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Reference materialThe Annual Charge Exemption (ACE) declaration period occurs between 1 July and 22 July.
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Reference materialApply for access and manage your account details.
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Reference material& & &
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Reference materialNew clinician information sheets on opioid analgesic tapering.
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Reference materialNew Australian Electronic Submission Basics guidance available
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Reference materialFrom 1 June 2021, how you report Medicine Shortages has changed
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User guideUser guide on how to submit shortage/discontinuation notifications to the TGA
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FormsUse this form to propose a new approved herbal name or herbal substance name.
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Reference materialImportant information on the Database of TGA Laboratory testing results.
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FormsApplication form to import, supply or export a therapeutic good that does not comply with standards.
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FormsApplication for consent to supply goods that do not conform with subsection 9(2) of TGO No. 92 - Standard for labels of non-prescription medicines - section 14/14A
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Reference materialQuestions and answers about the ACSS - NAS work sharing initiative
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Reference materialThese case studies provide practical examples that demonstrate our guidance, legislation and policy in action.
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Reference materialSpecial Access Scheme - portal updates
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FormsProposal form for a new Approved Cell and Tissue Name (ACN)
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Reference materialAdvice for sponsors implementing changes in 2021.
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Reference materialGuidance on the TGA's expectations concerning clinical performance requirements and risk mitigation for in vitro diagnostic medical devices intended to be used as self-tests for seasonal influenza.
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Reference materialAn overview of TGA's proposed safety and quality requirements for unapproved vaporiser nicotine products
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Reference materialThis guidance summarises the regulatory approach of the TGA for software based medical devices
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Reference materialThis guidance outlines the broad approach adopted by the TGA to identify and manage risk associated with therapeutic goods
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FormsSuspected adverse events that occur after having a vaccination can be reported to the TGA
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Reference materialGuidance now includes advice on lodgement of provisional variation applications
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Reference materialWatch this video for an overview of the TGA compliance framework