In Bulgaria over 99% of pharmacies, hospital pharmacies and wholesalers are connected to the System, and it is being used more actively
Over 3,380 pharmacies, hospital pharmacies and wholesalers, or over 99% of all participants in the pharmaceutical supply chain, are connected to the Bulgarian Medicines Verification System (BgMVS), in the third year since the Delegated Regulation against counterfeit medicines entry, which is mandatory in all EU member states. “Achieving high connectivity of pharmacies is one of the most significant successes of Bulgarian Medicines Verification Organization (BgMVO) so far: at the beginning of 2021 over 18% of pharmacies were not connected. As a result of our activities, almost all operating pharmacies and wholesalers are connected to the System”, announced Illiana Paunova, Executive director of BgMVO, on the anniversary of the integrated medicines verification system in the EU.
After February 9th, 2019, all prescription medicines are manufactured with a unique identification code and contain an anti-tampering evidence. This is an obligation of the EU countries under European Directive 2011/62/EU and Delegated Regulation 2016/161, aiming to guarantee the origin and quality of prescribed medicines throughout the pharmaceutical supply chain. The national systems are connected in the integrated European medicines verification system. The codes of all manufactured packages are registered by the producers in the European Hub, and from there are distributed into the national systems. All Bulgarian manufacturers serialise and upload their products’ data in the European hub.
The role of pharmacies is to check and deactivate the package code when dispensing the medicine to the patient. “Together with our partners from the Bulgarian Pharmaceutical Union, we regularly inform the pharmaceutical society about the project development and the importance of medicines verification as part of the professional standard for good pharmaceutical practice. Our active partnership continues this year through training seminars and other joint initiatives”, said Illiana Paunova.
In 2022, a key priority for BgMVO is to increase end-users (pharmacies, hospital pharmacies and wholesalers) activity for verification and decommissioning in the System at each dispensing of a prescription package. This will fully achieve the fundamental purpose of verification - protection of patients and consumers by guaranteeing the authenticity of medicinal products. The aim is for end-user activity to reach the European average of 65%.
End-users’ activity is an indicator measured by the number of decommissioned packs in relation to the total market size. Despite the large number of transactions, over 2,5 million verifications per week and the achieved improvement of 20%, this indicator for Bulgaria remains relatively low. Only 35-40% of the packs are decommissioned, while some countries in Europe have achieved 100% activity in pharmacies.
In 2020 the changes in Bulgarian legislation, related to the verification of medicines were adopted and are already in force. They set out the obligations regarding medicines verification of all stakeholders in the pharmaceutical supply chain, as well as the penalties for non-compliance. According to the Law of Medicinal Products in Human Medicine, the Control body for implementation of Regulatory requirements is the Bulgarian Drug Agency, and the role of BgMVO to introduce and manage the National medicines verification system is also established.
The work of BgMVO received high assessment after the audit conducted by the European Medicines Verification Organization in October 2021. The audit scope included development, operation and security of the National Medicines Verification System, evaluation of the IT Supplier as well as the BgMVO Quality Management System. The conclusion of the audit stated that the Bulgarian Medicines Verification System meets the highest European requirements for quality and security.
The cooperation and regular communication with Bulgarian institutions, with all stakeholders of the medicines supply chain: manufacturers, pharmacies, hospital pharmacies, wholesalers, as well as the active support of the founding member organizations of the Association, are fundamental principles in the successful work of BgMVO team.
Photo: The BgMVO team: Nikolay Enchev, Illiana Paunova, Nina Nikolova and Gergana Keremedchieva