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Collection content
109 result(s) found, displaying 81 to 90
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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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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
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User guideElectronic data interchange for ICSR submission using the E2B R2 format
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FormsForms and proformas for CTD Module 1 submissions, including administrative requirements and supporting documentation for lodging applications with the TGA.