Medicine Traceability: Italy Required to Comply by 9 February 2025

The delegated decree-law on medicine traceability is currently under discussion in the Senate; however, the timeframe for compliance is particularly tight. By 9 February 2025, Italy will have to comply with Commission Delegated Regulation (EU) 2016/161 (hereinafter, the “Regulation”). Together with Greece, Italy is the only country that has not yet aligned with the medicine traceability system governed by the Regulation, having benefited from a six-year extension compared with its entry into force in the other countries in 2019.

The “Data Matrix”, a unique two-dimensional identifier code, was introduced by European Directive 2011/62/EU, better known as the Falsified Medicines Directive (FMD). The FMD provides for the use of unique identifiers (UI) and anti-tampering devices (ATD) for all medicines considered at risk of falsification. UIs and ATDs are referred to as safety features.

The UI contains four data elements in a 2D Data Matrix code and in human-readable characters: product code, serial number, batch number and expiry date.

The data generated by the safety features are managed through a European hub, the EMVS (European Medicines Verification System), and through national repositories known as NMVSs (National Medicines Verification Systems), a system already adopted by the other European countries.

Considering that 49 out of 50 billion Italian pharmaceutical products are intended for export, companies in the sector are already prepared for serialisation.

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

We are confident that compliance with the Regulation will have positive effects both from an environmental perspective and for consumers, who will be able to be certain that the medicine they purchase is not counterfeit.