Barbados

Pharmacovigilance and medicines-safety activities in Barbados are coordinated by the Ministry of Health and Wellness through the Barbados Drug Service and pharmaceutical services. The Ministry's health reporting documents confirm ongoing national pharmacovigilance/ADR monitoring, and Barbados also participates in CARPHA VigiCarib for regional reporting and follow-up. A standalone public national GVP guideline establishing MAH-specific requirements for a local QPPV, PSMF, fixed ICSR timelines, PSUR/PBRER schedules, or RMP submission was not identified in current official sources. These requirements are therefore not established as mandatory without confirmation from the competent Barbadian authority for the relevant product. Where the cited public sources do not expressly define signal management and audit and inspection arrangements, 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.