Italy is embarking on a significant shift in its pharmaceutical regulation by transitioning from the Bollino system to the European Union’s Falsified Medicines Directive (EU FMD) by February 9, 2025. This change aims to strengthen patient safety, combat counterfeit medicines, and align Italy with EU-wide standards. However, for pharmaceutical manufacturers, this transition presents both challenges and opportunities. Below, we explore the key challenges and provide a step-by-step guide to help companies prepare for the shift.
Key Challenges for Pharmaceutical Manufacturers
System Transition
The move from the Bollino system to EU FMD-compliant GS1 standards requires significant changes to packaging and distribution processes. Manufacturers need to adopt new serialization and digital tracking protocols, which are more complex than the traditional Bollino system.
IT Infrastructure Upgrades
Compliance with EU FMD demands substantial upgrades to IT systems and infrastructure. This includes integrating software capable of managing serialization data and connecting to the European Medicines Verification System (EMVS).
Data Migration
Transitioning from Bollino labels to GS1 standards involves migrating data accurately. This process can be prone to errors if not managed carefully, potentially disrupting supply chains.
Regulatory Compliance
Understanding and implementing the EU FMD’s stringent requirements for product serialization, digital tracking, and data sharing with the centralized EU hub is complex and time-consuming.
Financial Investment
The transition involves significant costs, including purchasing serialization equipment, implementing software, annual license fees, and ongoing maintenance. Small and medium-sized enterprises may find these expenses particularly challenging.
Step-by-Step Guide to Preparing for the Transition
Early Awareness and Planning
Begin preparations well in advance. Recognize the scope of the transition and allocate sufficient time for product review, process adjustments, and artwork modifications for new labeling requirements.
Assess Current Systems
Conduct a thorough evaluation of your existing packaging, labeling, and IT systems. Identify gaps and determine the upgrades or replacements needed to meet EU FMD standards.
Develop a Transition Strategy
Create a detailed plan that outlines the necessary steps, timelines, and resources. Assign clear responsibilities to stakeholders to ensure a coordinated effort.
Invest in Technology
Acquire and implement the required serialization hardware and software. Ensure that these systems are validated and compliant with EU regulations.
Staff Training
Train your workforce on the new processes and systems. Employees should understand the importance of compliance and be equipped to manage serialization and data tracking efficiently.
Data Management
Establish robust data management protocols to ensure accurate migration and ongoing integrity of serialization data. Use centralized systems to streamline operations and improve traceability.
Engage with Regulatory Bodies
Maintain regular communication with relevant authorities and industry bodies. Stay informed about regulatory updates and seek guidance to address specific compliance concerns.
Continuous Monitoring and Improvement
After implementing the new system, continuously monitor its performance. Identify areas for improvement and ensure ongoing compliance with EU FMD requirements.
Conclusion
The transition from Bollino to EU FMD is a monumental step for Italy’s pharmaceutical industry. While the process poses challenges, proactive planning and a structured approach can help manufacturers navigate the change effectively. By aligning with EU FMD standards, Italy’s pharmaceutical supply chain will achieve greater safety, transparency, and efficiency, ultimately benefiting patients and stakeholders alike.
References
Securing Industry: [Three Dates for Your EU FMD 2025 Calendar] (https://www.securingindustry.com/pharmaceuticals/three-dates-for-your-eu-fmd-2025-calendar/s40/a15778/)
INDX: [Italy's Switch to EU FMD: Challenges and Opportunities] (https://www.indx.com/en/posts/italys-switch-to-eu-fmd-challenges-and-opportunities-from-an-expert-perspective)
Prespack: [Serialization Enters the Italian Market] (https://prespack.pl/en/46-blog/351-serialization-enters-the-italian-market-what-challenges-await-companies-due-to-these-changes)
