Libya

Pharmacovigilance in Libya is overseen through the Ministry of Health and its Pharmacovigilance Centre. The Ministry’s Arabic-language مركز اليقظة الدوائية describes the Centre as responsible for post-authorisation monitoring of medicine and medical-product safety, collection and analysis of adverse-effect information, signal detection and recommendations for regulatory action. Libya has also been rebuilding its national pharmacovigilance infrastructure, including the Ministry’s recent launch of a national pharmacovigilance system described by EMPHNET. However, the current publicly accessible Libyan material reviewed does not clearly publish a comprehensive MAH-specific GVP framework establishing a mandatory Libya-resident QPPV, a PSMF requirement, universal numerical ICSR deadlines, fixed PSUR/PBRER frequencies, a standardized RMP requirement, or a routine pharmacovigilance-inspection cycle. These elements should therefore not be imported from EU or other foreign systems and presented as binding Libyan requirements without confirmation from the competent Libyan authority or a product-specific authorisation condition. MAHs should nevertheless maintain effective post-marketing safety monitoring and be able to communicate safety information to the national authority. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.