Belize

Pharmacovigilance in Belize is overseen by the Ministry of Health & Wellness. Belize can also use CARPHA VigiCarib for suspected adverse reactions and medical-product quality reports. A publicly accessible Belize-specific GVP guideline setting out MAH requirements for a local QPPV, PSMF, fixed ICSR timelines, PSUR/PBRER schedules, or RMP submission was not identified in current official sources. Those requirements are not established as mandatory unless confirmed by the Ministry 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.