Why correct GTIN and 2D Code Data are important

The Defective Medicines Report Centre (DMRC) of the MHRA recently reported an increase in artwork errors, specifically relating to the Global Trade Item Number (GTIN) and the 2D GSI DataMatrix code, which encodes the GTIN, batch number, and expiry date of a drug product.  

Examples of reported issues include the following:

• GTINs that scan as a different medicinal product, compared to the physical product's name and details
• Incorrect data formats that cause robotic systems to reject valid stock
• Unreadable or missing 2D codes, that render products unscannable and unusable
• Uncontrolled GTIN reuse across different products, which leads to product confusion in existing systems.

These errors often result in stock being quarantined or completely discarded, or in the need for untimely manual workarounds that reintroduce human error into the system.

According to the agency, the Marketing Authorization Holder (MAH) is responsible for ensuring that the artwork and encoded data on a medicinal product are accurate, compliant, and aligned with regulatory and operational standards. While the MHRA recognizes that there is currently limited legislation regarding the standardization of this data, all patient safety risks must be mitigated as effectively as possible. The MAH should particularly ensure the accurate encoding of the batch number and expiration date in the 2D code, validate the artwork and code functionality during the artwork approval process, and avoid reusing GTINs that have already been used for other products.   

For more information, please see the MHRA Insepctorate Blog on the importance of accurate GTIN and 2D code data.