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889 result(s) found, displaying 851 to 875
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International scientific guidelines adopted in AustraliaCPMP/ICH/1840/01 adopted by the Therapeutic Goods Administration (TGA)
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International scientific guidelines adopted in AustraliaCPMP/EWP/567/98 adopted by the Therapeutic Goods Administration (TGA)
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International scientific guidelines adopted in AustraliaEMA/HMPC/201116/2005 Rev. 2 adopted by the Therapeutic Goods Administration (TGA)
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International scientific guidelines adopted in AustraliaEMA/CHMP/SWP/81714/2010 adopted by the Therapeutic Goods Administration (TGA)
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International scientific guidelines adopted in AustraliaEMA/HMPC/CHMP/CVMP/162241/20051 Rev. 3 adopted by the Therapeutic Goods Administration (TGA)
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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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Reference materialThe purpose of this guidance is to assist applicants compile a literature based submission (including mixed applications), and replaces the previous TGA guidance: Literature-Based Submissions - Points to consider (2003).
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User guideUser guide updated to include final report and additional information requirements following amendments to the Therapeutic Goods (Medical Devices) Regulations 2002.
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FormsMedicine safety issue notification form for sponsors
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International scientific guidelines adopted in AustraliaCPMP/SWP/465/95 adopted by the Therapeutic Goods Administration (TGA).
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FormsYou must submit this notice before you import a cannabis vaping device or accessory.
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FormsYou must submit this notification to the TGA to qualify as a transitional manufacturer and be exempt, between 1 January 2024 and 1 December 2024, from the requirement to hold a manufacturing licence for therapeutic vaping goods.
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User guideThe OTC application categorisation framework defines the different OTC medicine application levels and identifies the key application criteria
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User guideDetermining the route for an over-the-counter (OTC) application and assessing the risk to consumers with the umbrella brand extension.
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User guideThe OTC Dossier Documents Matrix (the 'matrix') provides a summary of which documents are required for each application level (N1, N2, N3, N4, N5, C1, C2, C3 or C4)
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Reference materialWe may decide to seek advice from an expert advisory committee during the evaluation of an application to register or change an over-the-counter (OTC) medicine
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Reference materialGuidance on the use of permitted indications in Listed complementary medicines
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User guideThe cover letter (letter of application) needs to provide useful information regarding the nature and scope of the application
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Reference materialGuidance to help sponsors understand the process of submitting priority inclusion application
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User guideThis user guide is for sponsors applying to change the entry in the ARTG for a registered non-prescription over-the-counter (OTC) medicine
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FormsUse this form to apply for an Approved Biological Name.
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User guideApproved PI and CMI documents for OTC medicines can now be published on the TGA website
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - 3AB5.