INOPP Forum
Pharmacovigilance Requirements in France
Quote from VigiServe Admin on March 15, 2026, 12:14 PMIn France, the pharmacovigilance system is fully integrated into the European Union framework and enforced by the Agence nationale de sécurité du médicament et des produits de santé (ANSM). While EU legislation applies directly, France imposes strict national requirements, notably the mandate for a local responsible person.
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 must 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 and the French Public Health Code (Code de la santé publique).
Personnel & Infrastructure:
Local Responsible Person: Mandatory. In addition to the EU Qualified Person for Pharmacovigilance, companies must appoint a local Responsable de Pharmacovigilance (RPV). The RPV must reside and work in France and be a qualified medical doctor or pharmacist.
Pharmacovigilance System Master File: Mandatory. The file must be maintained within the EU and available for ANSM inspections.
Incident Reporting (Individual Case Safety Reports):
Timelines:
Serious: Within 15 calendar days.
Non-Serious: Within 90 calendar days.
Submission: All reports are submitted electronically to EudraVigilance. ANSM accesses these directly.
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. A national French annex may be required to outline specific local risk minimization measures.
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 France Regulatory Authority ANSM (Agence nationale de sécurité du médicament) Framework EU Good Pharmacovigilance Practices / Public Health Code Local Qualified Person for Pharmacovigilance Yes (Local RPV 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 French / English
In France, the pharmacovigilance system is fully integrated into the European Union framework and enforced by the Agence nationale de sécurité du médicament et des produits de santé (ANSM). While EU legislation applies directly, France imposes strict national requirements, notably the mandate for a local responsible person.
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 must 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 and the French Public Health Code (Code de la santé publique).
-
Personnel & Infrastructure:
-
Local Responsible Person: Mandatory. In addition to the EU Qualified Person for Pharmacovigilance, companies must appoint a local Responsable de Pharmacovigilance (RPV). The RPV must reside and work in France and be a qualified medical doctor or pharmacist.
-
Pharmacovigilance System Master File: Mandatory. The file must be maintained within the EU and available for ANSM inspections.
-
-
Incident Reporting (Individual Case Safety Reports):
-
Timelines:
-
Serious: Within 15 calendar days.
-
Non-Serious: Within 90 calendar days.
-
-
Submission: All reports are submitted electronically to EudraVigilance. ANSM accesses these directly.
-
-
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. A national French annex may be required to outline specific local risk minimization measures.
-
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 France |
| Regulatory Authority | ANSM (Agence nationale de sécurité du médicament) |
| Framework | EU Good Pharmacovigilance Practices / Public Health Code |
| Local Qualified Person for Pharmacovigilance | Yes (Local RPV 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 | French / English |