Falsified Medicines Barcode Aggregation Service
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Key information
Overview
The HSE intends to establish new contracts with United Drug (Wholesale) Limited and Uniphar Wholesale Limited to provide a barcode aggregation service for medicines subject to Falsified Medicines Directive (FMD) that are supplied to hospital pharmacies. Due to technical, legal, and operational constraints, only these wholesalers can perform aggregation on their own stock, making a competitive tender impractical and justifying a negotiated procedure under EU Directive 2014/24/EU. FMD requires packs of medicines subject to this legislation to be uniquely identified (serialised), verified, and decommissioned before use, ensuring authenticity, traceability, and patient safety. However, scanning every individual pack creates significant workload in hospitals. Aggregation addresses this by linking multiple medicine packs in a tote to a single barcode, allowing hospital staff to verify all contents of the tote with one scan. This improves efficiency, reduces manual effort and errors, while maintaining full compliance with FMD requirements. Ireland’s regulated medicines supply chain relies heavily on wholesalers, who distribute medicines in consolidated deliveries. Previous HSE aggregation contracts with these wholesalers have expired, and new agreements are now required to continue this service.
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Falsified Medicines Barcode Aggregation Service (notice).pdf
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