2. Declared formulation or functionality
New GTIN for:
Item
Existing higher-level packaging
Product formulas change and new functionalities are added to products all the time. Some formula changes may be legally-required to be declared on packages. Additionally, some formula changes may result in legal handling
and / or regulatory filing requirements that are different than they had been in previous versions of the product.
“Functionality” is defined as the particular use or set of uses for which something is designed.
“Formulation” is defined as a list of the ingredients or components used to create a trade item.
A change to the formulation or functionality that affects the legally required declared information on the packaging of a product only requires the assignment of a new GTIN if the brand owner expects the customer or supply chain partner to distinguish the difference between the products prior and after the change. Both conditions must be met requiring the assignment of a new GTIN.
New GTIN for:
Item
Existing higher-level packaging
Example business scenarios that require GTIN change
Formula:
- Change to an active ingredient in a product
- Change to an excipient in a product.
- Change to a different material for the primary packaging.
- The addition of a new assay to laboratory testing equipment.
- A hospital pharmacy prepares a specific product designed for a specific patient. In some cases, this is referred to a "personalised medicine".
Functionality:
- A change in form, fit, or function to a mandatory component affecting intended use, requires a change to the GTIN and/or GTIN plus serial number of the entire configurable medical device. Mandatory components are those that are required to deliver the functionality of the device. Changes to or the removal of, a mandatory component, impacting device form, fit, or function, require a GTIN change.
- Changes to optional components impacting device form, fit, or function, require a GTIN change. Similarly, removal of optional components from the set of available components requires a GTIN change.
- A major change in medical device software functionality affecting, form, fit, or function and intended use, requires a GTIN change. Examples of major changes include new or modified algorithms, database structures, architecture, new user interfaces, or new channels for interoperability.
