The most impactful change from the Directive 2011/62 / EU on the counterfeiting of drugs regards packaging. NCF has discussed it with Federico De Franceschi, pharma Serialization, Track & Trace Operational Manager at Angelini.
“The Directive asks for the insertion of” safety devices “on the packaging, i.e. a unique identification number to be registered in a European portal and an anti-tampering device, so that the user will be sure to receive an authentic product. The most impactful change, as mentioned, is therefore on the packaging. The identification number will be inserted by inkjet technologies and the anti-tampering device will be applied directly on the production line”.
“The change incudes a graphic revision in almost all secondary packaging, while the interventions of the engineering part are already more limited”.
“The technologies used will remain the same. However, we will see an evolution of the printing systems which also accepts 100% verification of correct stamping”.
Rethink the end of line
“The end of line will be set up for reconciliation and, in some cases, for” total aggregation”. This could bring more data available for efficiency and organizational production studies, as well as the investments needed to digitize production data, will produce updates and innovations “.
“The investments are both in hardware and software. The machines will be integrated and / or replaced for the application of the new code: there will be important software investments to manage the amount of data and the security of their management”.