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541 result(s) found, displaying 1 to 25
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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 guideA step-by-step guide to completing the form
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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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Reference materialGuidance on how to change sponsor details in PI and labels
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FormsForm for sponsors to provide notice of Therapeutic vaping goods to Therapeutic Goods Administration
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FormsChecklist to assist in a priority review designation application
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Reference materialThis road map presents an overview of the requirements for supplying an IVD for Australian sponsors.
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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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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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Reference materialNew features have been launched for the Medical Devices Consent for Non-compliance Dashboard in TBS Business Services Portal
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Reference materialConsent to import, supply or export a medical device that does not comply with the Essential Principles
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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 guideHow to successfully complete and submit an application for consent to import, supply, or export medical devices that do not meet the Essential Principles.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/VWP/457259/2014
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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/PRAC/222346/2014
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FormsUpdated form used to notify the TGA of proprietary ingredient mixtures for use in therapeutic goods
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ChecklistsA checklist for sponsor intending to supply a therapeutic vaping device
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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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ChecklistsA compliance checklist for advertisers applying to use a restricted representation.
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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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Reference materialThis guidance intends to outline for sponsors and manufacturers the types of RWE relevant in the Australian context.