EDQM will help assess European medicines traceability platform

A stakeholder-proposed system for verifying medicines in the EU will be put through its paces by the Council of Europe's healthcare directorate.

The European Directorate on the Quality of Medicines & Healthcare (EDQM) had been developing its own traceability model - known as eTACT - but has now agreed to perform conformity assessments for the European Medicines Verification Organisation (EMVO).

The EMVO is a non-profit organisation set up by bodies representing the pharmaceutical, wholesaler, parallel importer and pharmacy sectors, which will oversee a system that aims to meet the safety feature requirements of the Falsified Medicines Directive.

According to the recently-adopted delegated act on safety features, medicines in the EU must carry a serialised unique identifier (UI) code within a 2D datamatrix barcode, an anti-tampering device on the outer packaging, and be verified at the point of dispensing to the patient.

Specifically, the EMVO is tasked with overseeing the European Medicines Verification System (EMVS) hub, a platform that will handle the transactional data generated as medicine packs bearing the unique identifiers move from manufacturer to patient.

EDQM will determine whether the EMVO European hub and blueprint systems are "designed, managed and operated in accordance with the standards described in the delegated act."

In a joint statement, the two organisations noted that the EDQM is "world renowned for its quality standards in the field of medicines and healthcare."

"The conformity assessments will provide a useful support to member states for their future supervisory responsibilities under the delegated act," they added.