Resources
Search our resources for user guides, checklists, international scientific guidelines, compositional guidelines and forms.
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677 result(s) found, displaying 1 to 25
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Compositional guidelinesCompositional guideline for bacillus coagulans strain ATCC PTA-126829 permitted for use in listed medicines.
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Compositional guidelinesCompositional guideline for magnesium L-threonate monohydrate permitted for use in listed medicines.
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Compositional guidelinesCompositional guideline for hydrocarbons, C6-C20, polymers, hydrogenated permitted for use in listed medicines.
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Compositional guidelinesCompositional guideline for styrene/isoprene/styrene block copolymer permitted for use in listed medicines.
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Compositional guidelinesCompositional guideline for mitoquinol mesilate permitted for use in listed medicines.
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Compositional guidelinesCompositional guideline for gamma glutamylcysteine permitted for use in listed medicines.
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FormsUse this form to apply for approval of a new Technical Master File (TMF), an annual update to an approved TMF, or a significant update to an approved TMF.
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FormsUse this form to apply for approval of a new Type II Plasma Master File (PMF), an annual update to an approved Type II PMF, or a significant update to an approved Type II PMF.
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FormsReport suspected adverse reactions to vaccines, prescription medicines, over-the-counter medicines and complementary medicines.
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FormsReport a suspected adverse event following immunisation (AEFI) to the TGA. Find out what information to provide and how your report supports vaccine safety monitoring in Australia.
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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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ChecklistsThese checklist summarises key obligations for psychiatrists applying to prescribe and access MDMA and psilocybine under the Authorised Prescriber scheme.
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User guideThis document applies to all regulatory activities in electronic Common Technical Document (eCTD) format.
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User guideA guide for using the TGA Business services (TBS) portal for listed and assessed listed medicine applications.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/EWP/2284/99 Rev. 2
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/BPWP/144552/2009 rev. 2
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/BWP/303353/2010 Rev 3
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/CVMP/QWP/496873/2018
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/CVMP/3Rs/94436/2014
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CAT/GTWP/671639/2008 Rev. 1 - corr
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FormsThe application form to amend the current Poisons Standard.
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User guideUse this guide to prepare a cover letter for an over-the-counter (OTC) medicine application.
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User guideKnow how to submit data in the electronic Common Technical Document (eCTD) format for a non-prescription medicine application.
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Checklistschecklist that helps sponsors and manufacturers identify relevant industry standards and evidence needed to demonstrate compliance of medicinal cannabis vaping devices with the Essential Principles of Safety and Performance.