This content is current only at the time of printing. This document was printed on 27 May 2022. A current copy is located at https://apvma.gov.au/taxonomy/term/17901
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I want to register a product that is the same as a reference product
Registering a new product that is the same as a registered reference product is also known as a ‘repack’.
The new product must be the same formulation with the same ingredients as the reference product, be in the same containers and be manufactured by a manufacturer of the reference product. The use pattern, label claims and use instructions for the new product must be the same as those of the reference product. The legislated definition of 'the same' can be found in the Legislation section of this page.
Additional marketing labels for an existing product can be obtained through an application for approval of an additional label—an Item 10A.
Applications to register a product that is the same as a reference product are processed via a fixed fee, non-technical application (Item 8). Applications for repacks of your own product where no protected data is associated with the reference product will be eligible for fast track.
Note: Once the repack product is registered there is no ongoing relationship between the new product and the reference product.