Four years since the successful launch of Medicines Verification System in the European Union

In Bulgaria over 99% of pharmacies, hospital pharmacies and wholesalers are connected to the Medicines Verification System, which protects patients by keeping the legal drug supply chain safe from falsified medicines.

On the fourth year since the start of medicines verification process in the EU member states, the Medicines Verification System in Bulgaria has been proven reliable, works sustainably and has a connectivity level of more than 99% from a total of over 3500 End[1]Users – pharmacies, hospital pharmacies and wholesalers. Such is the level of connectivity in most European countries. This was announced by Illiana Paunova, executive director of Bulgarian Medicines Verification Organization (BgMVO).

The medicines verification process officially 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 prescription medicines must be manufactured with a unique identification code and anti-tampering evidence on the secondary pack. This guarantees the origin and quality of the prescribed medicines throughout the drug supply chain. For this purpose, it is necessary to scan each dispensed pack at the pharmacy – this action deactivates the identification code. In case an irregularity is being detected, the System sends an alert to the European Hub, where the codes of all manufactured packages are registered.

The role of the pharmacies is to check and deactivate (decommission) the package code each time a prescription pack is dispensed to the patient. Thus, the fundamental purpose of verification – protection of patients by guaranteeing the authenticity of medicinal products, will be fully achieved.

The activity of pharmacies is an indicator measured by the number of decommissioned packs in relation to the total volume of dispensed prescription medicines. Despite the large number of transactions – over 2,5 million verifications per week, this indicator for Bulgaria remains low, noted Illiana Paunova. Only 45% of the prescription packs in Bulgaria are decommissioned, while some countries in Europe have achieved 100% activity in pharmacies. This is the key priority for the work of Medicines Verification System in 2023 – to increase the decommissioning rate of pharmacies to the European average of 67%.

To improve the overall activity in the usage of the Medicines Verification System, continuous monitoring, and prescriptions for corrective actions by the Bulgarian Drug Agency, the Competent Authority, are needed.

In 2022 BgMVO focus was to increase the activity of pharmacies and to implement an alert management system for monitoring alerts received during the verification process. Cooperation and regular communication with the institutions were very important regarding the undertaken legislative changes, related to Verification System use in Bulgaria. Quality management activities in the organization continued and an information cyber security audit was successfully completed.

In 2022, with the cooperation of BgMVO, Ministry of Health and BDA, amendments, and additions to Ordinance No. 39 on the principles and requirements for good distribution practice were developed and published. These amendments define the cases in which Wholesalers have to deactivate the code of medicines under article 23 of the Delegated Regulation (EU) 2016/161.

The European Medicines Verification System is a successful collaboration between the European Medicines Verification Organization (EMVO) and the 29 National organizations (NMVOs). The BgMVO team participates in several of the European working groups, with the aim of contributing to the common goal and exchanging good practices.

In 2023 BgMVO will continue in cooperation with the institutions, with all stakeholders of the drug supply chain and with other European organizations to work for a stable and reliable functioning of the Medicines Verification System, increasing the activity of pharmacies and effective alert management.