Oman

Pharmacovigilance in Oman is regulated by the Ministry of Health's Drug Safety Center under the Guideline on Good Pharmacovigilance Practices in Oman. The MAH must establish a quality-managed pharmacovigilance system, appoint an approved QPPV meeting the guideline's residence and availability conditions with back-up arrangements, maintain the required PSMF/local documentation, report ICSRs within national timelines, and fulfil applicable PSUR/PBRER, RMP, signal-management, audit and inspection obligations. Implementation should be checked against the current guideline version, reporting portal, marketing-authorisation conditions and later authority directions, because product-specific requirements can alter the operational details. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): PSMF Maintenance: Concept and Importance in Pharmacovigilance.