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    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


    Provisional determination process diagram

    https://hotcopper.com.au/data/attachments/1754/1754639-009e5872ab87d4479d507066e9daca66.jpg

    Last edited by Mozzarc: 04/10/19
 
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