What, you mean something like this?Provisionaldetermination
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A step-by-step guide for prescription medicines
24October 2018
This guidance is for sponsors intending to use the Provisional approval pathway for prescription medicines. This pathway allows a time-limited provisional registration on the Australian Register of Therapeutic Goods (ARTG).
This guidance assists sponsors with the process of applying for a provisional determination, which is the first step of the provisional approval pathway.
On this page:Provisional determination | Determination process for Provisional approval | Submitting yourapplication for registration
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