Traceability, how to be compliant by 2027

Italy Serialization Decree 2025

ADAPTATION TO THE EU-FMD REGULATION

The future of pharmaceutical serialization in Italy

On January 28, 2025, the Italian Council of Ministers approved a new legislative decree that aligns Italy with the EU directive on falsified medicines.

The complete transition must take place by February 8, 2027.

During the two-year transition period 2025-2027, pharmaceutical companies can choose two different paths:

  1. continue with the existing Italian system (Bollino farmaceutico);
  2. switch immediately to EU FMD serialization, which includes the unique Data Matrix identifier, the anti-tampering labels (ATD), and the new Bollino farmaceutico.




Sara Napolitano, Italy Area Manager, explains the novelties of the new decree and the related advantages.
gazzetta ufficiale_dm

The novelties of the decree in brief

In Italy, the adoption of a serialization system compliant with European standards will replace the traditional Bollino.

The new elements are as follows:

  • Data Matrix Code: guarantees traceability and prevents counterfeiting;

  • Anti-tamper device (ATD): certifies the integrity of the packaging;

  • Centralized database managed by AIFA and the Ministry of Health for verification and reporting of UI codes.

 

What must the Data Matrix contain?

The Data Matrix is a two-dimensional optically readable code that must contain the following information:

- PC: product code, represented by the Global Trade Item Number (GTIN), a 14-digit numeric code that follows the specifications of the GS1 System;
- SN: serial number, represented by an alphanumeric code composed of up to 20 characters;
- LOTTO: manufacturing batch number, represented by an alphanumeric code of up to 20 characters;
- SCAD: expiration date, represented in YYMMDD format;
- AIC: marketing authorization number assigned by AIFA upon granting marketing authorization in Italy

The system will improve the management of the supply chain, reducing the risk of falsification, facilitating product recalls and increasing efficiency.
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codice data matrix

The human readable interpretation (HRI) are represented according to the GS1 specifications and facilitate the understanding of the information included in the optically-readable code, thanks to their human readable textual format.

Tabella application identifier

The Application Identifier (AI)

The Application Identifier (AI) are numeric prefixes that precede the data encoded in barcodes, specifying the type of information and format. These AIs are an integral part of the GS1 standard a global system widely used for managing product information. GS1 ensures product traceability and authenticity throughout the entire distribution chain, improving trade security and efficiency.

To better understand how the AIs are created, go to page 4 of the attachment on the Data Matrix specifications.

The new Pharmaceutical Label

On 15 July 2025 the new Bollino Decree officially came into force, Italy introduces a completely renewed security device for medicine packaging.

This new label, produced exclusively by the State Printing Works and Mint Institute, is a high-technology value paper that integrates visible and invisible anti-counterfeiting elements, guaranteeing even more effective protection against fraud.

Among the main novelties:

  • a unique identification code;
  • advanced security materials;
  • traceable digital management via the IPZS platform.

The Label is now an integral part of the European serialization and tamper prevention system, strengthening security along the entire distribution chain.

Decreto ufficiale Bollino
rilascio AIC

Procedures for the issuance of the A.I.C.

On 17 July 2025, the Determination containing the “Application Instructions” relating to the regulatory obligations incumbent on holders and applicants of marketing authorizations (AIC) or parallel import authorizations (AIP) was published on the AIFA website.

Our traceability solutions

Which systems will one need to equip oneself with to best manage thisnew serialization process?

We at SEA Vision are here to accompany you in this transition. We can provide you with the complete software for printing, from level 1 to 4. We offer scalable and configurable solutions for different control applications, guaranteeing compliance with the standards required by the European regulation to which Italy will have to adhere by 2027.

The solutions comply with the levels provided by ANSI/ISA 95 and consist of the following product families:

BL-A415S SPL Italia Sea Vision Generale

Level 4

Yudge

Software for Track & Trace that connects pharmaceutical companies and regulatory authorities, ensuring compliance with regulations.

