Traceability, how to be compliant by 2027

Italy Serialization Decree 

ADAPTATION TO THE EU-FMD REGULATION

The future of pharmaceutical serialization in Italy

By 8 February 2027, Italy will adopt the system required by the EU Falsified Medicines Directive, transitioning from the current pharmaceutical sticker system for prescription medicines to an integrated model combining Data Matrix codes, human-readable serialized data, AIC code, tamper-evident device (ATD), and the new Carta Valori.

During the 2025-2027 transition period, companies may either continue using the current Pharmaceutical Sticker system or switch to EU FMD serialization. No changes are envisaged for OTC and SOP medicines, which will continue to use the Italian pharmaceutical sticker and tamper-evident device (ATD).

To be fully compliant by 8 February 2027, companies will need to ensure regulatory compliance, upgrade production lines, and review packaging designs.





timeline serializatio italy
gazzetta ufficiale_dm

The decree at a glance

Italy will introduce a serialization system compliant with European standards, replacing the traditional Pharmaceutical Sticker. The key elements are:

  • Data Matrix code: ensures traceability and helps prevent counterfeiting;
  • Tamper-Evident Device (ATD): verifies package integrity;
  • Carta Valori: incorporates advanced security features;
  • Centralized database: managed by AIFA and the Ministry of Health for the verification and reporting of unique identifiers.

 

What must the Data Matrix contain?

Il Data Matrix è un codice bidimensionale a lettura ottica che contiene:

  • PC (GTIN): codice prodotto a 14 cifre secondo gli standard GS1;
  • SN: numero di serie alfanumerico fino a 20 caratteri;
  • Lotto: numero di lotto di fabbricazione alfanumerico fino a 20 caratteri;
  • Scadenza: data nel formato AAMMGG;
  • AIC: codice autorizzativo rilasciato da AIFA.
 
Tabella application identifier
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.

The new Carta Valori

The key difference between the Italian system and the broader European framework is the introduction of the Carta Valori, which must be applied alongside the Data Matrix code and human-readable serialized data on the carton.

The new Carta Valori will:

  • be produced exclusively by IPZS (Italian State Mint and Polygraphic Institute);
  • be manufactured using high-security materials;
  • include visible and covert anti-counterfeiting features;
  • be linked to a unique identifier;
  • be digitally managed through the IPZS platform.

For in-line inspection, the Carta Valori can be verified either through the black mark (including sensor-based detection) or by reading the Code 128 barcode.

codice data matrix
Carta Valori_serializzazione Italia (3)

Impact on packaging production lines

The introduction of the Carta Valori requires several operational changes:

  • application on the top flap of the carton;
  • implementation of dedicated vision inspection systems, where not already available;
  • potential packaging layout redesign;
  • artwork modifications;
  • packaging line upgrades;
  • integration of new inspection systems.

> Companies already serializing for the Italian market

Impact generally lower due to the space already reserved to Italian Bollino.

> Companies entering the Italian market for the first time

Artwork, packaging configurations, and in-line inspection systems may need to be updated.

 

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 closed)

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.

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"

sara napolitano-1

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

Tuesday, May 7 (event closed)

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

11:20-11:40 Survey 

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