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    • Healthcare GTIN Allocation Rules
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    • About Healthcare GTIN Allocation Rules
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5. Add or remove certification mark

New GTIN for:
Item
yes
Existing higher-level packaging
yes

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.

New GTIN for:
Item
yes
Existing higher-level packaging
yes

Example business scenarios that require GTIN change

Package:

  • A change of a certification mark of one country to that of another.
  • Certification Marks that appear, or change, on product labels that impact global distribution channels due to country licence or registration, must be communicated between trading partners and therefore require a GTIN change.
  • Removal of a certification mark, for example CE.

Product:

  • Addition of an European Certification Mark CE.
  • Removal of a CSA certification mark from a product's packaging.

NOTE: However, it should also be noted that when a certification mark is added to enable sales in a new country/market it has no impact on countries/markets where the product was previously sold – in this case there is no need to allocate a new GTIN in the scenario above.

Additional information

  • For the purpose of interpretation of this rule, a certification mark is a symbol, logo or wording on a product that declares a product has met specific criteria and standards in formulation, harvesting, processing or manufacturing (e.g., European Certification Mark) and that can be externally verified by a certification authority or agency which can be either a public or private authority.

Relevant guiding principles

Is the consumer or supply chain partner expected to distinguish the difference between old vs. new product? Is there a change in a regulated declaration to the consumer and/or trading partner? Is there a substantial impact to the supply chain (e.g. how the product is shipped, stored, received)?

More about guiding principles
 
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