The Medicines Verification System in the European Union Celebrates 5 Years of Successful Operation

In Bulgaria over 99% of pharmacies, hospital pharmacies and wholesalers are connected to the System, increasing decommissioning rate is now over 75%

On 9 February 2024 we celebrate the 5th anniversary of the entry into force of the Falsified Medicines Directive in Europe and Bulgaria. “The past 5 years have been full of challenges and successes, related to achieving the main objective of medicines verification – protecting patients by ensuring the authenticity of medicinal products. Together we achieved a high degree of institutional, professional, and public support for the medicines verification process – the largest public-private project in the European Union and in Bulgaria.” This was announced by Illiana Paunova, Executive director of the Bulgarian Medicines Verification Organization (BgMVO).

The medicines verification process started in all EU countries on February 9, 2019, in compliance with the European Falsified Medicines Directive 2011/62/EU and Delegated Regulation (EU) 2016/161. As of 2019, all packs of prescription medicines must be manufactured with an unique identification code and anti-tampering evidence. In the European Hub, manufacturers upload the product codes of all their packages. This guarantees the authentic origin of prescribed medicines throughout the entire supply chain. The role of Master Pharmacists is to confirm the integrity of the pack, verify and decommission its unique code for each dispensed prescription medication to the patient. Whenever an irregularity is detected, the System sends an alert to the pharmacist, the manufacturer and the BgMVO. Duly decommissioning of medicines packaging from the Verification System by Master Pharmacists prevents breaches in the drug supply chain.

One of the most significant achievements of BgMVO in 2023 is the increased activity of pharmacies in working with the Verification System in Bulgaria, said Illiana Paunova. Over 4 million transactions are performed in the System each week. 75% of prescription medicines are being decommissioned in the System, with a 50% increase achieved compared to 2022. This increased activity of pharmacies and the integration of information systems in healthcare ensures transparency of the process and prevents the risks of financial malpractices. The upward trend in the decommissioning rate[IP1]  is expected to continue in 2024, reaching the European target of 90% decommissioning rate, commented Illiana Paunova.

Information from BgMVO shows that 3 251 pharmacies, 202 hospital pharmacies and 190 wholesalers are connected to the Bulgarian Medicines Verification System. 251 pharmaceutical companies supply prescription medicines in Bulgaria and upload data to the Verification System. 33 of these companies are Bulgarian. The total number of medicines on the Bulgarian market, for which data have been uploaded to the System is 5 351. Alerts generated during medicines verification in Bulgaria have decreased below 0.08% and the objective is to maintain this downward trend in 2024.

The Medicines Verification System, Bulgaria’s first nationwide digital system in healthcare, is an example of a successful project for the benefit of Bulgarian patients, around which all participants in the supply chain of medicines are united. It is an integral part of the European Medicines Verification System and operates steadily with high quality requirements in all core and supporting processes. The overall performance and availability of the System in 2023 is above 99%. Looking forward, BgMVO will continue to work in collaboration with the institutions and with all stakeholders in the medicines supply chain to ensure the stable functioning of the Medicines Verification System, to increase the activity of pharmacies, to manage alerts effectively and to contribute to the increasing digitalisation of healthcare.