Antigua and Barbuda

Medicines and pharmacy oversight in Antigua and Barbuda is undertaken by the Ministry of Health, Wellness and the Environment through its Pharmaceutical Division, alongside the Pharmacy Council under the Pharmacy Act and Pharmacy Regulations. Antigua and Barbuda also participates in the regional CARPHA VigiCarib network for reporting suspected adverse reactions and medical-product quality problems. The current public official sources do not establish country-specific MAH requirements for a local QPPV, PSMF, PSUR/PBRER, RMP, or fixed ICSR timelines. These requirements are not established as mandatory unless confirmed by the Ministry/competent 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.