Italy is currently completing the transition from its national bollino system to the full implementation of the EU Falsified Medicines Directive (FMD). The current stabilization period ends on February 8, 2027.
From February 9, 2027, medicinal products subject to serialization requirements and released for the Italian market will need to include:
— a 2D Data Matrix carrying the unique identifier
— a tamper-evident seal
— the required carta valori security support
The required elements must be integrated into the secondary packaging while preserving the visibility and readability of all mandatory product information. INEL can support you in preparing your packaging lines for these requirements. The necessary systems can be integrated into existing INEL PV-1300, PV-1800 or PV-2100 machines or supplied as custom solutions, depending on your current equipment and production needs.
If you are planning to supply affected medicinal products to the Italian market after February 2027, please feel free to contact us.
We would be happy to review your current setup and discuss the most suitable solution for your production line.
