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629 result(s) found, displaying 1 to 25
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FormsAs of 25 June 2024, use this PDF form to order Influenza Reagents.
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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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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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ChecklistsA compliance checklist for advertisers applying to use a restricted representation.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICHER(R1); EMA/CHMP/ICH/436221/2017
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User guideHow to install the ADR reporting template in the Best Practice software.
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User guideInstalling the ADR reporting template in the Medical Director software.
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Compositional guidelinesCompositional guideline for Pediococcus pentosaceus CECT 8330 permitted for use in listed medicines.
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Compositional guidelinesCompositional guideline for Urolithin A permitted for use in listed medicines.
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ChecklistsA checklist to help medical device manufacturers demonstrate compliance with the Essential Principles.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/QWP/BWP/259165/2019
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/541760/2011
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User guideA step-by-step guide to completing the form
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User guideThis document applies to all regulatory activities in electronic Common Technical Document (eCTD) format.
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User guideUser guide for sponsors that provides the pilot specification and guidance information relevant for preparation of an electronic Common Technical Document (eCTD) sequence to the TGA.
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Compositional guidelinesCompositional guideline for Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate permitted for use in listed medicines.
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User guideHow to view and respond to notifications related to an application for consent to import, supply, or export medical devices that do not meet the Essential Principles.
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ChecklistsThese checklists summarise key obligations for psychiatrists applying to prescribe and access MDMA and psilocybine under the Authorised Prescriber scheme.
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User guideThis user guide is for sponsors wanting to submit GMP clearance application by the TGA Business services (TBS) portal.
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FormsUse this form to report suspected adverse reactions to vaccines and prescription, over the counter and complementary medicines.
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FormsThis form is for sponsors to report Significant Safety Issues (SSIs) and Urgent Safety Measures (USMs) to the TGA.
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FormsUpdated form used to notify us of proprietary ingredient mixtures for use in therapeutic goods.
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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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ChecklistsThis checklist can help you assess if your advertising complies with legislative requirements.