Unique identification of trade items through the use of GTINs is critical to maintaining operational efficiencies that business partners rely on to exchange information about products in consistent ways, as well as ensuring the smooth operations of global supply chains. GTINs provides unique identification for Healthcare Items. When combined with other relevant information such as the item’s batch number and expiration date, it will provide traceability from production to patient delivery.
Please reference the GS1 Healthcare GTIN Allocation Rules for detailed information regarding compliance with GTIN standards that will meet the NHRA requirements. Barcodes are symbols that can be scanned electronically using laser or camera-based systems. Companies use them to encode information such as product numbers, serial numbers and batch numbers. Barcodes play a key role in pharmaceutical supply chains, enabling manufacturers, transport providers and hospitals to automatically identify and track products as they move through the supply chain.
The GS1 standards for barcoding of packages at the individual packaging level (GTIN) requires that both a 2D scannable label and information that can be read by a person, must be present. The Human readable version can carry the Application Identifier (AI), a field of two or more digits at the beginning of an element string that uniquely defines its format and meaning. All unit level barcoding must have the following attributes:
An identification key that uniquely identifies products worldwide. It can be encoded in various types of data carriers, including GS1 Data Matrix. A company receives a GS1 Company Prefix by joining a GS1 Member Organization. This gives the company the ability to create GTINs and access to the GS1 standards. You can refer to the GS1 General Specifications and GS1 Healthcare GTIN Allocation Rules for the GTIN Structure.
If you require additional data to identify an Expiration Date the GS1 Application Identifier (17) (often referred to as expiry date, use by date or maximum durability date) is used. It is expressed as year, month and day (YYMMDD).
Note: The Expiration Date data string can only specify dates within a certain range. Please refer to the GS1 General Specifications for additional information on structure and range.
If Healthcare products are to be individually tracked and traced using a Serial Number, Application Identifier (21) can be used. This additional data is alphanumeric with a variable length of up to 20 characters. The SN determined by the pharmaceutical company does not need for a third party to get the SN. The GS1 application identifier used to identify the SN is 21.
If you require additional data to identify Batch or Lot Number, the GS1 Application Identifier (10) is used and typically assigned at the point of manufacture. This additional data is alphanumeric with a variable length of up to 20 characters. Please note that the above attributes are not standalone attributes and must be associated with a GTIN and encoded within the same Data Carrier.
When the data format required to be displayed matches the HRI format, the AI may be used. However, when it does not match, the AI must be omitted, but the data label should be used to identify the attribute (refer to the GS1 General Specifications for more detail).
This applies to all encoded attributes that may appear on a healthcare product label. In the following examples, some data is shown in HRI, while other data is in non-HRI, When the non-HRI format is used, but the application identifier label, (17), is omitted. These label formats used in the examples are not intended to be descriptive or recommendations for meeting the requirements of the standards or local regulations.
If you are developing your artwork for packaging and still need to acquire your barcodes from GS1 you can find additional help for setting up your GS1 standard barcodes using 10-steps-to-barcode-your-product found in the GS1 library.
GS1 provides guidelines for aggregating from individual units to higher-level parent containers. For which there is a need to retrieve predefined information (i.e. master data) and that may be priced, or ordered, or invoiced at any point in any supply chain.
Established for transport and/or storage that needs to be managed through the supply chain. Logistics units take many forms (e.g., a single box containing a limited number of products, a pallet of multiple products or an intermodal container containing multiple pallets).
You can find additional information regarding labeling and barcodes on the GS1 Website: GS1 Standards in Barcoding.