In Italy, Legislative Decree no. 10 of 6 February 2025 was issued to implement EU legislation.
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)
A transitional stabilization period, from February 9, 2025, to February 9, 2027, is foreseen for the affixing, activation, verification, and deactivation of the Data Matrix. During this period, manufacturers will be able to continue marketing batches of medicinal products subject to European regulations with the pharmaceutical label.
The National Medicines Verification System (NMVS)
The Italian National Medicines Verification System responds to the need for a medicine verification system to ensure that drugs placed on the market are authentic and safe for patients.
The new medicine identification system provides for the verification of the authenticity of a medicine by reading the unique identifier and comparing it with the identifier data recorded in the National Archive .
When the medicine is dispensed, the unique identification code is "deactivated" to avoid its duplicate use.
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?
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).
Technical Standards of the Data Matrix
- 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
Pilot Project Purpose
The pilot is a real-life end-to-end validation of the system across the full supply chain.
Core objectives:
- Test serialization + verification flows step-by-step
- Identify operational gaps before national rollout
- Capture missing or unclear use cases
- Avoid failures seen in other EU countries
- Validate:
- System performance
- Speed & reliability
- Integration with national systems (STS)
Timeline
- Jan 2026 → Apr 2026
- Phase 1 uses:
- Non-sellable medicines
- Dispensing is simulated
Only test environments connected
Participants
Manufacturers (examples)
Pfizer, Sanofi, Teva, Viatris, Zentiva, Menarini, etc.
Logistics Providers
DHL, UPS Healthcare, Kuehne+Nagel
Wholesalers
Alliance Healthcare, Comifar, Unifarma, etc.
Pharmacies
- Selected for diversity:
- Urban / rural
- Public / private
- Different software systems
NGOs
Banco Farmaceutico Foundation
Medicines in Scope
- Real products (GMP compliant)
- Not for sale
- Selection criteria:
- No shortages
- Not high-cost
- Not hospital-only
- Multiple dosage forms