Djibouti

Pharmacovigilance and medicines regulation in Djibouti are overseen by the Ministry of Health through the Direction des Médicaments, de la Pharmacie et des Laboratoires (DMPL). National legislation assigns the medicines regulatory structure responsibility for implementing pharmacovigilance measures. However, current publicly accessible national sources do not establish detailed universal MAH requirements for a local QPPV or residency, PSMF/PSSF, fixed ICSR reporting timelines, PSUR/PBRER periodicity, Risk Management Plans (RMPs), signal-management timelines, or specific pharmacovigilance inspection and electronic-reporting obligations. Marketing authorisation Holders and applicants should therefore confirm the applicable post-marketing safety and adverse-reaction reporting requirements directly with the Ministry of Health/DMPL for the relevant product and regulatory route. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.