French ANSM Pharmacovigilance Incident Report Form

Every healthcare professional — doctor (médecin), pharmacist, dental surgeon, midwife (sage-femme), or nurse — is legally obliged to report any suspected adverse reaction linked to a medicinal product, under Article R5121-150 of the CSP. Patients and approved patient associations have had the right to report since Law No. 2011-2012 of 29 December 2011. The marketing authorisation (AMM — autorisation de mise sur le marché) holder for the medicine concerned also carries its own reporting obligation, within the same regulatory deadlines, directly to the ANSM.

Article R5121-151 of the CSP establishes two distinct deadlines: 7 calendar days for serious adverse reactions that are fatal or immediately life-threatening (death or immediate vital risk); 15 calendar days for all other serious adverse reactions, including those resulting in hospitalisation, disability, or congenital malformation. Non-serious reactions carry no statutory deadline but should be reported as soon as practicable. Both deadlines run from the date on which the reporter first became aware of the reaction.

Reports are filed on the national portal signalement.social-sante.gouv.fr, available around the clock, 24/7. This unified platform consolidates all health vigilance systems (pharmacovigilance, materiovigilance — medical device surveillance, nutrivigilance). Creating a professional account is recommended for case tracking and to receive requests for supplementary information. If the portal is temporarily unavailable, a written report may be posted to the territorially competent centre régional de pharmacovigilance (CRPV — regional pharmacovigilance centre).

The form requires: reporter details (name, profession, contact information); pseudonymised patient data (initials, age, sex, weight); a precise description of the adverse reaction (date of onset, clinical course, and outcome — recovery, sequelae, or death); the suspected medicinal product(s) — INN (international non-proprietary name), dosage, route of administration, and exact treatment dates; concomitant medications; and relevant medical history. A unique case reference number is automatically assigned by the portal upon submission.

Yes. The obligation applies without distinction to any medicinal product holding an AMM, whether originator (princeps), generic, or biosimilar. Biosimilars are subject to enhanced pharmacovigilance under Article R5121-150 of the CSP and applicable EMA guidelines on biological medicines. For products under enhanced monitoring — identified by the black inverted triangle (▼) on the package leaflet — all adverse reactions must be reported, even those already listed in the summary of product characteristics (RCP — résumé des caractéristiques du produit), per Article R5121-153 of the CSP.

Failure to report may trigger disciplinary proceedings before the relevant professional regulatory body (Conseil national de l'ordre des médecins or pharmaciens) on grounds of breach of professional ethical obligations. The practitioner's professional civil liability may also be engaged if the omission contributed to harm suffered by a third party. The ANSM holds inspection powers under Article L5313-1 of the CSP and may refer cases of identified non-compliance to the relevant regulatory council.