Fast-tracking simple applications

We’re improving our processing timeframes to provide faster registration for simple applications.

We’re now able to provide a 21-day processing timeframe from lodgement to finalisation for applications to register a new product which is a repack of your own registered product (Item 8).

Eligibility

To have your application fast-tracked, in addition to meeting the item 8 requirements, your application must also:

  • nominate your own product as a reference product
  • not include any protected data associated with the reference product.

Your application must meet all these requirements to qualify for fast-tracking, otherwise the current Item 8 timeframe (3 months) will apply. An extended assessment period of 5 months may also apply if we need you to provide us with additional information.

How to apply

If your application is eligible for fast-tracking the decision tree will direct you to the fast-track process.

The fee and application requirements will remain the same for an application submitted through this process as a standard repack (item 8) application.

All information must be submitted with a fast-track application. This includes the full application fee, proposed label and relevant declarations from manufacturers and applicants. The seven day period to supply supporting documentation does not apply to fast-track applications.

To protect your privacy, please do not include contact information in your feedback. If you would like a response, please contact us.