The European Directorate for the Quality of Medicines & HealthCare (EQDM) has begun Phase 2 of its “track & track” anti-counterfeiting strategy and is seeking manufacturer participation.
The overall aim is to develop a labelling system that uses a unique medicine identifier (UMI) in a 2D data matrix code to monitor the movement of pharmaceutical products through the European supply chain.
Technical challenges
The demo will use IBM developed middleware, software designed to work on a range of systems, which is key to overcoming the challenge of creating a system that can operate in all 36 European Union member states.
“The main technical hurdles are to develop a system flexible enough to accommodate the different constraints from the authorities and business stakeholders [without] creating additional constraints.
To give a basic but crucial example, the operation of scanning a product when dispensing is not an additional constraint if it’s integrated without noticeable response time within the Point–of-Sales system of the pharmacy, but it would be if there were a need for a second scan.”
The EDQM plans to demonstrate the technology at public workshops to be held later this year in a bid to garner feedback from industry and regulatory agencies ahead of the launch, and the EDQM hopes, adoption of the live system in 2012.