Level 3

Yutrace

The core component of the SEA Vision serialization and Track & Trace solution handles data exchange between Level 4 (or other Level 3) systems and the packaging lines.

Level 2

Tracker

Software solution capable of performing runtime checks on serialized codes printed on pharmaceutical cartons, as well as aggregation operations with subsequent logistics units.

Livello 1

Automatic and semi-automatic machines

A comprehensive range of Print & Check labeling machines and aggregation systems for packaging and labeling.

BL-A415S

Among the various labeling solutions we off er for serialization systems, the BL-A415S model standout.

The BL-A415S is a continuous-motion labeling machine designed for printing and inspecting Data Matrix codes and human-readable data, as well as applying a vignette on the top face of the carton and two tamper-evident seals on its sides.

The unit operates in-line with other machines or as a standalone system when equipped with suitable infeed and outfeed accessories.

The core of the BL-A415S is the Tracker.

BL-A415S

⬇️Below you can find the materials used during our past webinars⬇️

WEBINAR May 7th 2024 (event concluded)

Download the presentation here

How will the Italian market evolve with the introduction of Made-in EU serialization? We discussed this on May 7, 2024, from 10:00 to 12:00
in an online webinar featuring a panel of industry experts.

The exemption granted to Italy is expiring, and by February 2025 all companies marketing pharmaceuticals in Italy must place serialized products on the market in accordance with EU FMD Directive2011/62/EU.

Is your company ready for this change? What steps must you take to upgrade your facilities to the new requirements and be prepared for the new directives without losing a single day of production?

Download here the presentations used by the speakers during the event.

SEA VISION SPEAKER 7 MAGGI_FINAL
sara napolitano-1

DOWNLOAD: "Direttiva anti contraffazione: lo stato dell’arte in Italia e gli ultimi aggiornamenti sulle modalità di applicazione"

giorgio bruno

DOWNLOAD: "Beyond Traceability: l’evoluzione della serializzazione e della tracciabilità del farmaco in Italia, la road map proposta dal gruppo di studio AFI"

luca paoles

DOWNLOAD: "Il ruolo di NMVO Italia, organismo per il contrasto alla contraffazione dei farmaci secondo il sistema europeo."

fabio ferrarini

DOWNLOAD: "L’offerta Marchesini Group per la serializzazione Italia: focus su soluzioni complete di Tamper Evident e Bilancia"

gianluca sala

DOWNLOAD: "Prepararsi alla scadenza: le implicazioni della tracciabilità. Come valutare i sistemi sulle linee esistenti"

Tuesday, May 7 (event concluded)

Agenda 

10:00-10:10 Opening of the session: 
Anti-Counterfeiting Directive – current status in Italy and the latest updates on implementation methods

Sara Napolitano, Area Manager Italy, SEA Vision

10:10-10:25 Beyond Traceability: the evolution of pharmaceuticalserialization and traceability in Italy, the roadmap proposed by the AFIstudy group

Giorgio Bruno, Presidente AFI - Associazione Farmaceutici Industria Società Scientifica  

10:25-10:45 Il ruolo di NMVO Italia, organismo per il contrasto alla contraffazione dei farmaci secondo il sistema europeo. The role of NMVO Italy, the National Medicines Verifi cationOrganization for combating pharmaceutical counterfeiting under theEuropean system

Massimo Gaiotto, Chairman of the Board of Directors,NMVO Italia scrl -
Luca Paoles, NMVO Italia scrl

10:45-11:00 The Marchesini Group’s off ering for serialization in Italy:focus on complete tamper-evident and checkweighing solutions

Fabio Ferrarini, Product Manager Marchesini Group Div. Neri

11:00-11:15 Preparing for the Deadline: Implications of Traceability. Howto Evaluate Systems on Existing Lines

Gianluca Sala, Business Development Manager SEA Vision

11:20-11:40 Survey 

11:40-12:00 Q&A with all speakers