Revolution in Italian Pharmaceutical Serialization: Farewell to the Bollino, Welcome Datamatrix

The Future of Drug Traceability: Towards a New Standard with Datamatrix

The Italian pharmaceutical sector is preparing for a major change with the implementation of the European Directive FMD 2011/62/EU. This directive will lead to:

1. Eliminating the pharmaceutical tracking system based on the bollino in favor of adopting the more modern and efficient Datamatrix system;
2. The introduction of the Tamper Evident.

Farewell to the Bollino

The bollino (pharmaceutical security label), a well-known tool for identifying drug packages in Italy, is about to be "retired." This change is driven by the need to comply with new European pharmaceutical traceability standards. Although reliable, the bollino has shown limitations in the digital era, pushing the industry towards a more advanced solution.

The European Directive FMD 2011/62/EU aims to protect patients from the risks posed by counterfeit drugs and is already in force in the rest of Europe. Its application is also necessary for all drugs intended for the Italian market and requires the adoption of more modern and secure technologies, such as Datamatrix.

The Advantage of Datamatrix in Pharmaceuticals

Datamatrix represents the most widespread technology for pharmaceutical serialization. It is a two-dimensional code (2D Barcode) that can contain and convey information such as GTIN, Serial Number, Expiration Date, and Lot Information. The Datamatrix-based system is designed to improve the traceability of drugs throughout the entire distribution chain.

With this new system, pharmaceutical companies can ensure greater safety and compliance with European regulations. The technology allows for the rapid and precise identification of each individual product unit, facilitating the management of prescriptions and reimbursements.

European Directive FMD 2011/62/EU and Drug Coding

The European Directive FMD 2011/62/EU requires:

• The coding of mandatory data relating to individual packages placed on the market (including the serial number), and
• Transmitting this data from MAH to the European Hub (EMVS) and from them to national platforms NMVS to ensure the unicity of the serial numbers and, therefore, the authenticity of the products.

Drug coding through Datamatrix allows critical drug information to be integrated into a digitalized and easily accessible format. This not only helps combat counterfeiting but also simplifies inventory and distribution management operations, with advantages far superior to those of the system in use today.

The system also mandates anti-tampering packaging techniques, or anti-tampering devices, which ensure the integrity of the supply chain up to the final patient.

Antares Vision Group: Leading the Implementation of Datamatrix

Antares Vision Group, a global leader in pharmaceutical traceability solutions, is a key player in this transformation.

The company offers a comprehensive ecosystem of software and hardware solutions to enable companies to comply with the European Directive FMD 2011/62/EU and adopt Datamatrix as the standard for pharmaceutical serialization.

Gianfranco Landolfi, Life Science General Manager of Antares Vision Group, emphasizes the importance of this transition: “The safety of medicines will be further enhanced with the introduction of the new regulation, which provides for both digital and physical features for pharmaceutical product packaging. We are ready to support companies in adapting to these requirements, offering software and hardware solutions to ensure full compliance with the FMD regulation, and software solutions from L4 to L1, capable of managing each production line's needs, up to the communication with the European Hub (EMVS).”

Ongoing Discussions and Future Adaptations

As the industry transitions to the new directive, two key issues remain unresolved:

1. Addition of a Fifth Line for AIC Code: There is ongoing debate about the potential requirement to include a fifth line containing the AIC code. This addition could pose challenges for existing lines that may struggle to print five lines without compromising efficiency or may not be capable of printing five lines at all.
2. Scope of Drug Monitoring: The current Bollino system covers a wider range of drugs compared to the European Datamatrix. While the FMD 2011/62/EU regulation mandates serialization for prescription drugs, the Bollino also includes OTC and SOP drugs, leading to a discrepancy in the scope of drug monitoring.

Given these ongoing discussions, Antares Vision Group remains vigilant and responsive to changes or new requirements. Let's connect: our team is equipped to meet any needs that arise, ensuring our clients are always compliant and efficient, regardless of the evolving regulatory landscape.

Stay informed and prepared for the future of pharmaceutical serialization with Antares Vision Group!

Contact us to get more info.