2025 Drug serialisation in Italy
What do you know about it?
Starting from February 9, 2025, Italy will implement the pharmaceutical serialization system mandated by the European Falsified Medicines Directive (FMD). This marks a significant shift for the pharmaceutical industry, introducing new regulations to enhance patient safety and packaging integrity.
What’s changing?
- Introduction of a unique identifier for every Rx medicine package to ensure authenticity and traceability
- Mandatory anti-tampering device (ATD), even for medicines without prescription
- Additional “security-supported device“, required for only Rx medicines
- A 24-month transition period to ensure a smooth and uninterrupted operational shif
These measures will have a significant impact on manufacturers, distributors, and pharmacies, requiring adjustments to processes, data management, and IT systems.
For more information, download the full report
For further information, please contact:
Antonio FOIS
Francesca TONI