South Africa

Pharmacovigilance in South Africa is regulated by the South African Health Products Regulatory Authority (SAHPRA). Under SAHPRA’s official Pharmacovigilance systems guideline, every applicant or Holder of a Certificate of Registration (HCR) must operate a quality-assured pharmacovigilance system, permanently appoint a qualified person responsible for pharmacovigilance (QPPV), and maintain a company-specific Pharmacovigilance System Master File (PSMF) covering products marketed in South Africa. A South African QPPV is expected to reside and operate locally; where a multinational organisation’s global QPPV is located elsewhere, a local Pharmacovigilance Officer is required. QPPV appointments and changes should be notified to SAHPRA within 30 calendar days, and a requested PSMF should generally be supplied within 14 calendar days. PSUR/PBRER and RMP obligations follow SAHPRA requirements and product conditions. SAHPRA also publishes a dedicated pharmacovigilance-inspections guideline and maintains a consolidated vigilance-guidelines page for current versions. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): PSMF Maintenance: Concept and Importance in Pharmacovigilance.