Quote from VigiServe Admin on February 10, 2026, 1:13 PM

In San Marino, there is no independent pharmacovigilance system. The country is fully integrated into the Italian regulatory framework. All pharmacovigilance activities are outsourced to the Italian Medicines Agency (AIFA) and follow EU GVP standards strictly.

1. Clinical Safety (Clinical Trials)

Clinical trials are virtually non-existent due to the small population, but if they occurred, they would fall under the EU Clinical Trials Regulation (CTR 536/2014) via the CTIS portal.

• Expedited Reporting: Sponsors must report SUSARs to EudraVigilance/AIFA.

  • Fatal or Life-Threatening: Within 7 calendar days.

  • Other Serious Unexpected: Within 15 calendar days.

• Submission: Centralized via the EU CTIS portal or directly to AIFA.

2. Post-Marketing Pharmacovigilance

San Marino treats Marketing Authorization Holders (MAHs) exactly as Italy does.

• Personnel & Infrastructure:

  • QPPV: Mandatory. An EU QPPV is required (usually resident in the EEA). A local contact person in Italy/San Marino is often required for liaison.

  • PSMF: Mandatory and must be accessible for AIFA inspections.

• Incident Reporting (ICSRs):

  • Enforcement: Strict (EU standards).

  • Timelines:

    • Serious: Within 15 calendar days.

    • Non-Serious: Within 90 calendar days.

• Risk & Periodic Reporting:

  • PSURs: Mandatory; submitted to the AIFA repository (frequency follows EU EURD list: 6m/1y/3y).

  • RMPs: Mandatory (EU format).

Summary of Requirements

Component	Requirement in San Marino
Regulatory Authority	AIFA (Italy)
Framework	EU GVP / Italian Law
Local QPPV / PSMF	Yes (EU QPPV) / Yes
Safety Reporting	15 days (Serious) / 90 days (Non-Serious)
Clinical Reporting	SUSARs (7/15 days - EU CTR)
Submission Language	Italian