Samoa

Pharmacovigilance in Samoa is administered by the Ministry of Health under the Ministry of Health Act 2006 and the Drugs Act 1967, which is administered by the Ministry and its Chief Executive Officer. Under section 18(1) of the Drugs Act, an importer into Samoa or a manufacturer in Samoa that has reason to believe that substantial untoward effects have arisen from use of a drug, whether in Samoa or elsewhere, must notify the Chief Executive Officer forthwith of the nature of those effects and the known circumstances. Section 18(2) provides an exception where those particulars have already been published in English in a medical or pharmaceutical publication ordinarily circulated among the medical and pharmaceutical professions in Samoa. Separately, section 15 requires the importer or Samoa-based manufacturer to notify material changes to indications, dosage, administration, labelling, pharmaceutical form, strength, quality, purity, manufacturing methods or testing facilities, together with any known effect on safe use. The reviewed official sources do not establish a universal MAH-specific GVP framework requiring a resident QPPV, local PSMF, fixed ICSR or PSUR/PBRER schedules, a standardized RMP, or a routine pharmacovigilance-inspection cycle. Product-specific obligations should therefore be confirmed with the Ministry. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.