican City, the pharmacovigilance system is non-existent as an independent entity. The State has no national PV centre and delegates all regulatory authority to Italy. Consequently, the Italian Medicines Agency (AIFA) acts as the competent authority, and all EU Good Pharmacovigilance Practices (GVP) apply directly.
1. Clinical Safety (Clinical Trials)
Clinical trials are virtually non-existent due to the population size (~800) and lack of research infrastructure. If they were to occur, they would fall under EU Regulation 536/2014.
Expedited Reporting: Sponsors must report SUSARs to AIFA/EMA via EudraVigilance:
Fatal or Life-Threatening: Within 7 calendar days.
Other Serious Unexpected: Within 15 calendar days.
Submission: All reporting routes through AIFA or the EU Clinical Trials Information System (CTIS).
2. Post-Marketing Pharmacovigilance
Post-approval obligations are identical to those in Italy.
Personnel:
QPPV: The EU QPPV covers Vatican City.
Local Contact: No separate Vatican contact is required; the Italian contact suffices.
Documentation: A Pharmacovigilance System Master File (PSMF) is mandatory (EU GVP Module II) and must be available for AIFA inspections.
Incident Reporting (ICSRs):
Serious Cases: Report within 15 calendar days.
Non-Serious Cases: Report within 90 calendar days.
Submission: Electronic reporting via E2B(R3) to the EudraVigilance database.
Risk & Periodic Reporting:
PSURs: Submitted in ICH E2C(R2) format. Typically every 6 months (first 2 years), then annually.
RMPs: Mandatory for new active substances and high-risk products (EU GVP Module V).
Summary of Requirements
Component Requirement in Vatican City Regulatory Authority AIFA (Italy) Framework Italian Law / EU GVP Local Personnel QPPV (EU-based) PSMF Required SUSAR Reporting 7 days (fatal) / 15 days (other serious) ICSR Timelines 15 days (serious) / 90 days (non-serious) RMPs Mandatory (EU Style) Submission Language Italian
In Vatican City, the pharmacovigilance system is non-existent as an independent entity. The State has no national PV centre and delegates all regulatory authority to Italy. Consequently, the Italian Medicines Agency (AIFA) acts as the competent authority, and all EU Good Pharmacovigilance Practices (GVP) apply directly.
1. Clinical Safety (Clinical Trials)
Clinical trials are virtually non-existent due to the population size (~800) and lack of research infrastructure. If they were to occur, they would fall under EU Regulation 536/2014.
-
Expedited Reporting: Sponsors must report SUSARs to AIFA/EMA via EudraVigilance:
-
Fatal or Life-Threatening: Within 7 calendar days.
-
Other Serious Unexpected: Within 15 calendar days.
-
-
Submission: All reporting routes through AIFA or the EU Clinical Trials Information System (CTIS).
2. Post-Marketing Pharmacovigilance
Post-approval obligations are identical to those in Italy.
-
Personnel:
-
QPPV: The EU QPPV covers Vatican City.
-
Local Contact: No separate Vatican contact is required; the Italian contact suffices.
-
-
Documentation: A Pharmacovigilance System Master File (PSMF) is mandatory (EU GVP Module II) and must be available for AIFA inspections.
-
Incident Reporting (ICSRs):
-
Serious Cases: Report within 15 calendar days.
-
Non-Serious Cases: Report within 90 calendar days.
-
Submission: Electronic reporting via E2B(R3) to the EudraVigilance database.
-
-
Risk & Periodic Reporting:
-
PSURs: Submitted in ICH E2C(R2) format. Typically every 6 months (first 2 years), then annually.
-
RMPs: Mandatory for new active substances and high-risk products (EU GVP Module V).
-
Summary of Requirements
| Component | Requirement in Vatican City |
| Regulatory Authority | AIFA (Italy) |
| Framework | Italian Law / EU GVP |
| Local Personnel | QPPV (EU-based) |
| PSMF | Required |
| SUSAR Reporting | 7 days (fatal) / 15 days (other serious) |
| ICSR Timelines | 15 days (serious) / 90 days (non-serious) |
| RMPs | Mandatory (EU Style) |
| Submission Language | Italian |