Traceability: EDQM is Making Progress Towards the Implementation of eTACT

Traceability is on everyone's lips. Directive 2011/62/EU - the so-called Counterfeit Directive - calls for the introduction of so-called safety features to enable authenticity verification and the identification of individual packages. The Directive has provided no provisions about how such a system should look like. Different organisations are currently checking the realisation - among them: EFPIA, SecurPharm and the EDQM.

All these systems are based on so-called 2D Matrix Codes to be applied on the packaging. Yet, there exist different models for the technical implementation and especially for the IT implementation. Some models support the "end to end" model whereas others prefer a comprehensive traceability, which enables the verification of the authenticity of a medicinal product at any time and any step of the supply chain and not only at the end (in the pharmacies).

In a current press release, the EDQM has announced that the eTACT system is making further progress. During a series of workshops organised with various stakeholders, the EDQM could further develop the live demo system and has implemented a Point-of-Sale system (to be used in pharmacies) with an interface to the eTACT system. The EDQM system seems to be a very promising system for the introduction of a publicly-governed traceabilty model on European scale.

To find out more please read the information about the latest EDQM workshop. Further workshops are planned. You can register on the EDQM website.