Resources
Search our resources for user guides, checklists, international scientific guidelines, compositional guidelines and forms.
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637 result(s) found, displaying 451 to 475
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FormsThis form collects information about the legal entity making applications under the Therapeutic Goods Act 1989.
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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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Compositional guidelinesCompositional guideline for 'EPA-rich Nannochloropsis oculata oil' permitted for use in listed medicines
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FormsInformation and links to the medical devices priority applicant determination application form.
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FormsComplete this form when submitting a new DMF to TGA, or when updating an existing DMF already held by the TGA.
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Compositional guidelinesCompositional guideline for 'Leptospermum scoparium oil' permitted for use in listed medicines
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User guideInformation to assist medical practitioners in submitting AP applications via the online system
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User guideInformation to assist medical practitioners in submitting SAS applications via the online system
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FormsFind out how the free trade agreement affects your application to include a product on the Australian Register of Therapeutic Goods.
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Compositional guidelinesCompositional guideline for 'Bacillus coagulans Strain MTCC 5856' permitted for use in listed medicines
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Compositional guidelinesCompositional guideline for 'Beeswax Alcohols' permitted for use in listed medicines
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Compositional guidelinesCompositional guideline for 'Euglena gracilis whole cell dry' permitted for use in listed medicines
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Compositional guidelinesCompositional guideline for 'Nicotinamide riboside chloride' permitted for use in listed medicines
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FormsFind further information about inspection and audit feedback forms.
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Compositional guidelinesCompositional guideline for '2'-Fucosyllactose' permitted for use in listed medicines
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Compositional guidelinesCompositional guideline for 'Lacto-N-tetraose (LNT)' permitted for use in listed medicines
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User guideA step-by-step guide for Australian manufacturers of therapeutic goods.
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FormsInformation and templates for manufacturers making an Australian declaration of conformity.
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User guideSponsor user guide updated to include final report and additional information requirements following amendments to the Therapeutic Goods (Medical Devices) Regulations 2002.
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User guideFind out when you should use a literature-based submissions (LBS) for your application.
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Compositional guidelinesCompositional guideline for '3'-Sialyllactose sodium' permitted for use in listed medicines
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Compositional guidelinesCompositional guideline for 'Lacto-N-neotetraose' permitted for use in listed medicines
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Compositional guidelinesCompositional guideline for 'Hydrolysed Chicken Cartilage Extract' permitted for use in listed medicines
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Compositional guidelinesCompositional guideline for '6'-Sialyllactose Sodium' permitted for use in listed medicines
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Compositional guidelinesCompositional guideline for 'Dihydrocapsiate (DHC)' permitted for use in listed medicines