We are aware of an issue causing the title of some ARTG entries to disappear. We are investigating as a priority and hope to have this resolved as soon as possible.
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623 result(s) found, displaying 101 to 125
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH Q1A (R2); CPMP/ICH/2736/99
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Reference materialFAQs for health professionals importing and supplying medical devices
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/618604/2008 Rev. 9
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - 3AQ21a
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CAT/573420/2009
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User guideUser guide on how to submit shortage/discontinuation notifications to the TGA
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User guideThis user guide is for sponsors wanting to submit GMP clearance application by the TGA Business services (TBS) portal.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH E4; CPMP/ICH/378/95
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User guideUser guide for sponsors converting their dossier format from paper, CTD or NeeS to eCTD
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CHMP/EWP/191583/2005
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Reference materialProvides guidance for sponsors on the regulatory requirements for medicine presentation for listed medicines
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Reference materialIn 2022, the TGA initiated targeted compliance reviews for listed medicines that require warning statements on the label based on their inclusion of the herbal ingredients Foeniculum vulgare (fennel), fennel bitter seed dry, fennel sweet seed dry and/or fennel oil.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/CHMP/410869/2006.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH E15; EMEA/CHMP/ICH/437986/2006
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Reference materialThe TGA will be initiating targeted compliance reviews of selected listed medicines to evaluate evidence held to support indications related to exercise performance.
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User guideUser guide for sponsors who need to withdraw information from their eCTD dossiers and can be used as best practice for NeeS withdrawals
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Reference materialGuidance for applicants (sponsors, manufacturers and agents) preparing for pre-submission meetings related to applications
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH S1; EMA/CHMP/ICH/752486/
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH M4Q; CPMP/ICH/2887/99
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH E10; CPMP/ICH/364/96
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Reference materialGuidance on European Union guidelines for complementary medicine sponsors in Australia.
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User guideThis user guide will assist you in providing the required information for completing (and submitting) an application for an assessed listed medicine (either for new ARTG entries or changes to existing ARTG entries)
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Reference materialThe annual charge exemption (ACE) scheme is a self-declaration scheme
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Reference materialBatch release testing of biological medicines (excluding vaccines) is no longer required.