Italy AIFA's New Guidelines for Pharmaceutical Packaging: Powered by Kevision's Expertise

The Italian Medicines Agency (AIFA) has recently issued a draft decree outlining updated regulatory guidelines for pharmaceutical packaging, aimed at aligning with the EU Falsified Medicines Directive (FMD). These changes, effective from 9 February 2025, represent a pivotal step in advancing drug safety, traceability, and compliance within Italy's pharmaceutical industry.
As a trusted leader in Track and Trace solutions, Kevision is committed to helping pharmaceutical manufacturers navigate these new requirements with ease and efficiency. Here's everything you need to know about the guidelines and how Kevision's cutting-edge technologies (https://kevision.in/kevsecure-l4/) can ensure compliance.

What Are the New Guidelines?
The updated AIFA guidelines apply to all pharmaceutical products and focus on enhancing traceability and authentication through the use of GS1 standards in both secondary and tertiary packaging. Kevision's serialization and aggregation systems are fully equipped to handle these requirements.
Secondary Packaging (e.g., cartons containing primary packs):
1. Barcode Symbology: GS1 Datamatrix.
2. Barcode Contents: GTIN, Expiry Date, Batch Number, and Serial Number.
3. Human-Readable Expiry Date Format: YYMMDD.
4. Barcode Data Encoding: Adherence to GS1 standards.
5. Serial Number Randomization: Not required.
Tertiary Packaging (e.g., shippers containing multiple secondary packs):
1. Barcode Symbology: GS1-128 linear.
2. Barcode Contents: Product code (GS1 GTIN optional), Lot Number, Expiration Date, and GS1 SSCC (Serialized Shipping Container Code).
3. Aggregation Data Capture: Parent-child mapping is not required.

Kevision's solutions(https://kevision.in/kevsecure-l4/) seamlessly integrate these requirements, enabling manufacturers to achieve compliance effortlessly.

Key Compliance Measures for Manufacturers with Kevision
Serialization Made Easy
With Kevision's advanced Track and Trace ecosystem, manufacturers can include required details-GTIN, Expiry Date, Batch Number, and Serial Number-in GS1 Datamatrix barcodes for secondary packaging and GS1-128 linear barcodes for tertiary packaging.
Effortless Data Exchange
Kevision ensures smooth data exchange to comply with AIFA's requirements:
1. Unit and Aggregation Data Sharing: Share data with third-party repositories or trading partners.
2. Export Registration: Register export shipments in the proposed repository, simplifying global compliance.
Authentication and Reporting Simplified
With Kevision's scalable solutions:
1. Downstream trading partners can authenticate shipments with ease.
2. Manufacturers can avoid complex government reporting mandates while staying ahead of future updates.

What Sets These Guidelines Apart?
AIFA's guidelines introduce a streamlined approach to serialization and traceability:
1. No need for serial number randomization or parent-child aggregation data capture.
2. Flexible barcode encoding and data exchange protocols.
3. Future-proofing through a centralized authentication data repository.
Kevision's innovative technologies are designed to adapt to these guidelines while ensuring scalability for evolving global standards.

Implications for the Pharmaceutical Industry
By adopting these regulations, Italy reinforces its commitment to preventing counterfeit drugs and ensuring consumer safety. Manufacturers can rely on Kevision's expertise to:
1. Make Operational Adjustments: Align packaging processes with GS1 standards.
2. Invest in Advanced Infrastructure: Upgrade serialization equipment, barcode printing, and data management tools.
3. Simplify Export Compliance: Use Kevision's systems to register export shipments in the data repository effortlessly.

How Kevision Helps You Prepare for Compliance by 2025
The transition to AIFA's guidelines requires precision, and Kevision's Track and Trace solutions provide a clear path to compliance. Here's how we can help:
1. System Assessment: Evaluate and upgrade your serialization and aggregation capabilities.
2. GS1 Standards Implementation: Ensure all barcode symbologies and data content meet AIFA's specifications.
3. Technology Integration: Leverage Kevision's seamless solutions for data exchange and reporting.
4. Expert Guidance: Partner with Kevision's team for smooth implementation and minimal disruption.

A Step Towards Safer Pharmaceuticals with Kevision
AIFA's new guidelines signify a brighter future for pharmaceutical safety, and Kevision is at the forefront of helping businesses transition smoothly. With these updates, manufacturers can enhance traceability, reduce counterfeiting risks, and build consumer trust while maintaining compliance with both national and EU standards.
As the compliance deadline of 9 February 2025 approaches, rely on Kevision's trusted Track and Trace solutions to ensure your business thrives in this era of enhanced pharmaceutical traceability.

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Protecting the Authenticity of Medicines and Products with Advanced Software and Systems
Since its inception, Kevision has been on a mission to develop software and systems to protect the authenticity of medicines and other products. In its first year, Kevision launched three modern technologies to provide Serialization and Camera-based inspection systems.

This release was published on openPR.