Guyana

Pharmacovigilance and post-marketing medicines safety in Guyana are overseen by the Government Analyst–Food and Drug Department (GA-FDD) within the Ministry of Health under the national Food and Drugs regulatory framework. GA-FDD provides an official Drug Adverse Reaction reporting form and performs post-marketing regulatory activities, while the pharmaceutical regulatory framework is undergoing modernization. Based on the currently published national requirements, no specific mandatory EU-style QPPV or local pharmacovigilance responsible-person requirement, PSMF requirement, or routine PSUR/PBRER or RMP submission schedule could be confirmed. These requirements are not established national obligations unless specifically requested by the competent authority or imposed as a product-specific condition. 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.