Kuwait

Pharmacovigilance activities in Kuwait are overseen by the Ministry of Health's Drug and Food Control sector under the Kuwaiti Good Pharmacovigilance Practice (KuGVP) Guidelines. The MAH must establish a pharmacovigilance system, designate a qualified person responsible for pharmacovigilance and appropriate local safety/back-up arrangements, maintain a PSMF, collect and submit adverse-reaction reports and comply with applicable periodic-reporting and risk-management requirements. The MOH KuGVP modules, rather than the Public Authority for Food and Nutrition, are the relevant official source for human-medicines pharmacovigilance requirements. Where the cited public sources do not expressly define periodic safety reporting, risk-management plan, 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): PSMF Maintenance: Concept and Importance in Pharmacovigilance.