The Medicine Verification System
Directive 2011/62/EU (also known as the “Falsified Medicines Directive”) defines a “Falsified Medicine” as any medicinal product with a false representation of:
- IDENTITY (confezionamento ed etichettatura, dosaggio)
- ORIGIN (manufacturer, Marketing Authorization Holder, country of origin)
- HISTORY (records and documents related to the distribution channels used)
Medicinal Products for Human Use with Data Matrix
The Delegated Regulation (UE) 2016/161 of the European Commission introduced a new system for the identification of medicinal products by requiring the placement of a unique, two-dimensional Data Matrix on the packaging of medicines for human use.
This Regulation, which supplements Directive 2001/83/EC of the European Parliament and of the Council, lays down detailed rules on the safety features appearing on the packaging of medicinal products for human use, and has been in force across Europe since 9 February 2019.
Italy, which already had a national system for the unique identification of medicines, was granted an extension until 2025. Subsequently, in implementation of the EU regulation, Legislative Decree No. 10 of 6 February 2025 was enacted.
Starting from 9 February 2025, the Regulation requires the application of two safety features on the packaging of prescription medicines:
- Unique identifier (Data Matrix)
- Anti-tampering device (ATD)
In the Italian context, a third element will also be applied:
- A security-featured support (carta valori) that could also become digital
From February 9th 2025 to February 9th 2027 , a transitional stabilization period is foreseen (Article 13, paragraphs 4 and 5 of Legislative Decree No. 10/2025), for the operations related to the application, activation, verification, and deactivation of the Data Matrix. During this period, manufacturers will still be allowed to market batches of medicines covered by the European regulation using the Italian pharmaceutical label ("bollino farmaceutico").
In addition, medicines already on the market with the Bollino label may be distributed and supplied to the public in Italy until their expiry date, without being repackaged or relabeled. For more information, please consult the dedicated page on the Ministry of Health website.
Medicines Subject to the Data Matrix
The new unique identification system applies to all prescription-only medicines, with the exception of certain specific categories listed in Annex I of Delegated Regulation (EU) 2016/161. It also includes a few non-prescription medicines considered at higher risk of falsification, listed in Annex II of the Regulation — currently, omeprazole 20 mg and 40 mg.
What information does the Data Matrix contain?
As regulated by the Ministry of Health Decree of March 6, 2025,the Data Matrix code is composed of five essential elements:
- 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.
- Serial Number
- A numeric or alphanumeric sequence (up to 20 characters).
- Randomly generated by the manufacturer through a randomization algorithm.
- AIC Code (Marketing Authorization Number)
- A 9-digit number assigned by the Italian Medicines Agency (AIFA) for authorization to market in Italy.
- Batch Number
- An alphanumeric code (up to 20 characters) that identifies the production batch of the medicine.
- Expiration Date
- Indicated with 6 digits in the format YYMMDD (Year, Month, Day).
How is the Data Matrix code printed?
- It must be printed directly on the medicine packaging, on a smooth, uniform, and non-reflective surface.
- In the case of medicines without external packaging, the code is printed directly on the primary packaging.
- Products without the code or non-compliant codes cannot be placed on the distribution channel.
Technical Standards of the Data Matrix
The Data Matrix code follows international technical specifications to ensure readability and interoperability:
- Symbology: GS1 Data Matrix (ECC 200 variant) – ISO/IEC 16022:2006 Standard..
- Reference standard: GS1 system, with data structure defined by the GS1 technical specifications manual..
- Data structure (Application Identifier – AI):
- 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)
Human Readable Interpretation (HRI)
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).
Example representation of the Data Matrix code
The Data Matrix code can be represented through a data string according to GS1 Application Identifiers. An example of an encoded string could be:
]d201080320890012362101234567890<GS>1727103010112345678<GS>716098765432
Where
- ]d2 → Identifies the GS1 Data Matrix
- 01 08032089001236 → Product Code (GTIN)
- 21 01234567890 → Serial Number
- 17 271030 → Expiration date (October 27, 2030)
- 10 112345678 → Batch Number
- 716 098765432 → AIC code
The GS character is a separator that indicates the end of a variable-length field.
Regarding the type of Anti-tampering device (ATD):
The device that allows verification of whether the medicine packaging has been tampered with, drug manufacturers will have the option to choose the type among those authorized for the EU market.
