Where the intended change does not create a 'separate and distinct' good - Section 16 (1A) of the Act outlines the criteria which make listed medicines (other than those listed for export only) 'separate and distinct' goods - there are provisions in the legislation for certain details to be amended on a medicine's ARTG entry, upon request by the sponsor, and maintain the same AUST L number. Minor changes to listed medicines on the ARTG (other than those listed for export only) are made via the TBS system. For further information, including the types of changes that incur a fee, refer to the document: Guidance on product changes in ELF 3.
If the intended change to the listed medicine creates a good that is considered to be separate and distinct from the existing good, sponsors are required to submit a new application to list the goods and a new AUST L number will be issued (unless the medicine is eligible for 'grouping' under the existing AUST L number - see Therapeutic Goods (Groups) Orders.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.