In this example the original GTIN may be used. After a 10-year absence from the market, “Product A” was reintroduced by the manufacturer, in its original form and package configuration, to treat infections resistant to newer antibiotics. Healthcare companies must ensure that GTINs allocated to regulated healthcare trade items SHALL never be reused.Įxception: Regulated healthcare trade items that have been withdrawn from the market and are reintroduced may use the original GTIN if they are reintroduced without any modifications or changes which require a new GTIN as specified by the Healthcare GTIN Allocation Rules or the GTIN Management Standard.Īs an example: “Product A”, a first-generation injectable antibiotic, was withdrawn from the market by its manufacturer due to declining sales. ■ Product change: An existing product, currently in the brand owner's portfolio and available in the marketplace whose attributes have been changed.Īn allocated GTIN SHALL NOT be reallocated to another trade item. ■ New product: A "new product" is defined as a product that does not currently exist or has not been available for sale and is an addition to the brand owner's portfolio/is new to the marketplace.
The Healthcare GTIN Allocation Rules define that a new GTIN is required when a change to certain attributes of an existing product change such that a new GTIN is required. GS1 standards and the Healthcare GTIN Allocation Rules require that if a product is new, it should always be assigned a new GTIN to accurately distinguish the new product from those currently available in the marketplace or previously existing product that has been discontinued.Ĭhanges to existing products are considered “replacement product” as determined by the brand owner. A new product should be considered an “addition” to an existing product offering.
New products are those which do not currently exist in a brand owner’s product offering and are new to the marketplace. When making decisions about product identification, it is important to understand the differences between a NEW product and CHANGES to an existing product. ġ.4 Defining a new product compared to a product change.Note: At least one of the guiding principles must apply for a GTIN change to be required.Ī separate, unique GTIN is required whenever two products are different in any way that is relevant to the trading process, intended use, or point-of-care. ■ Label/Package: Is there a substantial change impacting the supply chain (e.g., how the trade item is shipped, stored, received or handled in the clinical setting)? ■ Label/Package: Is there a regulatory or liability requirement to disclose a change to the consumer and/or trading partner? care providers, consumers, patients, regulatory authorities and/or trading partners) expected to distinguish the changed or new product from previous/current products? ■ Product Contained in Package: Is a stakeholder (e.g. The following guiding principles should be considered by the brand owner when developing a GTIN assignment strategy for a new trade item and when introducing changes to an existing trade item. Note: The term ‘product’ as used throughout the GS1 Healthcare Allocation Rules refers to the trade items to which GTINs are assigned Finally, the communication of unique identification changes between trading partners is essential to ensure the right product is made available when needed. The unique identification of trade items 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.Īdditionally, the unique identification of trade items is crucial when complying with various regulations across the globe. Overall costs are minimised while efficiencies and patient safety improve when all partners in the supply chain adhere to the Healthcare GTIN Allocation Rules. These rules have been developed in accordance with the GS1 Global Standards Management Process (GSMP) and are considered a part of the GS1 system of standards.
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The Healthcare GTIN Allocation Rules are designed to help industry make consistent decisions about how to manage the unique identification of trade items. The Global Trade Item Number ® (GTIN ®) provides a global standard by identifying any trade item upon which there is a need to retrieve predefined information and that may be priced, or ordered, or invoiced at any point in the supply chain.
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