This content is current only at the time of printing. This document was printed on 22 June 2018. A current copy is located at https://apvma.gov.au/node/20276
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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 for applications to register a new product which is a repack of your own registered product (Item 8).
To have your application fast-tracked, in addition to meeting the item 8 requirements, your application must also:
- be using your own product as a reference product
- not have any protected data associated with that reference product
- include payment of the full fee at lodgement.
Your application must meet all these requirements to qualify for fast-tracking, otherwise the current Item 8 timeframe (3 months) will apply. If we need you to provide us with additional information the assessment period may be extended by two months to a total assessment period of five months.
How to apply
If your application is eligible for fast-tracking the decision tree will direct you to the fast-track application form.
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 proposed label and manufacturer’s declaration/s. The seven day period to supply supporting documentation does not apply to fast-track applications.