Zimbabwe

Pharmacovigilance in Zimbabwe is regulated by the Medicines Control Authority of Zimbabwe (MCAZ). The current Pharmacovigilance Guideline for Pharmaceutical Industry, MCAZ/PVCT/GL-02 Rev. 2, May 2024 applies to MAHs, applicants, manufacturers and local representatives. The MAH must operate a pharmacovigilance system and nominate an appropriately qualified responsible person for products marketed in Zimbabwe, with defined responsibilities and authority notification or approval as applicable. The system must support collection, evaluation and transmission of ICSRs, signal management, documented procedures, staff training and prompt communication of significant benefit-risk information. PSUR/PBRER submission is conditional on the marketing authorisation or an MCAZ request rather than universal; RMPs are required where product risks or authorisation conditions warrant them. MCAZ may inspect the pharmacovigilance system, including alongside GMP activities. The reviewed guideline does not identify a separately named EU-style PSMF, so the MAH should confirm the required system documentation and any product-specific timelines with MCAZ. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance; How to Prepare and Comply with a Pharmacovigilance Inspection.