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.

Which application form do you need?

Application guidance

Specific information on completing this application form is provided below. Once you are familiar with the content you can proceed to ‘Start an application’ at the button below.

Please note: the fees referenced in this tailored guidance take effect from 1 July 2020. For a list of fees and charges up to 30 June 2020, please view the?timeframe and fees section on our website.