[Blog] Italy’s Serialization Update: Key Requirements and What It Means for Pharma Companies
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Italy’s Serialization Update: Key Requirements and What It Means for Pharma Companies
Italy has significantly strengthened pharmaceutical compliance with the first implementing decree under the Falsified Medicines Directive (FMD). The decree mandates using a 2D Data Matrix barcode on secondary packaging, aligning with EU serialization standards.
This update requires operational changes, data management updates, and packaging line adjustments for pharmaceutical manufacturers to ensure compliance. But what exactly does this decree entail, and what steps should companies take to prepare?
Let’s break down the key elements and explore their impact on serialization, supply chain integrity, and compliance strategy.
Key Requirements of the Italian Serialization Decree
The Ministerial Decree sets a clear technical specifications for affixing and verifying the unique identifier (UI) on medicine packaging. Here’s what companies need to know:
Mandatory 2D Data Matrix Barcode
All pharmaceutical products marketed in Italy must carry a 2D Data Matrix barcode, except those exempt under Annex I of EU Regulation 2016/161.
Data Encoding Standards
The barcode must follow GS1 standards and comply with ISO/IEC 16022:2006. The following information must be encoded:
- GTIN (AI 01): 14-digit product identifier
- Serial Number (AI 21): Up to 20 characters (alphanumeric)
- Batch Number (AI 10): Up to 20 characters (alphanumeric)
- Expiration Date (AI 17): YYMMDD format
- AIC Code (AI 716): Unique 9-digit identifier assigned by the Italian Medicines Agency
Human-Readable Interpretation (HRI)
All encoded information must also appear in a human-readable format to support manual verification in case of scanning issues. This ensures:
- Faster visual validation
- Improved traceability in case of technical failures
- Compliance with EU serialization guidelines
Printing & Packaging Compliance
The 2D Data Matrix must be printed on a smooth, non-reflective surface, adhering to technical specifications outlined in Annex A of the decree. Poor-quality printing can lead to rejection at verification points, so barcode readability and accuracy are critical.
What This Means for Pharma Companies
For pharmaceutical manufacturers and Marketing Authorization Holders (MAHs), compliance isn’t just about adding a new barcode—it’s about ensuring that serialization data flows seamlessly across the supply chain. Here are three key considerations:
Impact on Packaging & Production Lines
Companies must update their packaging lines to support the printing and verification of 2D Data Matrix codes, ensuring:
- Proper placement and print quality on packaging
- Seamless integration with existing serialization solutions
- Real-time verification processes to prevent errors
Data Integrity & IT System Readiness
Serialization is only as strong as the data behind it. IT systems must be capable of:
- Generating, managing, and verifying serialized data
- Ensuring real-time reporting for regulatory audits
- Securely storing and exchanging data with national and EU repositories
Compliance Deadlines & Transition Period
While the decree is now official, companies must align their operations within the designated stabilization period. Proactive compliance planning will prevent last-minute disruptions.
The Bigger Picture: Beyond Compliance
While this is a regulatory requirement, it also presents an opportunity for digital transformation. Companies that go beyond compliance and invest in robust serialization and supply chain digitalization strategies will benefit from:
- Enhanced supply chain visibility
- Reduced counterfeit risks
- More efficient recalls and product tracking
Is your serialization strategy ready for this transition? SoftGroup is here to help if you need a scalable, compliant solution to meet Italy’s requirements.
Want to ensure your pharmaceutical operations meet compliance standards? Contact us today!