Regulatory Background
- The Falsified Medicines Directive (2011/62/EU) aims to combat counterfeit medicines by protecting the integrity of the pharmaceutical supply chain.
- A falsified medicine is one that misrepresents its:
- Identity (packaging, labeling, dosage)
- Origin (manufacturer, MAH, country of origin)
- History (distribution records and supply chain documentation)
Legal Framework
- Delegated Regulation (EU) 2016/161 introduced mandatory safety features for medicinal products across the EU.
- While most EU countries implemented the regulation on 9 February 2019, Italy received a derogation due to its existing national pharmaceutical labeling system (Bollino).
- Italy implemented the EU requirements through Legislative Decree No. 10/2025.
Transition Period
- 9 February 2025 – 9 February 2027
- Manufacturers may continue placing medicines on the Italian market using the existing Bollino system during the transition.
- Products already on the market with the Bollino can continue to be distributed until their expiry date.
Required Safety Features
Prescription medicines in Italy must include:
- GS1 DataMatrix (Unique Identifier)
- Anti-Tampering Device (ATD)
- Security-featured support (Carta Valori), an additional Italian requirement that may become digital in the future.
Products Covered
- All prescription-only medicines, except those exempted in Annex I of Delegated Regulation (EU) 2016/161.
- Certain higher-risk non-prescription medicines, currently including:
- Omeprazole 20 mg
- Omeprazole 40 mg
Data Encoded in the GS1 DataMatrix
The Data Matrix contains five mandatory data elements:
- GTIN (AI 01) – Product identifier
- Serial Number (AI 21) – Randomized unique serial number
- Batch/Lot Number (AI 10)
- Expiry Date (AI 17) – Format YYMMDD
- AIC Code (AI 716) – Italian Marketing Authorization Number
Technical Standard
- Barcode type: GS1 DataMatrix (ECC200)
- GS1 Application Identifiers:
- (01) GTIN
- (21) Serial Number
- (10) Batch Number
- (17) Expiry Date
- (716) AIC Code
Human Readable Information (HRI)
The following information must also appear in text near the Data Matrix:
- Product Code (GTIN)
- Serial Number
- Batch Number
- Expiry Date
- AIC Number
Example representation of data matrix code
]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.
Printing Requirements
- The GS1 DataMatrix must be printed directly on the outer packaging.
- If no outer packaging exists, it must be printed on the primary packaging.
- Products without a compliant Data Matrix cannot be placed on the market.
Anti-Tampering Device (ATD)
- Every applicable medicine package must include an Anti-Tampering Device that enables verification of whether the package has been opened or tampered with.
- Manufacturers may choose any ATD that is approved for use within the European Union.
Key Takeaways
- Implementation: 9 February 2025 with a transition period until 9 February 2027.
- Safety Features: GS1 DataMatrix + Anti-Tampering Device + Italy's additional Carta Valori.
- DataMatrix Contents: GTIN, Serial Number, Batch Number, Expiry Date, and AIC Code.
- Standard: GS1 DataMatrix (ECC200) using GS1 Application Identifiers (01), (21), (10), (17), and (716).