Italy Extends Pharmaceutical Packaging Compliance Deadline to 2027: How Kevision Ensures Your Readiness

The Italian Medicines Agency (AIFA) has officially extended the compliance deadline for pharmaceutical packaging regulations from 9 February 2025 to 16 February 2027. This decision provides pharmaceutical manufacturers additional time to align with GS1 serialization and aggregation standards while enhancing drug traceability and patient safety.

Understanding the AIFA Regulation Extension
The regulatory framework issued by AIFA aligns Italy's pharmaceutical packaging with the EU Falsified Medicines Directive (FMD). The deadline extension to 2027 reflects the industry's need for additional time to fully integrate GS1 standards into their packaging lines.
These guidelines are mandatory for all pharmaceutical products and focus on:
✅ Serialization Requirements for Secondary Packaging (Cartons)
• Barcode Type: GS1 Datamatrix
• Data Requirements: GTIN, Expiry Date (YYMMDD format), Batch Number, Serial Number
• GS1 Encoding Compliance
• No Serial Number Randomization Required
✅ Aggregation for Tertiary Packaging (Shippers)
• Barcode Type: GS1-128 linear
• Data Requirements: GS1 GTIN (optional), Lot Number, Expiration Date, GS1 SSCC (Serialized Shipping Container Code)
• Aggregation Mapping: Parent-child data capture not mandatory

How Kevision Helps You Stay Compliant
Kevision's Track & Trace solutions https://kevision.in/kevsecure-l4/ provide a future-proof approach to serialization and aggregation, ensuring seamless regulatory compliance ahead of the 2027 deadline. Here's how:
🔹 GS1-Compliant Serialization - Kevision's technology ensures accurate encoding of GTINs, batch numbers, and expiry dates in GS1-standardized barcodes.
🔹 High-Speed Aggregation - Our advanced camera-based inspection systems validate and link packaging levels effortlessly.
🔹 Seamless Data Exchange - Enables smooth reporting to regulatory authorities and trading partners.
🔹 Effortless Integration - Works with existing packaging infrastructure without major system overhauls.
Why This Extension Matters for Pharma Manufacturers
The additional two years granted by AIFA allow manufacturers to:
✔ Upgrade Serialization & Aggregation Systems - Implement GS1-compliant solutions without disrupting operations.
✔ Streamline Compliance Processes - Avoid last-minute regulatory bottlenecks by proactively adopting compliant technologies.
✔ Enhance Supply Chain Transparency - Ensure traceability, reducing counterfeit risks and improving patient safety.
Get Ahead of Compliance with Kevision
With the 16 February 2027 deadline, now is the perfect time to integrate Kevision's serialization and aggregation solutions into your production lines. Stay ahead of evolving regulations and ensure compliance with ease.

📞 Contact Kevision Today: 079-29605855
📍 Head Office: ST 101, One 42, B/H Ashok Vatika, Near Jayantilal Park BRTS, Ambli Bopal Road, Ahmedabad 380 054, Gujarat, India
www.kevision.in

As a leader in Track & Trace solutions, Kevision remains at the forefront of helping pharmaceutical companies meet evolving regulatory requirements seamlessly. With cutting-edge serialization and aggregation technologies, Kevision ensures compliance with AIFA's updated guidelines while optimizing packaging line efficiency.

This release was published on openPR.