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Guidance on product changes in ELF3
Terminology used to describe changes
The terms used to describe changes are:
- Update addition
- Update deletion
Definitions for these terms are included below.
Generally applies to changes made to a product's ARTG record as a result of sponsor initiated changes, e.g. change of manufacturer or changes to indications or ingredients (changes to the manufacturer details do not attract a fee). A change to an ARTG listing may attract a fee.
This generally applies when information is required to be entered into a mandatory field in ELF 3 when the field was previously empty. Update addition changes are generally due to system changes (e.g. the data model changes between the new and old ARTG and updated versions of ELF). They also provide for changes to the rules, such as the addition of mandatory warning statements. An update addition to an ARTG listing usually does not attract a fee.
Applies when there is a deletion of information from a non-mandatory field. An update deletion to an ARTG listing usually does not attract a fee.
Applies when there is an addition of information to the product's record, e.g. addition of an ingredient or export name. An addition to an ARTG listing may attract a fee.
Removal of information from the product ARTG record. A deletion to an ARTG listing may attract a fee.