Dominica

Pharmacovigilance and medicines-safety oversight in Dominica are under the Ministry of Health, Wellness and Social Services within the national medicines framework. Regional post-marketing safety reporting is supported through CARPHA VigiCarib, a regional mechanism for monitoring adverse reactions and substandard or falsified medical products. The Dominica Pharmacy Act, 2024 forms part of the national medicines framework, but current publicly accessible national sources do not establish detailed universal MAH requirements for a local QPPV, PSMF/PSSF, fixed MAH ICSR timelines, routine PSUR/PBRER periodicity, universal RMP submission, or a dedicated GVP inspection framework. Product-specific post-marketing safety obligations should therefore be confirmed with the Ministry of Health. Where the cited public sources do not expressly define signal management, the MAH should confirm the current product-specific requirements with the competent authority and against the marketing-authorisation conditions. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.