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Medicines tracking: need for Italy to comply by February 9, 2025

The enabling decree law on medicine tracking is currently being discussed in the Senate; however, the timeframe for compliance is really tight, in fact by February 9, 2025, Italy will have to comply with EU Delegated Regulation 2016/161 (henceforth the “Regulation”). Together with Greece, Italy is the only country that has not yet aligned with the medicine tracking system regulated by the Regulation, enjoying a six-year extension compared to the entry into force in other countries in 2019.

The “Data Matrix,” a unique, two-dimensional identification code, was introduced by European Directive 2011/62/EU better known as the Falsified Medicines Directive (FMD). The FMD requires the use of Unique Identifiers (UIs) and Anti-Tampering Devices (ADTs) for all medicines deemed to be at risk of counterfeiting. UI and ADT are called safety features.

The UI contains 4 pieces of data in a 2D Data Matrix code and in readable characters: product code; serial number; lot number; expiration date.

Data coming in from safety features are managed by a European Hub, EMVS (European Medicines Verification System) and national repositories, NMVS (National Medicines Verification System), a system already adopted by other European countries.

Considering that 49 billion of Italy’s 50 billion pharmaceutical products are for export, industries in the sector are already ready for serialization.

Since no further extensions will be granted, Farmindustria, in collaboration with the Ministry of Health and the Ministry of Economy and Finance, has set up a consortium company to manage serialization in Italy: the NMVO Italia Scrl (National Medicines Verification Organization), as in other European countries.

We are confident that compliance with the Regulation will have positive impacts both from an environmental point of view and for consumers, who can be assured that the medicine purchased is not the result of counterfeiting.

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