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Resources
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627 result(s) found, displaying 1 to 25
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User guideA step-by-step guide to completing the form
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FormsForm for sponsors to provide notice of Therapeutic vaping goods to Therapeutic Goods Administration
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FormsSponsors must report every six months in relation to unapproved therapeutic goods supplied under the SAS and Authorised Prescriber (AP) schemes.
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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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FormsThis checklist is to be used by sponsors to apply for priority review determination
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FormsThis checklist is intended to assist applicants to determine if they have provided all the necessary information to allow the TGA to make an informed decision on the determination application.
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User guideA user guide on how to change sponsor details in PI and labels.
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FormsChecklist to assist in a priority review designation application
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User guideThis user guide is for sponsors applying for a variation to the Australian Register of Therapeutic Goods (ARTG) entry of a medical device or IVD medical device.
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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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User guideThis user guide outlines how sponsors can access and use the Adverse Event Management System (AEMS) web portal.
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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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FormsAs of 25 June 2024, use this PDF form to order Influenza Reagents.
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FormsThis form allows sponsors of notified therapeutic vaping goods, which includes therapeutic vaping kits, to provide information to the TGA about the supply of those goods during a specified period, upon formal request by the Secretary or their delegate.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - ICH E6 (R2) Integrated Addendum
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FormsA list of TGA forms for prescription medicine sponsors.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/541760/2011
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FormsForms for notifying the TGA of a change in sponsorship.
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ChecklistsA checklist for sponsor intending to supply a therapeutic vaping device
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FormsA form for sponsors to notify the TGA of the date that they will commence marketing a product registered on the ARTG
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FormsMedicine safety issue notification form for sponsors
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ChecklistsThis checklist outlines key considerations for sponsors and manufacturers seeking to comply with Australia’s Unique
Device Identification (UDI) requirements. -
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FormsThis form is to be used by medical device manufacturers or their authorised representatives (sponsors) for mandatory reporting of adverse events associated with a medical device.
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User guideUser guide for sponsors converting their dossier format from paper, CTD or NeeS to eCTD