Fiji

Pharmacovigilance activities in Fiji are overseen by the Fiji Medicines Regulatory Authority (Fiji MRA) within the Ministry of Health and Medical Services. Fiji MRA collects, assesses, investigates and monitors adverse drug reactions and may issue safety alerts or recalls. The National Medicinal Products Policy 2013 assigns manufacturers, importers, distributors, prescribers and pharmacists a duty to notify safety concerns, while national law requires relevant licence holders to maintain adverse-effect records and provide information where required. Current publicly accessible national sources do not establish a universal local QPPV or residency requirement, PSMF, fixed MAH ICSR timeline, routine PSUR/PBRER schedule, universal RMP requirement, or a detailed MAH signal-management framework. General pharmaceutical inspection powers do not, by themselves, establish a specific GVP inspection regime. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.