Pharmacovigilance Requirements Brief Overview

Vanuatu

Pharmacovigilance and medicines oversight in Vanuatu fall under the Ministry of Health, supported by the National Drug and Therapeutics Committee. The Vanuatu National Medicines Policy states that a system should be developed and promoted for reporting and monitoring medicine-quality problems, adverse drug reactions and medication errors. It also provides for the recall or withdrawal of medicines whose quality is considered unacceptable. The Sale of Medicines (Control) Act, CAP. 48 primarily regulates importation, wholesale supply and retail sale and permits inspection of relevant premises for compliance; these are general medicines-control inspections rather than dedicated GVP inspections. Publicly accessible official sources do not establish detailed requirements for a local QPPV or safety contact, PSMF, fixed expedited ICSR timelines, routine PSUR/PBRER submissions, RMPs or formal signal-management procedures. Companies should therefore maintain an appropriate global pharmacovigilance system, ensure prompt escalation of local cases and confirm any product-specific requirements with the Ministry. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.

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