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Guidance on product changes in ELF3

31 August 2012

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Types of changes

The types of changes are:

  • New
  • Group / Grouping
  • Vary / Variation
  • Correction of ARTG Record (ARTG).

Definitions for these terms are included below.

New:

The intended change creates a separate and distinct good, as defined under the Act, therefore a unique (new) AUST L number will be issued. An application fee equivalent to a new product is payable.

Group / Grouping:

The intended change is permitted under the Groups Order, therefore certain restrictions and conditions are applied to the application. A grouping application is only appropriate when the goods are intended to replace the currently supplied goods. The existing AUST L number is maintained. An application fee equivalent to a new product is payable.

Vary / Variation:

A minor change to a product's details. The current AUST L number is maintained. An application fee is payable.

Correction of ARTG Record:

Two types of change are possible:

  1. A minor change to a product's details. The change is made by the sponsor through an ELF application. No application fee is payable.
  2. Section 9D change: A change under Section 9D of the Act is made after a successful application to the Director of the Listing and Operations Section (LOS) of the Office of Complementary Medicine (OCM), who acts as the delegate of the Secretary. The change is only considered if the current listing has omissions or mistakes that were made while listing the product. The application can be in the form of a letter, fax or email to the Director of the LOS. The applicant must demonstrate how the omission or mistake was made and what measures will be taken in the future to prevent similar omissions or mistakes recurring. The current AUST L number is maintained. An application fee is payable upon approval of the Section 9D application.

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