Albania

Pharmacovigilance in Albania is regulated by the National Agency for Medicines and Medical Devices (AKBPM) under Law No. 105/2014 on Medicines and Pharmaceutical Service and the Albanian Pharmacovigilance Regulation approved in January 2025. The MAH must operate a pharmacovigilance system, have permanently and continuously available a qualified person for pharmacovigilance who is resident in Albania, maintain and make available on request the required pharmacovigilance-system reference documentation, report suspected adverse reactions, submit periodic safety updates and operate the required risk-management system, including monitoring risk-minimisation measures and emerging safety information. National inspection and enforcement provisions apply. Where the cited public sources do not expressly define pharmacovigilance system file, 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.