FAQs answered for you.

As regulated by the Ministry of Health Decree of March 6, 2025,the Data Matrix code is composed of five essential elements:

1. Product Code (GTIN – Global Trade Item Number)

• A 14-digit number that identifies the medicine, including the name, pharmaceutical form, dosage, and packaging type.
• Constructed according to the GS1 system specifications.

1. Serial Number

• A numeric or alphanumeric sequence (up to 20 characters).
• Randomly generated by the manufacturer through a randomization algorithm.

1. AIC Code (Marketing Authorization Number)

• A 9-digit number assigned by the Italian Medicines Agency (AIFA) for authorization to market in Italy.

1. Batch Number

• An alphanumeric code (up to 20 characters) that identifies the production batch of the medicine.

1. Expiration Date

• Indicated with 6 digits in the format YYMMDD (Year, Month, Day).
• 01 → GTIN (14 digits)
• 21 → Serial number (up to 20 characters)
• 10 → Batch number (up to 20 characters)
• 17 → Expiration date (YYMMDD)
• 716 → AIC code (9 digits)

To facilitate manual verification in case of optical reading problems, the key information of the Data Matrix code is printed in textual format on the packaging:

• PC → Product Code (GTIN)
• SN → Serial Number
• LOTTO → Batch Number
• SCAD → Expiration Date
• AIC → National reimbursement number

These pieces of information are preferably positioned near the two-dimensional barcode to facilitate reading.

The HRI information must be printed as indicated in the “Data Matrix” Decree (Ministry of Health Decree of March 6, 2025, Annex A – point 6).