Zambia

Pharmacovigilance in Zambia is regulated by the Zambia Medicines Regulatory Authority (ZAMRA) under the Medicines and Allied Substances Act and the Medicines and Allied Substances (Marketing Authorisation of Medicines) Regulations, 2019. A foreign applicant must appoint a local responsible person resident in Zambia; after authorisation, that person implements the pharmacovigilance plan for the foreign MAH. The regulations do not describe the role as a separate QPPV or prescribe specific medical or pharmaceutical qualifications. The reviewed provisions do not expressly establish a separate EU-style PSMF, universal PSUR/PBRER or RMP schedule, fixed MAH ICSR deadlines, a formal signal programme or a dedicated routine GVP-inspection interval. Those details should be confirmed with ZAMRA and against the applicable marketing-authorisation conditions. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.