Successful decommissioning of packs is a legal requirement for reimbursement of medicines by the Health Insurance Fund
The Medicines Verification System in Bulgaria has demonstrated stable operation and reliability for seven years now, with over 99% of pharmacies connected and routinely using it in their daily practice. The steady downward trend in the number of alerts and suspected cases of falsification in the legal supply chain of medicines at national level, show that the system is working and protecting against malpractice. This was announced by Illiana Paunova, executive director of the Bulgarian Medicines Verification Organisation (BgMVO).
The National System is part of the European Medicines Verification System, through which on February 9, 2019, the verification process was launched in implementation of European Falsified Medicines Directive 2011/62/EU and Delegated Regulation (EU) 2016/161. This is the largest public-private project in Europe and Bulgaria, involving all stakeholders in the supply of medicines, created with the objective of providing authentic medicines to patients by preventing the entry and distribution of falsified medicines into the legal supply chain.
By the end of 2025, 271 marketing authorization holders (MAHs) upload data on their medicinal products into the system. The connected end users are 2,978 pharmacies, 207 hospital pharmacies, and 161 wholesalers, according to BgMVO. A total of 6,064 product codes for prescription medicines have been uploaded to the system. On average, over 4 million transactions are performed per week, and over 2.3 million packs are decommissioned weekly, including the entire market of medicines reimbursed by the National Health Insurance Fund. The decommissioning rate in Bulgaria is close to the European average. The alert rate in the system remains below 0.07% of all transactions, and in 2025, most of them were due to technical issues.
The Medicines Verification System in Bulgaria is becoming increasingly important due to the national requirement for successful decommissioning of medicine packs as a condition for reimbursement, which was introduced in 2024. According to the Law on Medicinal Products in Human Medicine, prescription medications for which authenticity has not been verified, and the unique identification code has not been decommissioned in the Verification System, are not reimbursed by the National Health Insurance Fund. This prevents the possible financial abuse of public funds for medicines.
BgMVO was founded by the organisations representing stakeholders in the pharmaceutical supply chain: the Association of Research Pharmaceutical Manufacturers (ARPharM), the Bulgarian Generic Pharmaceutical Association (BGPharma), the Bulgarian Association of Pharmaceutical Wholesalers and Retailers (BAPWR), the Bulgarian Association for Medicines Parallel Trade Development (BAMPTD) and the Bulgarian Pharmaceutical Union (BPU).
BgMVO priorities for 2026 remain ensuring stable and continuous operation of the system, maintaining high quality requirements in daily operations and processes, actively cooperating with all stakeholders and competent authorities in the medicines supply chain.