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623 result(s) found, displaying 1 to 25
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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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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 outlines how sponsors can access and use the Adverse Event Management System (AEMS) web portal.
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User guideA step-by-step guide to completing the form
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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 materialGuidance on how to change sponsor details in PI and labels
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FormsA list of TGA forms for prescription medicine sponsors.
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FormsThis checklist is to be used by sponsors to apply for priority review determination
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Reference materialAdvice for sponsors implementing changes in 2021.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/PRAC/222346/2014
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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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Reference materialAnswers to frequently asked questions in relation to the supply of disinfectant products.
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Reference materialThere is significant interest from potential sponsors and manufacturers to understand how disinfectants are regulated and how to supply them
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FormsChecklist to assist in a priority review designation application
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Reference materialAnswers to frequently asked questions in relation to the pharmacovigilance obligations of sponsors of medicines on the ARTG
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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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Reference materialInformation for manufacturers and sponsors on COVID-19 rapid antigen tests (RATs) regulatory requirements and processes.
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Reference materialInformation about what to include in the PI and CMI for products included in the Black Triangle Scheme.
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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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Reference materialGuidance to help sponsors understand the process of submitting priority inclusion application
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Reference materialLearning modules for sponsors of listed medicines as a supplement to Evidence Guidelines.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/56793/2014
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - 3CC17a