Eswatini

Pharmacovigilance activities in Eswatini are overseen by the Ministry of Health through the Medicines Regulatory Unit (MRU) and National Pharmacovigilance Centre. Under the Eswatini National Pharmacovigilance Policy and Implementation Framework 2021, manufacturers and importers must establish a pharmacovigilance system headed by a QPPV who should be placed in Eswatini and must maintain a PSMF. Spontaneous reporting by manufacturers, importers and MAHs is mandatory; serious adverse events are reportable within 15 calendar days from Day 0, with expedited reporting overseen by the QPPV. Periodic safety reporting is required biannually during the first two years for new products, annually during the next two years, and every five years thereafter, with PBRERs submitted in accordance with applicable guidance. The national framework also covers signal management, risk management and risk-minimisation activities, PASS, and pharmacovigilance inspections, including routine industry monitoring and for-cause inspections. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): PSMF Maintenance: Concept and Importance in Pharmacovigilance.