--- title: "Italy’s Pharmaceutical Traceability: Stabilization Period" description: Italy extends its pharmaceutical traceability stabilization period to Feb 2027. Understand what this means for MAHs, serialization, and EU FMD compliance. image: https://blog.cosmotrace.com/hubfs/Italy%20Pharmaceutical%20Traceability%20-%20Jul%204%20-%20Featured%20Image.jpg --- +44 203 097 1597 [info@cosmotrace.com](mailto:info@cosmotrace.com) - - - - [![Cosmotrace](https://blog.cosmotrace.com/hs-fs/hubfs/raw_assets/public/CosmoTrace_Oct2021/images/cosmotrace-2.png?width=630&height=209&name=cosmotrace-2.png "Cosmotrace")](https://www.cosmotrace.com/) - [Home](https://www.cosmotrace.com/) - [About Us](https://www.cosmotrace.com/about-us/) - [Careers](https://www.cosmotrace.com/pages/careers/) - [Services](https://www.cosmotrace.com/our-services/) - Compliance Focused - [Misalignment Exceptions Management (US DSCSA)](https://www.cosmotrace.com/our-services/misalignment-exceptions-management-us-dscsa/) - [EU Alert Management](https://www.cosmotrace.com/our-services/eu-alert-management/) - [Middle East Serialization Consulting](https://www.cosmotrace.com/our-services/middle-east-serialization-consulting/) - [China Reporting Services](https://www.cosmotrace.com/our-services/china-reporting-services/) - Business Operations Focused - [Master Data Management](https://www.cosmotrace.com/our-services/master-data-management/) - [Trade Partner Onboarding](https://www.cosmotrace.com/our-services/trade-partner-onboarding/) - [Level 4 System Validation](https://www.cosmotrace.com/our-services/level-4-system-validation/) - [Serialization System Health Check](https://www.cosmotrace.com/our-services/serialization-system-health-check/) - Business Processes Outsourcing - [Managed Services CoE](https://www.cosmotrace.com/our-services/managed-services-coe/) - [US DSCSA Ti Digitization](https://www.cosmotrace.com/our-services/us-dscsa-ti-digitization/) - [Our Solutions](https://www.cosmotrace.com/solutions/) - [Traceware](https://www.cosmotrace.com/solutions/traceware/) - [nTrack](https://www.cosmotrace.com/solutions/ntrack/) - [Clients](https://www.cosmotrace.com/clients/) - [Blog](https://www.cosmotrace.com/blog/) - [Serialization](https://www.cosmotrace.com/blog/serialization) - [Digital](https://www.cosmotrace.com/blog/digital) - [News](https://www.cosmotrace.com/blog/news/) - [Contact](https://www.cosmotrace.com/contact-us/) - - - - - [Home](https://www.cosmotrace.com/) - [About Us](https://www.cosmotrace.com/about-us/) - [Careers](https://www.cosmotrace.com/pages/careers/) - [Services](https://www.cosmotrace.com/our-services/) - Compliance Focused - [Misalignment Exceptions Management (US DSCSA)](https://www.cosmotrace.com/our-services/misalignment-exceptions-management-us-dscsa/) - [EU Alert Management](https://www.cosmotrace.com/our-services/eu-alert-management/) - [Middle East Serialization Consulting](https://www.cosmotrace.com/our-services/middle-east-serialization-consulting/) - [China Reporting Services](https://www.cosmotrace.com/our-services/china-reporting-services/) - Business Operations Focused - [Master Data Management](https://www.cosmotrace.com/our-services/master-data-management/) - [Trade Partner Onboarding](https://www.cosmotrace.com/our-services/trade-partner-onboarding/) - [Level 4 System Validation](https://www.cosmotrace.com/our-services/level-4-system-validation/) - [Serialization System Health Check](https://www.cosmotrace.com/our-services/serialization-system-health-check/) - Business Processes Outsourcing - [Managed Services CoE](https://www.cosmotrace.com/our-services/managed-services-coe/) - [US DSCSA Ti Digitization](https://www.cosmotrace.com/our-services/us-dscsa-ti-digitization/) - [Our Solutions](https://www.cosmotrace.com/solutions/) - [Traceware](https://www.cosmotrace.com/solutions/traceware/) - [nTrack](https://www.cosmotrace.com/solutions/ntrack/) - [Clients](https://www.cosmotrace.com/clients/) - [Blog](https://www.cosmotrace.com/blog/) - [Serialization](https://www.cosmotrace.com/blog/serialization) - [Digital](https://www.cosmotrace.com/blog/digital) - [News](https://www.cosmotrace.com/blog/news/) - [Contact](https://www.cosmotrace.com/contact-us/) - - - - # Italy’s Pharmaceutical Traceability: Stabilization Period Jul 4, 2025 | ![Italy’s Pharmaceutical Traceability: Stabilization Period](https://blog.cosmotrace.com/hubfs/Italy%20Pharmaceutical%20Traceability%20-%20Jul%204%20-%20Featured%20Image.jpg) 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: 1. ### 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. 1. ### 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). 1. ### 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. 1. ### 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**](mailto: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: 1. **Product Code (GTIN)** 2. **Serial Number** 3. **Expiry Date** 4. **Lot Number** 5. **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. ##### How can CosmoTrace help? We provide serialization consulting, implementation & integration services to help our clients with managing the end-to-end serialization projects and preparing them for the existing and upcoming regulations across the globe. We are well versed with the compliance regulations for various markets and can help you with implementing the global pharmaceutical serialization requirements. Our team of experts strategize and plan end-to-end solutions using a combination of years of knowledge in product serialization, pharmaceutical supply chains, life sciences and brand integrity. ##### 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. [Book a free consultation call](https://services.cosmotrace.com/italy-pharmaceutical-traceability-stabilization-2027)   #### Search #### Recent Posts - [Egypt’s Pharmaceutical Track and Trace - From 2019 Pilot to 2025 Nationwide Mandate](https://blog.cosmotrace.com/serialization/egypt-pharma-traceability-2025-mandate) - [Algeria’s 2027 Pharmaceutical Serialization & Aggregation](https://blog.cosmotrace.com/serialization/algeria-2027-pharmaceutical-serialization-aggregation) - [Serialization and Traceability in the Middle East: Navigating a Complex Compliance Landscape](https://blog.cosmotrace.com/serialization/middle-east-serialization-traceability-compliance) - [Sri Lanka Extends Barcode Grace Period for Medicines: What MAHs Need to Know](https://blog.cosmotrace.com/serialization/sri-lanka-barcode-grace-period-extension) - [DSCSA Enforcement Timeline: What Trading Partners Need to Know in 2025](https://blog.cosmotrace.com/serialization/dscsa-enforcement-timeline-2025) - - - - © 2020 CosmoTrace - part of ZeeInx Group