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889 result(s) found, displaying 351 to 375
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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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Reference materialFrequently asked questions added
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Reference materialThis section informs advertisers, including manufacturers, pharmacists and health professionals, of their responsibilities when advertising therapeutic goods.
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Reference materialInformation on the types of search results for the System for Australian Recall Actions (SARA) database
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Reference materialThis document sets out the testing requirements to verify that COVID-19 Rapid Antigen Test (RAT) kits included in the ARTG meet the analytical sensitivity requirements outlined by the World Health Organisation.
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Compositional guidelinesCompositional guideline for 'Leptospermum scoparium oil' permitted for use in listed medicines
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Reference materialInformation to assist medical practitioners in submitting AP applications via the online system
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Reference materialInformation to assist medical practitioners in submitting SAS applications via the online system
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Reference materialWe have published a social media acceptable use policy that advertisers can use on their digital platforms.
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Reference materialThis guidance explains part 6 of the Code, which outlines requirements for using endorsements and testimonials in advertisements about therapeutic goods.
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Reference materialTwenty-nine medicines added, three medicines updated
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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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Reference materialChanges to the process for including Class I non-sterile, non-measuring medical devices and Class 1 IVD medical devices in the ARTG
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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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Reference materialInformation for manufacturers and sponsors on COVID-19 rapid antigen tests (RATs) regulatory requirements and processes.
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Reference materialUpdate to TGA's conditions and advertising requirements for COVID-19 rapid point-of-care tests.
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FormsFind further information about inspection and audit feedback forms. On this page they are available in pdf and Microsoft Word formats to download.
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Reference materialManufacturers of medicines and biologicals are regularly inspected by the TGA using a risk-based approach to ensure compliance with manufacturing principles.
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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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Reference materialUpdated guidance for businesses using rapid antigen tests approved by the TGA as point-of-care tests.