Sudan

Pharmacovigilance in Sudan is regulated by the National Medicines and Poisons Board (NMPB) through its national Pharmacovigilance centre. NMPB confirms that it has approved the Requirements for Good Pharmacovigilance Practices in Sudan for marketing authorisation Holders (MAHs); the official GVP requirements document sets out MAH responsibilities for maintaining a functioning pharmacovigilance system, assigning qualified responsibility, collecting and evaluating safety information, submitting individual and periodic reports, managing risks and supporting inspections. Companies should maintain current system documentation and safety records, ensure suitable local regulatory communication and apply the reporting timelines and PSUR/PBRER schedule specified in the current NMPB requirements and any product-specific conditions. The NMPB website also provides official pharmacovigilance forms. Because access to individual NMPB files can be intermittent and requirements may be revised, MAHs should verify the latest controlled version and electronic or email submission instructions directly with the Pharmacovigilance centre before operational use. Where the cited public sources do not expressly define local QPPV or responsible-person arrangement, pharmacovigilance system file, ICSR reporting route and timelines, risk-management plan and signal management, 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): How to Prepare and Comply with a Pharmacovigilance Inspection.