Pharmacovigilance Requirements Brief Overview

Mauritius

Pharmacovigilance in Mauritius is coordinated by the Ministry of Health and Wellness through its national pharmacovigilance structures. The Ministry’s official Departments page confirms the National Pharmacovigilance Committee and the national system for managing medicine-safety and quality issues; Mauritius has also expanded reporting access through the government’s 2025 VigiMobile launch, enabling suspected adverse effects of medicines and vaccines to be reported more readily. These sources demonstrate an active national post-market safety function and an expectation that medicine suppliers cooperate with adverse-event monitoring and regulatory safety actions. However, the currently accessible official public material reviewed does not clearly publish a single MAH-specific GVP framework establishing a Mauritius-resident QPPV, PSMF, universal numerical marketed-product ICSR timelines, fixed PSUR/PBRER frequencies, a standardized RMP requirement, or a routine pharmacovigilance-inspection interval. Such details should therefore be confirmed from the applicable registration conditions or directly with the competent Mauritian authority. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.

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