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Italy’s new serialisation framework: navigating the transition to a hybrid model

Italy is entering a pivotal phase in pharmaceutical traceability. With the introduction of Decreto Legislativo n. 10 del 6 febbraio 2025, the country is reshaping its long-standing national system to align more closely with the European Union’s Falsified Medicines Directive (EU FMD), specifically Regulation (EU) 2016/161, which supplements Directive 2001/83/EC, while preserving elements of its established security infrastructure.

For sponsors and marketing authorisation holders, this is not a routine regulatory update. It is a multi-dimensional transformation affecting packaging, supply chains, data management and regulatory compliance.

Why is the framework changing?

Italy has historically operated one of Europe’s most robust national traceability systems, centred on the Bollino, a uniquely Italian security feature applied to medicinal packs.

While highly effective in preventing counterfeiting, this national system has operated in parallel to the EU FMD, which introduced harmonised requirements across Member States, including unique identifiers and verification through the European Medicines Verification System (EMVS).

The new legislation reflects a strategic shift. Its objectives are threefold:

  1. Strengthen supply chain security through harmonised EU mechanisms
  2. Enable interoperability with EU-wide verification systems
  3. Ensure continuity of the existing Italian safeguards during transition

The result is a hybrid model, designed to bridge national and European approaches without disrupting market supply.

What does the new regulation introduce?

Replacement of the Bollino

A key change is the progressive replacement of the Bollino with the Carta Valori, a secure value-based label produced by the Italian State Printing Office (Istituto Poligrafico e Zecca dello Stato). Unlike a simple sticker, Carta Valori is a controlled security document with enhanced anti-counterfeiting features and centralised production. 

EU-compliant pack requirements

Outer packaging must now include:

  • A 2D DataMatrix encoding: 
    • GTIN
    • Serial number
    • Batch/lot number
    • Expiry date
    • Italian AIC code
  • Human-readable data elements
  • An anti-tampering device (ATD) 

These requirements align Italy with broader EU FMD standards while retaining country-specific identifiers.

Timeline and key milestones

The legislation introduces a phased implementation:

  • 2025

    February 2025: Entry into force

  • 2026

    2025 to February 2027: Transition period with dual systems

  • 2027

    From February 2027: Full application of EU FMD requirements

During the transition, companies must ensure that packs comply with both EU and Italian requirements, increasing operational complexity.

What is the impact on industry?

Who is affected?

The regulation applies to:

  • Marketing authorisation holders
  • Manufacturers and contract manufacturing organisations (CMOs)
  • Packaging sites supplying the Italian market
  • Supply chain and distribution partners

Operational implications

The shift to a hybrid model introduces several challenges:

  1. Packaging and artwork redesign : Artwork must be adapted to include additional data elements and accommodate both the DataMatrix and national security features. 
  2. Packaging line modifications : Production lines may require upgrades to handle variable data printing, additional data fields, and physical application of Carta Valori labels. 
  3. Increased data management complexity : Data must be uploaded to the EU hub, validated, and transmitted to the Italian system. This creates a critical dependency on data accuracy and system connectivity. 
  4. Reliance on national suppliers : The availability of Carta Valori introduces a dependency on centralised production and distribution, with potential risks to supply timelines. 

Industry feedback indicates that serialisation in Italy is already seen as a significant operational pain point, reflecting the scale of the transformation.

What actions should sponsors take now?

To remain compliant and minimise disruption, early and structured preparation is essential. Key actions include:

  1. Identify products and sites supplying Italy
  2. Assess current serialisation capabilities against EU FMD requirements
  3. Review and update packaging configurations and artwork
  4. Validate production line readiness
  5. Ensure alignment of master data and connectivity to EMVS
  6. Engage early with CMOs and supply partners
  7. Monitor evolving national guidance and pilot programs

Participation in pilot phases and market testing is particularly valuable, enabling early identification of gaps and influencing implementation through feedback loops. 

ICON perspective: Practical recommendations for pharma companies

At ICON, we see this transition as both a compliance obligation and an opportunity to strengthen labelling and supply chain strategies.

1. Start early and prioritise Italy
Italy should be treated as a priority market given the scale of change and operational impact. Delayed planning increases the risk of bottlenecks as multiple companies compete for limited implementation capacity.

2. Take an integrated approach
Serialisation is not solely a regulatory activity. Success depends on alignment across:

Regulatory Affairs

Packaging and artwork

Supply chain

Quality and IT

Cross-functional governance is critical.

3. Build flexibility into packaging design
During the transition, packaging must accommodate evolving requirements. Designing adaptable artwork and layouts will help reduce rework and future-proof packs.

4. Strengthen data governance
Data quality and consistency are central to EU FMD compliance. Sponsors should establish robust controls to ensure accurate, validated data flows through the EU hub and national systems.

5. Mitigate supply chain risk
Engage early with suppliers of Carta Valori and packaging components. Build contingencies to manage potential delays or capacity constraints.

6. Leverage pilot programs
Active participation in pilots and testing phases provides valuable insights and allows companies to shape implementation through direct feedback to authorities and stakeholders.

How ICON can support

ICON supports clients through every stage of this transition, including:

  • Regulatory intelligence and interpretation of Italian requirements
  • Portfolio and supply chain impact assessments
  • Artwork and labelling strategy
  • Risk-based implementation planning
  • Coordination across global and local stakeholders

Our approach is grounded in practical experience, combining regulatory expertise with operational insight to deliver compliant and sustainable solutions.

Conclusion

Italy’s revised serialisation framework represents a significant evolution in pharmaceutical traceability. The hybrid model introduces complexity but also aligns Italy more closely with European standards while preserving its strong national safeguards.

For sponsors, success will depend on early planning, cross-functional collaboration and proactive engagement with the evolving system.

ICON continues to monitor developments closely and support clients in navigating this transition with confidence.

ICON supports clients across the full lifecycle of regulatory labelling and packaging transformation, from early impact assessment through to implementation and market compliance, helping organisations navigate regulatory changes with confidence in an evolving regulatory landscape. If you would like to know more about how to navigate the impact of the serialisation changes, please contact our team at RCSLabeling@iconplc.com.

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