Namibia

Pharmacovigilance in Namibia is regulated by the Namibia Medicines Regulatory Council (NMRC), with national safety activities coordinated through the Therapeutics Information and Pharmacovigilance Centre (TIPC). Under the official National Guidelines for Medicines Safety Surveillance, every Holder of a Certificate of Registration (HCR/MAH) must maintain an appropriate pharmacovigilance system capable of collecting, preparing and submitting expedited adverse-reaction reports and periodic safety information. An adverse event occurring in Namibia should be reported to NMRC within 15 days of awareness, while a serious event must be reported within 5 working days; significant foreign regulatory safety actions must be communicated within 3 days, and withdrawal of a product’s registration in another country within 24 hours of first knowledge. The Guidelines also require PSURs every six months for the first two years of marketing, annually for the following three years, and every three years thereafter, unless NMRC specifies otherwise. Risk Management Plans are required in defined circumstances, including new active substances, similar biological products, certain products presenting safety concerns, significant authorisation changes, or when requested by NMRC. Importantly, the current Namibia CTD requirements require a CV of the person responsible for pharmacovigilance, but do not expressly establish an EU-style QPPV residency requirement or a separate PSMF requirement. Suspected adverse events may be submitted through the current TIPC pharmacovigilance reporting system. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.