Montenegro

Pharmacovigilance in Montenegro is regulated by the Institute for Medicines and Medical Devices (CInMED). The new Montenegrin Zakon o ljekovima (2026) establishes a detailed human-medicines pharmacovigilance system. A marketing-authorisation applicant/holder must have a person responsible for pharmacovigilance who is appropriately educated and trained, available 24 hours and resident in Montenegro; the MAH must also maintain and make available a PSMF, operate a risk-management system for each medicine, and regularly audit its pharmacovigilance system. The 2026 law sets electronic ICSR timelines of 15 days for serious suspected adverse reactions and 90 days for non-serious suspected adverse reactions, with specified treatment of EU and third-country cases, and it requires cooperation with CInMED and EMA under the applicable pathway. PSUR and RMP concepts are expressly embedded in the law, with product-specific and implementing requirements applying as appropriate. CInMED’s uputstva za nosioca dozvole za lijek provides the national MAH-facing pharmacovigilance instructions. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): PSMF Maintenance: Concept and Importance in Pharmacovigilance; How to Prepare and Comply with a Pharmacovigilance Inspection.