Italy has made a significant step forward in combating pharmaceutical counterfeiting and enhancing supply chain transparency with the introduction of an advanced barcode system. Following Legislative Decree No. 10 of February 6, 2025, the country has implemented the EU Falsified Medicines Directive (FMD), aligning with European standards to safeguard patient safety.

Starting February 2025, all medicinal product packaging in Italy must feature a GS1 DataMatrix two-dimensional barcode. This code uniquely identifies each package by including five critical pieces of information:

• The Global Trade Item Number (GTIN) for product identification

• The serial number

• The batch or lot number

• The expiration date

• The Marketing Authorization Number (AIC) issued by the Italian Medicines Agency (AIFA)

These data points enable effective tracking and tracing of medicines throughout the supply chain, preventing counterfeit products from reaching patients and improving transparency in pharmaceutical logistics.

Italy, the last among EU countries alongside Greece to adopt this system, benefits from a two-year transitional period until February 2027. This timeframe allows pharmaceutical companies to fully implement all technical requirements while maintaining operational continuity.

The rollout was supported by a collaborative industry task force, coordinated by GS1 Italy, which comprises representatives from pharmaceutical companies and trade associations. Their joint efforts facilitated the evaluation and adoption of standardized serialization methods that enhance supply chain security and comply with EU regulations.

Bruno Aceto, CEO of GS1 Italy, highlighted the importance of this development: “Italian pharmaceutical companies will now use GS1 standards that uniquely identify products, improving traceability and the overall efficiency of the supply chain. This is a crucial step toward harmonizing Italy with Europe in the fight against counterfeit medicines.”

This regulatory advancement is expected to significantly reduce the risk of falsified drugs entering the market and to provide greater protection for patients across Italy.