Press Release

Serialization and traceability of medications

• SICK AG and Arvato Systems work together to significantly increase the efficiency with which medications affected by the Falsified Medicines Directive (EU 2016161) are authenticated.
• The SICK Multi-code Reading System integrates the Arvato Smart Logistics Platform’s platbricks Healthcare Suite so that all common FMD operations can be applied to the scanned packages

Gütersloh, Germany – The Falsified Medicines Directive (abbreviated to “FMD”) stipulates that pharmaceutical wholesalers must verify the authenticity of every prescription medication. Arvato Systems has helped its wholesale clients comply with this directive with its platbricks Healthcare Suite since it came into force in February 2019. The Multi-code Reading System from SICK AG is now making this process even more efficient.

The EU Falsified Medicines Directive stipulates that, as of 9 February 2019, prescription medications may only be put into circulation if the packaging bears an individual serial number.

This serial number can be used to review the identity and authenticity of medication in order to prevent falsified medicine from entering the legal supply chain.

The introduction of this directive means that pharmaceutical wholesalers or manufacturers with a wholesale license are required to verify the authenticity of every medication that is to be serialized at least once. The scan communicates with the respective national verification system and the products can be verified as being authentic and unopened.

This process requires wholesale license holders or hospital pharmacies to incur significant additional costs, such as in the goods receipt or returns process, which are generally not remunerated separately. The increased number of package scans required in particular has led to calls for this process to be more efficient in the future. This means these companies are now asking: how can the costs be kept to a minimum while still complying with the rules set out in the FMD?

SICK AG has developed the Multi-code Reading System to make this process more efficient. This system can scan up to 200 medication packages in under five seconds. It is also integrated into the platbricks Healthcare Suite so that the packages are verified or decommissioned in compliance with the FMD after the scan has been completed. The user can select the required FMD operations directly on the device via the frontend and can start the scan with just one click. They can then transfer the scanned barcodes to the platbricks Healthcare Suite via a confirmation. If certain individual products have not been scanned correctly, the user can always scan these products again manually.

Arvato Systems has offered the platbricks Healthcare Suite to its clients since the Falsified Medicines Directive came into force to enable them to scan products that require serialization in compliance with the relevant regulations. “The Multi-code Reading System from SICK AG allows Arvato Systems to offer its clients additional ways to make their processes efficient while still complying with the FMD regulations,” says Stefan Lais, Project Manager MultiCodeReading System at SICK AG, of the new partnership with Arvato Systems.