Bosnia and Herzegovina

Pharmacovigilance in Bosnia and Herzegovina is regulated by the Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina (ALMBIH) under the new Rulebook on reporting, collecting and monitoring adverse reactions to medicines (Official Gazette BiH 27/26) published in April 2026. The MAH must appoint a pharmacovigilance responsible person who resides in Bosnia and Herzegovina and has a pharmacy, medical or dental degree; the person must be available to the Agency as a 24-hour contact and for pharmacovigilance inspection. The responsible person must send each unexpected adverse reaction or suspicion received from Bosnia and Herzegovina no later than the first working day after Day 0, and urgent safety measures must be notified no later than 24 hours after receipt. MAHs must maintain and submit for Agency assessment a local detailed description of the pharmacovigilance system for authorised medicines, maintain risk-management plans in line with GVP, and prepare/submit PSURs according to the Rulebook and applicable EURD or national schedules. This 2026 Rulebook should be used instead of a generic EU-template description. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): How to Prepare and Comply with a Pharmacovigilance Inspection.