INDUSTRIES, LIFE SCIENCES | Italian Council of Ministers approves the “European Tracking” Legislative Decree

On 7 February 2025, the Legislative Decree No. 10 of 6 February 2025 on “European Tracking” (Tracciatura Europea) was published in the Official Gazette, adapting national legislation to the European provisions on the safety features appearing on the packaging of medicinal products for human use (the Decree). The Decree, in accordance with Delegated Regulation (EU) No. 2016/161 (the Regulation), entails significant changes for the entire drug distribution chain by introducing a new drug traceability system, replacing the previous one. The Regulation leads to a substantial change not only for pharmaceutical companies but also for pharmacists, whose daily activities are now integrated with the verification of the integrity and originality of packaging, with consequent adaptation also at the technological level. It is a momentous change, which requires an initially unforeseen settling-in period, but if it had not been introduced it would have had serious consequences also in terms of continuity in the production and supply of drugs.

As is known, Italy already had a medicine tracking system in use, known as pharmaceutical stickers (introduced by Legislative Decree No. 540/1992) and for this reason had benefited from the postponement of the implementation of the Regulation from 2019 to 2025. However, given that in adapting to the Regulation at a national level, the legislator, in addition to the so-called datamatrix and the so-called anti-tampering, has provided for an additional element not contemplated by the Euro-unitary standards (i.e.: a device realized on a security support provided by I.P.Z.S. that can assume the characteristics of digital security paper), the sector has raised the alarm about the unreasonably restricted time period given for the predisposition of the required measures and compliance. For this reason, the legislator, with the Decree, has granted a so-called period of stabilization (period di stabilizzazione) of two years (i.e. until February 8, 2027), during which the qualified person (QP) will be able to release batches of medicines destined for the Italian market that only bear the current sticker.

This is a system that will rewuire a lengthy and costly adaptation phase, but one that will hopefully bring numerous benefits in terms of fighting the entry of counterfeit drugs into the territory, leading to advantages not only for companies, but also for patients.

Newsletter n. 104 – February 2025