With the decree of 6 March 2025, the Italian Ministry of Health defined the technical specifications of the «Data Matrix» unique identifier for medicinal products for human use referred to in Delegated Regulation (EU) 2016/161, implementing Article 3(3) of Legislative Decree No. 10 of 6 February 2025.
Technical characteristics of the Data Matrix code
The optically readable code, called Data Matrix, applied by the manufacturer to the packaging of medicinal products for human use, is made up of the following information:
a) the «product code», which identifies at least the name, the common name, the pharmaceutical form, the strength, the pack size and the pack type of the medicinal product bearing the unique identifier;
b) the «serial number», a numeric or alphanumeric sequence of no more than 20 characters, generated by a deterministic or non-deterministic randomisation algorithm;
c) the «A.I.C. code», the number assigned by the Italian Medicines Agency with the marketing authorisation for Italy (A.I.C. stands for Autorizzazione all'Immissione in Commercio, the Italian marketing authorisation number);
d) the «batch number»;
e) the «expiry date».
The technical specifications of the Data Matrix are the following:
a) The product code is the Global Trade Item Number (or EAN code), hereinafter GTIN: a 14-digit numeric code built according to the GS1 System specifications and assigned by the manufacturer. The last digit of the GTIN is a check digit calculated with a specific algorithm;
b) The serial number is an alphanumeric code of at most 20 characters, generated by a randomisation algorithm and assigned by the manufacturer;
c) The A.I.C. code is made up of 9 digits, the first of which is zero and the last a check digit;
d) The batch number is an alphanumeric code of at most 20 characters, assigned by the manufacturer;
e) The expiry date is a 6-digit numeric code with the following structure: the first two digits are the year of expiry, the next two the month and the last two the day (YYMMDD).
Compared with the GS1 DataMatrix codes we discussed in a previous article, the Data Matrix codes for Italy contain an additional field holding the A.I.C. code already used to identify pharmaceutical products in Italy.
Data Matrix readers will therefore be able to identify packs of medicinal products not only by their GTIN but also by their A.I.C. code, in a fully transparent way.
Implementation timeline
Italy has postponed by two years the adoption of the Data Matrix, the European medicines traceability system based on a unique two-dimensional code printed on the pack in place of the adhesive sticker (bollino) of the Italian State Printing Office, which should have come into force on 9 February 2025.
The final version of the legislative decree approved by the Council of Ministers provides for a «stabilisation period» until 9 February 2027, allowing pharmaceutical companies to keep using the old adhesive sticker while they update their logistics flows and their reading and scanning systems, and freezing the penalties foreseen for violations.
Support for Data Matrix codes
The myHealthbox solution already supports GS1 DataMatrix codes as well as the Application Identifiers (AI) specific to the Italian market, so it can read both the old CODE-39 codes of the sticker used until now and the new Data Matrix codes.
The barcode reader already available in the myHealthbox search bar can be used to read both the old and the new codes.