Within the healthcare sector there are many examples of certification marks. A certification mark is a symbol, logo or wording on a product that declares conformance to a regulated set of criteria (e.g., European Certification Mark CE). When a product is changed to include a certification mark (which was not previously shown on the packaging or product itself) a new GTIN should be allocated for markets where the certification mark is of relevance. It is a key principle of GTIN Allocation that the GTIN uniquely identifies the product and its packaging configuration.
A change to packaging to add a new, or remove an existing certification mark (e.g., European Certification Mark CE), that has significance to regulatory bodies, trading partners or to the end consumer, requires assignment of a new GTIN.