Guiding principles
The following guiding principles should be considered by any brand owner when introducing changes to an existing product and also when developing a GTIN assignment strategy for a new product.
At least one of the guiding principles must apply for a GTIN change to be required.
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Product Contained in Package: Is a stakeholder (e.g. care providers, consumers, patients, regulatory authorities and/or trading partners) expected to distinguish the changed or new product from previous/current products? |
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Label/Package: Is there a regulatory or liability requirement to disclose a change to the consumer and/or trading partner? |
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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)? |
A 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.