Regulatory and systemic challenges in verification of medicinal products – the european framework and the bulgarian model

Abstract

Falsified medicinal products represent a global challenge that threatens both patient safety and the sustainability of healthcare systems. The European Union (EU) has responded by introducing a medicines verification system based on unique identifiers, anti-tampering devices, and centralized repositories. This narrative review analyzes the European regulatory framework and places particular emphasis on the Bulgarian model, which represents a unique integration of verification, electronic prescribing, and insurance control. The system, implemented by the Bulgarian Medicines Verification Organization, the National Health Insurance Fund, and the National Health Information System, ensures automated real-time verification of unique identifiers and provides a mechanism for blocking suspicious products. The findings indicate that although the EU maintains a high level of regulatory oversight, the global spread of falsified medicinal products remains a significant problem. The Bulgarian model offers an innovative solution without parallel within the EU, yet its sustainability requires harmonization of sanctions and enhanced international cooperation.