Italy's Transition to EU Serialization: What Pharmaceutical Companies Need to Know Before 2027.
Written by Olga Mezentseva, Associate Director, Supply Chain Excellence, and Julia Fuentes Maestro, Supply Chain Serialization Specialist.
For years, Italy has been an exception within the European pharmaceutical landscape. While most EU countries implemented the Falsified Medicines Directive (FMD) in 2019, Italy had a well-established anti-counterfeiting and traceability system in place. The Bollino ID system has been used for decades, which is why Italy was granted a later transition timeline.
That will change on 9 February 2027, when serialization becomes mandatory for both prescription and non-prescription medicines and will require careful preparation to ensure compliance and maintain supply continuity.
At a glance
- Go-live date: 9 February 2027
- Scope: RX and OTC products
- Key requirements: Serialization, Data Matrix, anti-tampering measures and Italian-specific security features (Carta Valori)
- Affected stakeholders: Market Authorization Holders, Manufacturers, Contract Manufacturing Organizations, Wholesalers and supply chain partners
What will change in 2027?
From 9 February 2027, products placed on the Italian market will need to comply with the new serialization framework.
Key requirements include:
- A unique serial number at pack level.
- A GS1 (Global Standards 1) compliant Data Matrix containing product and traceability data.
- Anti-tampering measures to help ensure package integrity.
- Integration with verification systems supporting product authentication.
- Compliance with specific Italian requirements alongside the European framework.
The transition is not only an industry effort. Italy is actively building the infrastructure required to support the new system, the organization responsible for implementing and managing the National Medicines Verification System (NMVS). From May 11, 2026 NMVS is officially connected to the EMVS (EU-HUB) production environment
This combination of local and EU requirements adds an additional layer of complexity compared with many other European markets.
Beyond compliance: preparing for implementation
For many companies, compliance will require much more than updating packaging artwork. Successful implementation depends on accurate master data, system readiness, serialization data exchange and close alignment between MAHs, manufacturers and supply chain partners.
Organizations should focus on five key areas:
- Assessing portfolio readiness
- Seeking expert advice as required/needed
- Reviewing packaging and artwork requirements
- Aligning supply chain partners
- Accelerating system preparation
Companies that start early will be better positioned to identify gaps, reduce implementation risks and avoid potential supply disruptions as the deadline approaches.
Partnering for readiness
At Medis, preparations are well advanced. Having maintained compliance with EU serialization requirements since 2019 across European markets, we are executing a dedicated Italy Serialization Project focused on packaging readiness, data connectivity, and customer collaboration.
As Italy joins the harmonized European verification network, we remain focused on ensuring a seamless transition for customers while continuing to support a safe, transparent, and secure pharmaceutical supply chain.
