INOPP Forum
Pharmacovigilance requirements in Monaco
Quote from VigiServe Admin on February 8, 2026, 5:03 AMIn Monaco, Pharmacovigilance is fully integrated into the French regulatory framework. There is no independent national system; the French National Agency for the Safety of Medicines and Health Products (ANSM) acts as the de facto authority. Consequently, Monaco follows EU Good Pharmacovigilance Practices (GVP) without modification.
1. Clinical Safety (Clinical Trials)
Clinical trials are rare but are legally treated as French/EU trials, requiring ANSM authorization.
Approvals: Must be approved by ANSM, typically via the CTIS (Clinical Trials Information System).
Expedited Reporting: Sponsors must report Suspected Unexpected Serious Adverse Reactions (SUSARs) to ANSM according to EU/ICH timelines:
Fatal or Life-Threatening: Within 7 calendar days.
Other Serious Unexpected: Within 15 calendar days.
Periodic Reporting: Development Safety Update Reports (DSURs) are mandatory annually (ICH E2F format).
Submission: All reporting routes through ANSM or EU portals; there is no separate Monaco reporting channel.
2. Post-Marketing Pharmacovigilance
Post-approval obligations are identical to those in France.
Personnel:
QPPV: A Qualified Person for Pharmacovigilance is mandatory (EU-based).
Local Contact: If the QPPV is not resident in France/Monaco, a Local Contact Person is required for liaison with ANSM.
Documentation: A Pharmacovigilance System Master File (PSMF) is mandatory (EU GVP Module II) and must be available for ANSM 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 ANSM is mandatory.
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).
Additional Monitoring: The Black Triangle (▼) scheme applies.
Summary of Requirements
Component Requirement in Monaco Regulatory Authority ANSM (France) Framework French Law / EU GVP Local Personnel QPPV (EU-based) + Local Contact PSMF Required SUSAR Reporting 7 days (fatal) / 15 days (other serious) ICSR Timelines 15 days (serious) / 90 days (non-serious) RMPs Mandatory (EU Style) Special Monitoring Black Triangle (▼) Scheme applies
In Monaco, Pharmacovigilance is fully integrated into the French regulatory framework. There is no independent national system; the French National Agency for the Safety of Medicines and Health Products (ANSM) acts as the de facto authority. Consequently, Monaco follows EU Good Pharmacovigilance Practices (GVP) without modification.
1. Clinical Safety (Clinical Trials)
Clinical trials are rare but are legally treated as French/EU trials, requiring ANSM authorization.
-
Approvals: Must be approved by ANSM, typically via the CTIS (Clinical Trials Information System).
-
Expedited Reporting: Sponsors must report Suspected Unexpected Serious Adverse Reactions (SUSARs) to ANSM according to EU/ICH timelines:
-
Fatal or Life-Threatening: Within 7 calendar days.
-
Other Serious Unexpected: Within 15 calendar days.
-
-
Periodic Reporting: Development Safety Update Reports (DSURs) are mandatory annually (ICH E2F format).
-
Submission: All reporting routes through ANSM or EU portals; there is no separate Monaco reporting channel.
2. Post-Marketing Pharmacovigilance
Post-approval obligations are identical to those in France.
-
Personnel:
-
QPPV: A Qualified Person for Pharmacovigilance is mandatory (EU-based).
-
Local Contact: If the QPPV is not resident in France/Monaco, a Local Contact Person is required for liaison with ANSM.
-
-
Documentation: A Pharmacovigilance System Master File (PSMF) is mandatory (EU GVP Module II) and must be available for ANSM 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 ANSM is mandatory.
-
-
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).
-
Additional Monitoring: The Black Triangle (▼) scheme applies.
-
Summary of Requirements
| Component | Requirement in Monaco |
| Regulatory Authority | ANSM (France) |
| Framework | French Law / EU GVP |
| Local Personnel | QPPV (EU-based) + Local Contact |
| PSMF | Required |
| SUSAR Reporting | 7 days (fatal) / 15 days (other serious) |
| ICSR Timelines | 15 days (serious) / 90 days (non-serious) |
| RMPs | Mandatory (EU Style) |
| Special Monitoring | Black Triangle (▼) Scheme applies |