Resources
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637 result(s) found, displaying 476 to 500
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FormsPlease include this form in CTD Module 1.5 of your application dossier.
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FormsImport/export of unapproved therapeutic goods for experimental purposes
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FormsForm to apply to add an export name to a product registered in the ARTG.
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Compositional guidelinesCompositional guideline for 'Bacillus coagulans strain MTCC 5260' permitted for use in listed medicines
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Compositional guidelinesCompositional guideline for 'Bittern' permitted for use in listed medicines
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Compositional guidelinesCompositional guideline for 'sodium chondroitin sulfate derived from fermentation of Escherichia coli' permitted for use in listed medicines
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Compositional guidelinesCompositional guideline for 'Palmidrol' permitted for use in listed medicines
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User guideUser guide on how to submit shortage/discontinuation notifications to the TGA
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FormsApplication for consent to supply goods that do not conform with subsection 9(2) of TGO No. 92 - Standard for labels of non-prescription medicines - section 14/14A
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FormsProposal form for a new Approved Cell and Tissue Name (ACN)
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FormsSuspected adverse events that occur after having a vaccination can be reported to the TGA
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User guideUser guide for sponsors converting their dossier format from paper, CTD or NeeS to eCTD
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User guideUser guide for sponsors who need to withdraw information from their eCTD dossiers and can be used as best practice for NeeS withdrawals
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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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FormsUse this form to seek TGA advice on a biowaiver justification proposed for inclusion in an application to register a new medicine for oral ingestion
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FormsThis form is to be completed by the ingredient owner to authorise sponsors to use a protected ingredient that is the subject of an exclusivity period to list a medicine in the Register
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User guideFrom 14 September 2020, we will publish all notifications of shortages for reportable medicines on the Medicine Shortages Reports Database
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User guideThis user guide provides guidance about preparing the summary page for Consumer Medicine Information (CMI) documents.
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User guideThis user guide outlines how to communicate effectively with consumers using the revised Consumer Medicine Information (CMI) template
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User guideHow to get approved PI and CMI documents for OTC medicines published on our website.
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User guideA user guide for applicants using the TGA Business services (TBS) portal to complete an online application form for a new substance application.
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User guideThis user guide is for sponsors applying to change the entry in the ARTG for a registered non-prescription OTC medicine.