Lesotho

Medicines and pharmacovigilance activities in Lesotho are overseen under the Ministry of Health and the newly established Lesotho Medicines and Medical Devices Regulatory Authority (LeMeRA), pursuant to the medicines and medical devices regulatory framework introduced under the 2023 legislation. The national legal framework assigns the Authority responsibility for monitoring and analysing adverse effects and events associated with medicines and medical devices, assessing causality, taking appropriate regulatory action and reporting relevant safety information to international monitoring systems. It further provides for the issuance of guidelines addressing mandatory safety reporting and periodic safety updates by manufacturers and distributors. However, current publicly accessible national sources do not yet establish detailed universal MAH requirements for a locally resident QPPV, PSMF/PSSF, fixed MAH ICSR reporting timelines, PSUR/PBRER submission periodicity, universal RMP requirements, or detailed MAH signal-management and pharmacovigilance-inspection procedures. These operational requirements should therefore be confirmed with LeMeRA/Ministry of Health as implementing regulations and guidance continue to develop. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.