Serbia

Pharmacovigilance in Serbia is regulated by the Medicines and Medical Devices Agency of Serbia (ALIMS). The official Rulebook on reporting and monitoring adverse reactions requires each marketing authorisation Holder (MAH) to maintain a pharmacovigilance system and a Detailed Description of the Pharmacovigilance System (DDPS) available for inspection. The MAH must employ, on a full-time and indefinite basis, a qualified pharmacovigilance-responsible person who resides in Serbia and is available to ALIMS 24/7; a resident deputy may also be appointed. Serious domestic suspected adverse reactions and serious unexpected foreign reactions must generally be submitted within 15 calendar days. The Rulebook also covers Risk Management Plans (RMPs), post-authorisation safety studies and periodic reporting. Unless ALIMS sets another schedule, PSURs are submitted every six months for the first two years after market placement, annually for the next two years, and every three years thereafter. Healthcare professionals and patients can use ALIMS’s Serbian-language adverse-reaction reporting page. MAHs should confirm product-specific schedules and any updated electronic-submission instructions directly with ALIMS. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): How to Prepare and Comply with a Pharmacovigilance Inspection.