Liberia

Pharmacovigilance in Liberia is regulated by the Liberia Medicines and Health Products Regulatory Authority (LMHRA). Under the current national pharmacovigilance framework, MAHs and Local Representatives must maintain an effective pharmacovigilance system and appoint a Qualified Person Responsible for Pharmacovigilance (QPPV) who resides in Liberia, together with appropriate back-up arrangements. A Pharmacovigilance System Master File (PSMF) must be maintained and located in Liberia, either where the main pharmacovigilance activities are performed or where the QPPV operates. Serious adverse reaction reports must be submitted to the LMHRA within 7 calendar days, while non-serious suspected adverse reactions occurring in Liberia must be reported within 28 calendar days. MAHs are also required to conduct regular international and local literature monitoring; significant safety issues and relevant foreign regulatory safety actions must generally be communicated to LMHRA within 7 days. PSUR/PBRER requirements apply to both innovator and generic medicines, including submission at the time of registration renewal, and the framework also addresses RMPs, post-authorisation safety activities, signal and benefit-risk monitoring, pharmacovigilance audits and inspections. The QPPV serves as the principal LMHRA pharmacovigilance contact and must be available during pharmacovigilance inspections. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): How to Prepare and Comply with a Pharmacovigilance Inspection.