Jamaica

Pharmacovigilance in Jamaica is overseen by the Ministry of Health & Wellness, Standards and Regulation Division (SRD), which operates the National Pharmacovigilance Centre/PharmWatch. The public national Pharmacovigilance page establishes MAH reporting responsibilities but does not establish a universal Jamaica-resident QPPV or EU-style PSMF requirement. Valid serious ICSRs are reported within 15 calendar days and valid non-serious ICSRs within 90 calendar days. PBRER/PSURs are submitted every six months from registration until marketing, every six months for the first two marketed years, annually for the next two years, and every three years thereafter; submissions are due 70 calendar days after the DLP for 6- or 12-month intervals and 90 days for intervals longer than 12 months. Product-specific risk-management requirements apply where issued. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.