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771 result(s) found, displaying 751 to 771
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User guideUser guide for sponsors and manufacturers wanting to submit data in the NeeS format.
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Reference materialWe have published updated guidance for OTC medicines to better assist applicants to register or make a change to a registered OTC medicine
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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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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 application categorisation framework defines the different OTC medicine application levels and identifies the key application criteria
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FormsThis form is for sponsors to report Significant Safety Issues (SSIs) and Urgent Safety Measures (USMs) to the TGA.
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FormsYou must submit this notice before you import a cannabis vaping device or accessory.
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ChecklistsA checklist for sponsor intending to supply a therapeutic vaping device
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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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Reference materialThis guidance intends to outline for sponsors and manufacturers the types of RWE relevant in the Australian context.
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Reference materialThe ARGLMRCM presents guidance in separate documents to facilitate timely updates.
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Reference materialdescribes the minimum approach considered to be acceptable to achieve validation of the test procedures used for complementary medicines (products) and starting materials for use in complementary medicines
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Reference materialoverview of identification of herbal materials and extracts
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Reference materialOverview of stability testing of Listed complementary medicines
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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 materialGuidance on the use of permitted indications in Listed complementary medicines
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Reference materialThis guidance is for both licenced manufacturers and community pharmacists involved in the manufacture of compounded medicines or dose administration aids (DAAs).
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FormsOnline application form to become an Australian Conformity Assessment Body
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH M4S; CPMP/ICH/2887/99 - Safety
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – EMEA/CHMP/QWP/49313/2005 Corr
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FormsForm for sponsors to provide notice of Therapeutic vaping goods to Therapeutic Goods Administration