As of January 28, 2025, Italy officially joins the rest of Europe in adopting full pharmaceutical serialization, aligning with EU Regulation 2016/161. For pharma manufacturers, distributors and CMOs operating in Italy, this is more than a regulatory milestone: it's a digital transformation opportunity.
At the heart of this shift is the Data Matrix Code, a small square with a big job: ensuring every medicine package is unique, traceable, and verifiable.
Why is this a big deal?
While most EU countries implemented serialization in 2019, Italy was granted a temporary exemption, due to its existing "Bollino" system, a uniquely Italian anti-counterfeiting label that had already ensured strong traceability.
Now, with the new decree in force, Italy is strategically aligning with the European serialization framework, including the mandatory use of anti-tampering devices in line with EU FMD regulations. However, the Bollino remains a national requirement, continuing to coexist with EU-wide measures to ensure compliance with both national and European traceability standards. 
What is the Data Matrix Code?
It all starts with the Data Matrix, a 2D barcode printed on every pack of medicine. It carries:
PC: Product Code (14-digit GTIN).
SN: Serial Number (up to 20 characters).
LOT: Manufacturing lot number.
SCAD: Expiration date (YYYYMMDD).
AIC: Marketing authorization number from AIFA.
Each code is also printed in plain text (HRI, Human Readable Interpretation) for easy reading. This system allows real-time verification from production to pharmacy, improving safety, recalls, and inventory management. Even so, Italy is going further.
What’s new in Italy’s serialization system?
Italy's approach is a mix of EU-wide compliance and local enhancements.
Alongside the Data Matrix, the new system includes:
🔐Anti-tampering devices (ATDs) to protect packaging
Every box needs a visible security feature, like a seal or a sticker, that shows if it's been opened or altered. The mixture between physical and digital guarantees smarter protection.
💡A new chapter for the Bollino
Italy's classic Bollino is getting a significant makeover. Printed on high-security paper and produced exclusively by the IPZS, this self-adhesive sticker is applied directly to the outer packaging of medicines, in a position chosen by the manufacturer. It’s designed to stay firmly in place for the entire life of the product. If someone tries to tamper with it, the label will tear or visibly deteriorate, making any attempt at removal immediately obvious.
Under the new regulation, the Bollino will include an internal number generated by IPZS (Istituto Poligrafico e Zecca dello Stato). It is crucial to clarify that the number on the new Bollino has no link to the serialization code contained in the Data Matrix, which is the one required by the EU FMD (Falsified Medicines Directive). This distinction is essential to prevent misunderstandings among stakeholders in the pharmaceutical supply chain.
📊Centralized national database
Serialized codes you see on Datamatix must be uploaded to the EMVS hub. This system will logically sync with Italian NMVS Hub all the codes belonging to Italian-market batches, so Italian distributors and pharmacies can query national database to verify, dispense or destroy a package. If the Italian system is requested to update the status of an item, it synchronizes back to European repository, so data flows in both directions.
Italy's serialization rollout timeline
The main steps will be the following ones:
| Date | What's happening |
| Q4 2025 | Italy connects to the EU’s EMVO hub |
| End 2025 – Summer 2026 | Pilot phase with selected pharma stakeholders |
| Summer – Q4 2026 | “Hypercare” phase for full ecosystem testing |
| February 8, 2027 | Official go-live of the centralized serialization system. |
Ready-to-use serialization solutions
Pharma companies must now adopt systems to generate, print, verify, and transmit serialized codes. Solutions like Marchesini Group’s BL-A415, integrated with SEA Vision software suite, offer end-to-end serialization, from ERP to Data Matrix printing till EMVS integration.
If you are looking for more in-depth details, such as the full text of the decrees, technical specifications, or how the transition will impact your business, visit our dedicated page on serialization in Italy.
Conclusion
The Data Matrix is not just a code: it is the key to a more secure, transparent, and digital pharmaceutical supply chain. It makes each package unique, traceable and verifiable, helping to protect patients from counterfeit drugs and improving the efficiency of the entire healthcare system.
For companies, it represents a technological challenge but also a concrete opportunity to innovate production processes, optimize logistics and strengthen their competitiveness in the European market.
