Haiti

Pharmacovigilance in Haiti is coordinated by the Direction de la Pharmacie, du Médicament et de la Médecine Traditionnelle (DPM/MT) within the Ministry of Public Health and Population (MSPP). The national pharmacovigilance system involves health professionals, pharmaceutical-sector actors and other stakeholders in detecting and reporting medicine-safety problems. The DPM/MT pharmacovigilance information states that serious or unexpected adverse events should be reported immediately, and safety information may support regulatory action including modification, restriction, suspension or withdrawal of a marketing authorisation. Based on the currently published national requirements, no specific mandatory local QPPV, PSMF, or defined routine PSUR/PBRER and RMP submission schedule could be confirmed for MAHs in Haiti. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.