This content is current only at the time of printing. This document was printed on 24 February 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 from lodgement to finalisation 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:
- 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.