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Collection content
111 result(s) found, displaying 81 to 90
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FormsUse this form for Category 1 and Comparable Overseas Regulator (COR) report-based prescription medicines applications, or variations.
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FormsThe Pre-submission Planning Form (PPF) provides the TGA with the necessary information on the scope and scale of application to arrange appropriate resourcing for the processing and evaluation of an application.
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FormsApplication form to import, supply or export a therapeutic good that does not comply with standards.
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FormsFind out how the free trade agreement affects your application to include a product on the Australian Register of Therapeutic Goods.
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User guideFind out when you should use a literature-based submissions (LBS) for your application.
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User guideUser guide on how to submit shortage/discontinuation notifications to the TGA
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BlogYou might see a good deal on an overseas website, however, these health products are not approved for supply in Australia and have not been assessed by the TGA for safety, quality or effectiveness. You are not only risking your health, but you may also be left out of pocket if your online purchase is stopped at the border.
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User guideThis user guide describes how to change sponsor details in the Product Information (PI) and labels for prescription medicines
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User guideA user guide on how to change sponsor details in PI and labels.
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FormsSponsors should note that the Bioequivalence Study Information Form (BSIF) has been amended