Grenada

Pharmacovigilance and post-marketing medicines safety activities in Grenada fall under the national medicines regulatory framework administered through the Ministry of Health, with the Chief Pharmacist acting as Registrar under the Medical Products (Regulations) Act, Cap. 189. The Act requires medicinal products to meet standards of quality, safety and efficacy and provides regulatory powers relating to product licensing, continued compliance, inspection, withdrawal and recall. Grenada also participates in regional medicines-safety activities supported by the Caribbean Public Health Agency (CARPHA) through VigiCarib, which facilitates reporting of suspected adverse drug reactions (ADRs) and other medicine-related safety or quality issues. Based on publicly available national requirements, no specific Grenada requirement for appointment of a local QPPV, maintenance of a country-specific PSMF, or routine submission of PSURs/PBRERs or RMPs could be confirmed. Companies should therefore comply with applicable national licensing and safety requirements and any product-specific requests from the Grenadian competent authority. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.