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889 result(s) found, displaying 376 to 400
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Reference materialAnswers to frequently asked questions in relation to the supply of disinfectant products.
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FormsInformation and templates for manufacturers making an Australian declaration of conformity.
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Reference materialActive ingredient categories for medicinal cannabis products
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FormsThis portal allows for applications to be submitted online
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Reference materialFind out when you should use a literature-based submissions (LBS) for your application.
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Reference materialUpdate to the conditions of approval on the ARTG for HIV POCT
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Reference materialInformation on the types HIV tests available and guidance for manufacturers and sponsors on clinical performance requirements and risk mitigation strategies for HIV tests supplied in Australia.
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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 '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
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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 'Lacto-N-neotetraose' permitted for use in listed medicines
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Reference materialThis standard sets out minimum safety and quality requirements for unapproved and export only nicotine vaping products that are imported into, manufactured or supplied in, or exported from, Australia.
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Reference materialThis guidance document provides information about when and how clinical decision support software is regulated in Australia by the TGA.
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FormsPlease include this form in CTD Module 1.5 of your application dossier.
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FormsImport/export of unapproved therapeutic goods for experimental purposes
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FormsApply for a Certificate of Free Sale or an Export Certificate for a medical device.
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FormsForm to apply to add an export name to a product registered in the ARTG.
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Reference materialThe conformity assessment certification and audit requirements for certain medical devices have changed.
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Reference materialRegulatory changes to importing nicotine vaping products
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Reference materialRegulatory changes to importing, supplying and advertising nicotine vaping products
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Reference materialGuidance for advertising - claims such as 'TGA approved' must not be used in advertisements for therapeutic goods.
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Reference materialPresentation from TGA Transformation Stakeholder Engagement Forums
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Reference materialEveryone can play an important role in monitoring the safety of therapeutic goods in Australia.