Italy continues its structured transition towards full compliance with the EU Falsified Medicines Directive (FMD), and now, a critical update has been confirmed. The stabilization period will extend until February 8, 2027. This extension provides much-needed clarity and a more manageable timeline for stakeholders across the pharmaceutical supply chain.
Key Update: Continued Use of the "Bollino" Until 2027
One of the most notable developments is the confirmed possibility to continue using the traditional Italian “bollino” (security label) for the release of pharmaceutical batches throughout the stabilization period. This decision ensures a safe, controlled, and deeply tested adoption of the new EU-compliant traceability framework, allowing all parties ample time to adapt without disrupting product availability or safety standards.
Revised Implementation Roadmap
Italy’s integration into the broader European traceability system is moving ahead in structured phases. Below is a breakdown of the updated rollout plan:
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Italian NMVS Connection to the EU Hub (October 2025)
The Italian National Medicines Verification System (NMVS) is expected to connect with the EU Hub during the IOT (Interface Operational Testing) window in October 2025. This marks a critical technical milestone, enabling the transmission and verification of serialized medicine data across EU member states.
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Performance Qualification Testing – “Pilot Phase” (Until Spring 2026)
Following the EU Hub connection, a pilot phase will begin, involving a select group of supply chain actors — from manufacturers to distributors to pharmacies. This phase is designed to validate the system’s performance in real-world conditions and ensure all operational and technical parameters are met.
The pilot is expected to run until spring 2026, subject to confirmation by the National Competent Authorities (NCAs).
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Progressive Opening – “Hypercare” Phase (Through End of 2026)
After successful pilot validation, Italy will enter the “Hypercare” phase, a progressive rollout to all stakeholders under close monitoring. This period will last through December 2026 and includes dedicated support structures and detailed procedures to ensure smooth onboarding and operation.
The specific guidelines governing the Hypercare phase are currently under discussion and will be finalized with input from the NCAs.
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Stabilization Period (Early 2027)
By early 2027, the expectation is that the implementation will be complete, stable, and fully operational. During this stabilization period, it is essential that all Marketing Authorization Holders (MAHs) are fully onboarded and actively contributing to the NMVS ecosystem.
Mandatory Onboarding for MAHs
All MAHs (Titolare AIC) with products in the Italian market falling under FMD scope are required to onboard to NMVO Italia. This includes:
- Signing the Onboarding Agreement, which will be standardized across all MAHs.
- Paying the Entrance Fee (collection already in progress), followed by ongoing Annual Fees to support system operations.
MAHs that have been contacted by NMVO Italia are urged to complete onboarding procedures as soon as possible. Those who haven’t received communication yet are advised to reach out proactively via onboarding@nmvo-italia.it.
Serialization & Packaging Requirements
Each pharmaceutical package must carry a Unique Identifier (UI) encoded in a GS1 DataMatrix, containing the following data elements:
- Product Code (GTIN)
- Serial Number
- Expiry Date
- Lot Number
- AIC Number (Italian-specific authorization code)
- All elements except the AIC must also be printed in Human-Readable Interpretation (HRI) format.
- The AIC number should appear next to the DataMatrix, and may be pre-printed on the packaging.
The Anti-Tampering Device (ATD) must comply with standards used in other FMD-regulated countries.
Security Feature: Dispositivo di Sicurezza in Carta Valori
In addition to the standard FMD requirements, Italy mandates a special security paper feature (Carta Valori) to enhance product integrity. As outlined in Decree No. 10 (February 6, 2025):
- This paper-based security feature remains mandatory for now.
- Future digital alternatives are under investigation.
- Final technical specifications will be outlined in upcoming decrees by the Ministry of Health.
Final Thoughts
Italy’s phased and pragmatic approach to FMD implementation balances regulatory compliance with operational readiness. The extended stabilization period to February 2027 provides a unique opportunity for the entire supply chain to transition smoothly while maintaining the country’s longstanding focus on product authenticity and patient safety.
Stakeholders are strongly encouraged to act promptly, ensure full compliance with onboarding requirements, and stay informed as Italy moves toward full harmonization with the EU serialization framework.
Stay tuned for the next blog in our series as we may come up with critical updates from another EU country.
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Disclaimer
This information is being provided ‘As Is’ with no claims of suitability for a particular purpose. It represents just one possible interpretation of information available in the public domain or through membership organizations, and that interpretation is subject to change. This information does not constitute legal advice. Users must refer to the source material for the complete requirements and form their own interpretation before making business decisions. Please use the references below to follow the updates at the source.