The annual update to the GS1 General Specifications has arrived and there are some healthcare-related changes.
Patient safety is a central concern in healthcare. One way the pharmaceutical industry supports this is by providing patient information (PI) for each product. This is normally done by inserting printed information leaflets into each pack of medicine. However, a digital revolution is underway, providing PI electronically via mobile devices and the Internet. GS1's Digital Link specification supports a comprehensive PI mechanism that addresses a range of regulatory concerns including versioning, language selection, regulatory context, etc.
Digital Links supersede a GS1 application (8200) for extended packaging. 8200 encodes a base URL which, when combined with a GTIN, provides an address for additional information about a trade item. 8200 can be used in healthcare to provide electronic patient information leaflets (ePILs) or product characteristics summaries (SmPC). However, it is rarely used for these purposes. Digital Links provide a far more flexible approach.
GS1 now specifies that 8200 shall not be used for healthcare applications after 31st December 2026. At the same time, GS1 has removed a restriction on the choice of carrier for regulated healthcare consumer trade items. Previously, 8200 could only be encoded in Data Matrix barcodes for healthcare products but they can now be carried in QR codes. The motivation for this change is to remove any indication that 8200 should be used in healthcare applications. The message is clear. Don’t use 8200 for ePILs!
The retail world is rapidly moving towards much wider adoption of 2D barcodes at the point of sale (POS). GS1 mandates the use of linear barcodes for high-volume omnidirectional scanning at the POS. However, as technology improves, this restriction is no longer necessary. GS1 is preparing for the transition to 2D barcodes.
2D barcodes are mandated for regulated healthcare products in many regions. For example, the EU requires 2D barcodes to be scanned at the point of dispense (effectively the pharmaceutical POS). 2D barcodes contain more data and are more reliable than linear barcodes and are ideal for identification and verification purposes.
GS1 has updated their specifications, removing some outdated statements that conflict with real-world healthcare practices. In addition, GS1 has refined its language, emphasising its recommended use of Data Matrix barcodes, rather than QR codes, in regulated healthcare scenarios.
There are other textual improvements related to healthcare scenarios, including rephrasing, and an improved example of Service Relation Instance Numbers in clinical settings.
GMNs identify product models or product families. In healthcare, they are used to meet EU regulations by encoding Basic UDI-DI (BUD-DI) identifiers for medical devices. BUDI-DIs are an EU-specific concept that extends the IMDRF UDI system. Each BUDI-DI is a key value in the European database on medical devices (EUDAMED) , grouping together all information about related medical devices. Each unique product within a single BUDI-DI shares the same intended purpose, risk class, essential design, manufacturing characteristics and certification. GS1 does not allow GMN BUDI-DIs to be used in the physical marking or labelling of medical devices.
GS1 has updated its definition of the GMN. This doesn't introduce any change in its use but clarifies the relationship between GMNs and GTINs.
Many medicines are temperature sensitive. Pharmaceutical good distribution practice (GDP) requires end-to-end continuous monitoring of temperature for these products, both in transit and in storage, to ensure that medicines remain potent and safe. GS1 has added new applications (4330-4333), allowing minimum and maximum allowed temperatures to be stated on logistic labels for transport and storage. This supports GS1’s ‘Scan4Transport’ initiative which provides standards for encoding transport data on logistics labels. These new applications may be used widely to support GDP across the pharmaceutical supply chain.
Lastly, I will mention the inclusion of a new application (8030) for Digital Signatures, in conformance with ISO/IEC 20248. When I first saw this, I wondered if it was somehow related to the inclusion of digital signatures in Russian barcodes, used on a variety of trade items including medicines. However, the specification states that the new AI shall not be used in any labelling, physical marking or AIDC carrier (barcode) on regulated healthcare trade items.
In summary, the 2024 changes mirror growing trends in healthcare scenarios, further reinforcing GS1’s advocacy of 2D Data Matrix barcodes in regulated healthcare scenarios and the use of GS1 Digital Links.
All relevant changes to the GS1 General Specifications are reflected in the latest release of the Solidsoft Reply
GS1 validating parser, available on GitHub or as a Nuget package.
If you want to delve into more detail on the specification, the document can be downloaded
Solidsoft Reply is a committed GS1 partner and global award-winning Microsoft AI Cloud Solutions Partner with over a decade of experience in the verification of medicinal products using 2D barcode technology. As well as our cloud-based verification and traceability systems, we operate Digital Link resolvers and work with stakeholder organisations at national and global levels to ensure the safe supply of medicines to patients. Visit