Preparing for Pharmaceutical Traceability

The European Directorate for the Quality of Medicines & Healthcare (EDQM) has developed a service to support nonproprietary solutions for pharmaceutical traceability. EDQM's system is intended to serve as a public service for product verification, explains Francois-Xavier Lery in EDQM's Department for Biological Standardisation, OMCL Network and HealthCare (DBO). "Live demonstrations mimicking the supply chain using ERP software powered by SAP and IBM are expected later this year," he explains.

While the EDQM system is intended to "capture product information from packages as well as on shipping," he explains, "it is not an electronic pedigree system and can support an end-to-end approach. But the scope goes beyond to enable patients to conduct verification such as through a smart phone."

The public organization in charge of maintaining the European Pharmacopeia has developed the project in order to help EU member countries comply with the Falsified Medications Directive, explains Lery, but could serve more than just the 27 members. "Our concept service is intended to reach 36 member states of the European Pharmacopeia," he says.

EDQM plans to offer training and implementation strategies, Lery explains. "We propose the use of a public system to address counterfeiting medical products and similar crimes. Our efforts behind this traceability service also include the Medicrime Council of Europe's convention, multisectorial training for government officials and our campaign against illegal Internet sites and spam," he says.

For more details, read the full PDF here.

Back to Home