An average of 4.5 million transactions are being performed weekly in the country, with activity levels nearing 83%
Falsified medicines are a growing threat worldwide. To prevent the entry and distribution of falsified medicines into the legal supply chain in Europe, the medicines verification process was launched on 9 February 2019 in implementation of the European Falsified Medicines Directive 2011/62/EU and Delegated Regulation (EU) 2016/161. This is the largest public-private project in Europe and Bulgaria, launched in the benefit of patients’ safety.
For six years now, the Bulgarian Medicines Verification System, the first national digital system in medicines supply, has been working steadily as part of the European Medicines Verification System. The main purpose of verification is to guarantee the authentic origin of medicines throughout the entire supply chain.
Pharmacies, hospital pharmacies and wholesalers are connected to the Bulgarian system, enabling them to verify and decommission the unique identifier of each dispensed prescription medication pack. Duly decommissioning of medicines packs from the Verification System by Master Pharmacists prevents breaches in the drug supply chain.
“During the past year, we have achieved full capacity utilization of the System, which has proven its robust operation and reliability despite the increased volume of transactions. The National Health Insurance Fund (NHIF) has introduced regular use of the Bulgarian Medicines Verification System as part of the effective control process regarding the expenditure of public resources for reimbursed medicines,” said Illiana Paunova, Executive Director of BgMVO.
In Bulgaria, as of December 2024, 260 marketing authorization holders upload their medicines data into the Medicines Verification System. The number of uploaded product codes is 6804. A total of 2950 pharmacies, 204 hospital pharmacies and 161 wholesalers are connected to the System. An average of 4.5 million transactions are performed each week.
In 2024 an average of 82.3% of prescription medicines in Bulgaria are being decommissioned in the Verification System compared to 56% in 2023, Illiana Paunova said. This is the “activity” indicator, which in the last quarter of 2024 exceeded 85%. The key driver for improved activity is the requirement for a successfully decommissioned pack in the Verification System for the purposes of reimbursement process. According to the changes in the Law on Medicinal Products in Human Medicine, prescription medicines that have not been verified for authenticity and the unique identifier has not been decommissioned in the Verification System shall not be paid by the NHIF.
BgMVO’s priorities in 2025 are to maintain the robust operation of the System, support and assist users, and achieve pharmacy activity above 90%. A key principle in the successful work of BgMVO team is cooperation and continuous communication with the institutions and with all participants in the medicines supply chain – manufacturers, pharmacies, hospital pharmacies, wholesalers, as well as the active support of the BgMVO‘s founding organizations. The founding organizations of BgМVO, which are also members of the Board, are: 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).