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638 result(s) found, displaying 1 to 25
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/EWP/239/95 Rev. 1, Corr.1*
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/EWP/239/95 final
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User guideUpdated information for registered users of the Australian Adverse Drug Reaction Reporting System
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FormsSuspected adverse events that occur after having a vaccination can be reported to the TGA
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User guideHow to use the ADR reporting template in the Best Practice software
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User guideUsing the ADR reporting template in the Medical Director software
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User guideInstalling the ADR reporting template in the Medical Director software.
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User guideHow to install the ADR reporting template in the Best Practice software.
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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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FormsThe completed assurances form is required in Module 1.5 of your OTC new medicine N2 application
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FormsThe completed assurances form is required in Module 1.5 of your OTC new medicine N1 application
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ChecklistsThis checklist assists sponsors to prepare a change application at the C1 level for a registered OTC medicine.
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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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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - ICH E6(R3) Guideline for Good Clinical Practice
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FormsThe application form to amend the current Poisons Standard.
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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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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