From Bollino to GS1: Italy's Crucial Shift for EU FMD
The European Falsified Medicines Directive (FMD) Explained
On February 9, 2025, Italy is expected to fully integrate into the European Falsified Medicines Directive (FMD) legislation. This integration marks the culmination of a compliance journey that began with the establishment of the National Medicines Verification Organization (NMVO Italy) on January 17, 2024. The NMVO Italy was formed to prepare the pharmaceutical sector for the Italian implementation of Directive (EU) 2011/62 and Delegated Regulation (EU) 2016/161, which focus on preventing medicine counterfeiting.
The introduction of the European framework on medicine traceability and anti-counterfeiting will bring significant changes to Italy’s pharmaceutical packaging and distribution systems, replacing the current electronic vignette system with GS1 standards. This transition is crucial for aligning with the broader EU FMD, which has been in effect since February 9, 2019, and mandates safety features for pharmaceutical products to protect public health and enhance patient safety across Europe.
As Italy navigates this transition, the NMVO, alongside key industry players, will play a pivotal role in monitoring legislative developments and supporting institutional discussions. The EU FMD requires healthcare supply chain stakeholders to implement complex systems and IT infrastructure to comply with the directive. However, with the availability of specialized solutions like our proprietary out-of-the-box Movilitas.Cloud solution, this transition can be managed effectively, ensuring that Italy’s healthcare supply chain meets the safety standards set by the EU.
The Impact of the EU FMD on Wholesalers & Distributors
The pharmaceutical supply chain is complex in nature, but in essence, there are key stakeholders that are required to share data to support serial number authentication and traceability. For wholesalers and distributors, the obligation is to secure the supply chain and verify any suspicion of falsified medicines. Primary wholesalers that buy from the original manufacturer or Marketing Authorization Holder (MAH) do not need to perform risk-based verification given the product will come from a trusted source. Secondary wholesalers that buy products off the market or from other wholesalers must complete risk-based verification. Those that sell 'out of market', such as to universities for research, must decommission serial numbers. Ultimately, distributors must complete risk-based verification for saleable returns prior to reselling the product, regardless of the product source.
Italy’s Challenges in Meeting EU FMD Compliance
- System Transitions: Italy needs to replace the Bollino system with GS1 standards, which involves complex changes to packaging and circulation.
- IT Upgrades: Compliance demands significant IT system and infrastructure upgrades, which can be costly and complex.
- Data Migration: Transitioning label data from Bollino to GS1 standards requires accurate and careful management to avoid disruptions.
- Training: Effective implementation relies on educating and training all supply chain stakeholders about new requirements.
- Costs: The transition involves significant expenses for system upgrades, process changes and training, posing challenges, especially for smaller stakeholders.
- Market Readiness: Preparing the market to understand the importance of using a reputable traceability system is essential for successful implementation.
Movilitas.Cloud: Addressing Challenges with Ease Across the Pharmaceutical Value Chain
Movilitas.Cloud is a next-generation Software-as-a-Service cloud-based platform. Developed by Engineering Industries eXcellence, the tool helps industrial enterprises digitally serialize, track and trace products worldwide across supply chain networks while ensuring compliance with applicable regulations and industry-specific standards. With Movilitas.Cloud, companies can onboard suppliers, distributors and partners to create a seamlessly connected global supply chain network that drives product safety and authenticity for your end customers.
Serialized Logistics
Logistics involves the storage and movement of goods between different points in the supply chain, coordinating facilities, people, equipment and other resources to ensure products move when they are supposed to and there is space for them at the next stop. When serialization is applied to the logistic process, its primary focus is the delivery of products to end consumers and the decommissioning of serial numbers at the end of the product lifecycle. Most ERP and WMS solutions are not capable of managing serialized logistics on their own, and if this complicated process is mishandled, it can negatively impact business processes across the entire supply chain. Our Serialized Logistics solution within Movilitas.Cloud enables stakeholders across the supply chain to reduce the complexity of this process, providing effective management of inbound and outbound goods, re-aggregation and SSCC re-labeling.
Key Benefits
- Improved product safety and quality
- Ensured compliance with government and industry regulations
- Preventative counterfeiting and associated costs
- Ensured product authenticity and quality
- Protected supply chain integrity
- Protected brand reputation and customer service levels
- Enabled end-to-end visibility of manufacturing and supply chain
- Reduced manufacturing and logistic complexities
Engineering’s FMD & Movilitas.Cloud Solution Expertise
As regulations for serialization and demands for product traceability grow, so will the value of integrated technologies for tracking and tracing. The strong technical expertise, profound industry knowledge and successful delivery record of our Track & Trace specialists makes Engineering Industries eXcellence a power player in the arena of serialized manufacturing and logistics. Within the Engineering Industries eXcellence technology portfolio for Digital Supply Chain, Movilitas.Cloud is our proprietary Software-as-a-Service solution that makes serialization and compliance simple and efficient. With multilingual capabilities and a global team providing ongoing support, we continuously strive to fulfill our mission of helping companies meet the demands of today's dynamic economy with a quick step-by-step approach.
