Tuvalu

Medicines oversight and pharmacovigilance in Tuvalu are administered by the Ministry of Health with support from the National Drugs and Therapeutics Committee. The official Pharmacy and Therapeutic Products Act 2016 regulates the sourcing, importation, supply and use of therapeutic products and assigns the national committee functions that include receiving, collating and reviewing adverse drug reaction reports. Safety concerns should therefore be reported through the Ministry, pharmacy service and national committee using the channels made available locally. The public legal framework reviewed for this guide does not specify a company QPPV or local safety-contact role, a PSMF, fixed expedited ICSR deadlines, routine PSUR/PBRER submissions, mandatory RMPs, formal signal-management procedures or a standalone GVP-inspection programme. Companies supplying medicines should retain complete safety records, apply their global pharmacovigilance procedures and confirm any product-specific requirements with the Ministry. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.