The Ministry of Health defined the technical specifications for the Data Matrix code in the decree of 6 March 2025, which is the unique identification for medicinal products intended for human use. The measure implements the provisions of art. 3, co. 3 of Legislative Decree 10/2025, being part of the broader European framework outlined by Delegated Regulation (EU) 2016/161. The aim is to strengthen the traceability, authenticity and safety of medicines throughout the distribution chain.

As outlined in the article 1 of the decree, the Data Matrix in a two-dimensional, optically readable code, mandatory for most medicinal products, with the exception of those listed in Annex I of the EU regulation. It must comply with the requirements of Article 4 of Regulation (EU) 2016/161 and must to be applied by manufacturers, marketing authorization holders (M.A. holders), and all parties required under current legislation. Compliance must occur within the stabilization period established by Legislative Decree No. 10 of February 6, 2025.

Article 2 clarifies that the identification code of the medicinal product must be the same as M.A., which is assigned by the AIFA at the time of marketing authorisation in the national territory.

The information content of the Data Matrix is defined in Article 3. The code must contain five mandatory data elements: the product code (GTIN), the serial number, the M.A.-code, the manufacturing batch number and the expiry date. These data must be coded according to the specifications contained in Annex A of the decree.

The implementation of this decree does not entail any new or additional burdens on public finances, and the provisions came into force on the date of publication in the official gazette, i.e. april 10, 2025.

Annex A provides a detailed overview of the technical features of the code. The GTIN is a 14-digit numeric code. The code must comply with specific international standards: GS1 Data Matrix (ECC 200) symbology, according ti ISO/IEC 16022:2006, and GS1 Application identifier (AI) syntax, in accordance with ISO/IEC 15418:2009.

As for graphic requirements, the code must be printed on a smooth, uniform, and low-reflectivity surface.

The introduction of these new technical specifications marks a decisive step toward strengthening safety and transparency mechanisms in the distribution of medical products. Harmonization with EU standards will enable more effective control over every stage of the supply chain, helping to combat counterfeiting and more effectively safeguard public health.