Resources
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637 result(s) found, displaying 401 to 425
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FormsForms for notifying the TGA of a change in sponsorship.
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FormsThis form is for applying to become an Australian Conformity Assessment Body.
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FormsThis form is to be submitted with the expression of interest when applying for membership to a TGA expert committee.
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FormsUse this form to apply for an Approved Biological Name.
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FormsUse this form to apply for an Australian Approved Name (AAN).
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FormsUse this form to propose a new approved herbal name or herbal substance name.
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User guideHow to search TGA business services for approved ingredients and accepted TGA terminology.
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ChecklistsA checklist for sponsor intending to supply a therapeutic vaping device
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Compositional guidelinesCompositional Guideline for Theanine permitted for use in listed medicines.
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FormsTemplates for manufacturers to make Australian Declarations of Conformity for an in vitro diagnostic medical device.
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User guideThis document replaces AU eCTD specification - Module 1 and regional information Version 3.0 and contains updated information.
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FormsYou must submit this notification to the TGA to qualify as a transitional manufacturer and be exempt, between 1 January 2024 and 1 December 2024, from the requirement to hold a manufacturing licence for therapeutic vaping goods.
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FormsYou must submit this notice before you import a cannabis vaping device or accessory.
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FormsA list of TGA forms for prescription medicine sponsors.
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FormsSponsors can use this form to apply for an additional trade name for a registered prescription medicine, under section 23 of the Therapeutic Goods Act 1989.
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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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FormsPrescription medicines Minor Variation E-form now available
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FormsFind out what process to follow if a product is manufactured using a human embryo or a human embryonic stem cell, or any material sourced from such an embryo or stem cell.
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FormsUse this form to report defects that you think have arisen during manufacture, storage or handling of a medicine or vaccine.
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FormsUse these forms to apply for a permit to export human substances from Australia
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User guideThis user guide outlines how sponsors can access and use the Adverse Event Management System (AEMS) web portal.
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Compositional guidelinesCompositional Guideline for calcium fructoborate tetrahydrate permitted for use in listed medicines.
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Compositional guidelinesCompositional Guideline for Cyclocarya paliurus leaf extract dry.
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Compositional guidelinesCompositional guideline for '3-Fucosyllactose' permitted for use in listed medicines
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FormsThis form is to assist users of the Electronic Lodgement Facility (ELF) seeking preclearance for animal derived ingredients by detailing what the TGA is looking for and what supporting documents need to be provided.