From 2027, companies operating in Italy’s pharmaceutical distribution sector will be required to adopt the Data Matrix code on product packaging, as set out in Legislative Decree No. 10 of 6 February 2025.
This is a more advanced two-dimensional code than the traditional barcode, capable of containing a significantly greater amount of information. Some players in the sector have already started pilot projects to prepare for the transition, introducing this code on packaging in order to test their systems well ahead of the regulatory deadline.
The most important operational issue concerns the hardware devices used in warehouses: not all terminals currently in use are able to read two-dimensional codes.
For large pharmaceutical distributors, managing complex warehouses with hundreds of operators and devices, this translates into a very concrete and urgent question: how many of the devices currently in operation are compatible with the new standards? And how many will need to be upgraded or replaced?
We may be talking about hundreds of terminals for a single organisation, with significant financial implications that require proper planning and enough lead time.
2027 may seem a long way off, but anyone working in pharmaceutical logistics knows that upgrading a hardware fleet of this size takes time: device mapping, compatibility assessment, investment planning, testing and operational rollout.
Starting this analysis early means being able to manage the transition gradually and in a controlled way- rather than scrambling to meet the regulatory deadline with last-minute emergency action.
From a regulatory perspective, failure to comply with the Decree exposes companies to penalties and the risk of disruption to distribution operations.
From a commercial perspective, not being aligned with the standards required by supply chain partners can lead to lost contracts, exclusion from tenders, and reputational damage with customers and suppliers.
In a sector where product traceability is a safety requirement even before it is a regulatory one, delaying compliance is simply not a sustainable option.
The Data Matrix code is applied to each individual pack. This means the hardware upgrade issue does not arise in the same way for everyone. If handling takes place at pallet or case level, warehouse systems work with aggregate labels that identify the contents without needing to scan each individual box. In that case, upgrading terminals is not a priority issue for the manufacturer.
The picture changes when the commercial model includes direct delivery to pharmacies or the management of orders at single-pack level. At that point, the ability to read the Data Matrix on each individual unit becomes essential at every stage of the logistics process—from the warehouse through to final delivery.
For over 30 years, Aton has worked alongside leading companies in Italian pharmaceutical manufacturing and distribution, supporting them in the management and evolution of warehouse operational infrastructures, and helping them tackle complex technology upgrade projects—where hands-on experience and a deep understanding of real processes make the difference.
We do not offer off-the-shelf solutions. We always start with a practical mapping of the current situation, in order to identify the most effective path towards regulatory compliance.
Is your hardware fleet already compatible with Data Matrix reading? Have you started an internal assessment?
If the answer is not immediate, it may be worth opening a discussion before the deadline gets too close.