Sierra Leone

Pharmacovigilance in Sierra Leone is regulated by the Pharmacy Board of Sierra Leone (PBSL) through its Pharmacovigilance and Clinical Trials Department. The Board’s official Safety Monitoring of Medicinal Products guideline requires marketing authorisation Holders (MAHs) and local representatives to operate a system for collecting, validating, assessing and reporting safety information. Serious local suspected adverse reactions must be reported within 7 calendar days, while non-serious local reports must be submitted within 28 calendar days. The guidance also expects systematic follow-up, weekly screening of widely referenced safety databases, local literature monitoring, relevant digital-media monitoring and submission of follow-up safety information within 7 days when available. Companies should retain documented procedures, trained personnel and records that allow regulatory review, and should manage signals and risk-minimisation actions in coordination with PBSL. The Board maintains an official guidelines repository and an online adverse-drug-reaction reporting page. Product-specific PSUR/PBRER, RMP and inspection obligations should be checked against the current authorisation and any PBSL directions. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): How to Prepare and Comply with a Pharmacovigilance Inspection; Effective Signal Management in Pharmacovigilance.