Botswana

Pharmacovigilance in Botswana is overseen by the Botswana Medicines Regulatory Authority (BoMRA). The current Medicines and Related Substances Act, 2025 establishes the national vigilance programme and an annual pharmacovigilance levy for marketing authorisation holders. BoMRA also publishes national ADR-reporting guidance, including the National Pharmacovigilance Guidelines for ADR Reporting by HCPs. The current public BoMRA sources do not establish a general MAH requirement for an EU-style local QPPV or PSMF, nor a universal PSUR/RMP submission schedule; those requirements are not established without a current product-specific or BoMRA provision. MAHs should comply with the Act, applicable registration conditions and BoMRA safety-reporting instructions. Where the cited public sources do not expressly define ICSR reporting route and timelines, signal management and audit and inspection arrangements, the MAH should confirm the current product-specific requirements with the competent authority and against the marketing-authorisation conditions. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.