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 track and trace 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.
Project leader Francois-Xavier Lery told Outsourcing-Pharma.com that Phase 2 involves the development of a “live demo” version of the system designed to show how it will work in practice.
“It will illustrate the proposed features of the future system playing different scenarios of normal and regular distribution and scenarios of counterfeiting in the legitimate supply chain.”
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 as Dr Lery explained.
“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.”
Lery also stressed the importance that the system can accommodate the different product numbering systems used to identify pharmaceutical products throughout Europe, such as CIP in France and PZN in Germany.
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.
“We hope governments and drug manufacturers to volunteer to be part of it by deploying the solution in a number of countries ranging from 1 to 36, through pilot phases first and then in a phased manner.”