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623 result(s) found, displaying 201 to 225
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Reference materialGuidance for medical devices manufacturers on how we conduct Quality Management System (QMS) audits, roles and responsibilities for audits, aspects of conformity assessment certification and post-audit activities.
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Reference materialGuidance on procedure to undertake recalls and non-recall actions for therapeutic goods.
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Compositional guidelinesCompositional guideline for 'Conifer phytosterol complex' permitted for use in listed medicines
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Reference materialRegistered over-the-counter medicine application levels
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH Q4B Annex 10; EMA/CHMP/ICH/381133/2009
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH Q4B Annex 11; CHMP/ICH/730028/2009
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH Q4B Annex 12; CHMP/ICH/730808/2009
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Reference materialExternal evaluators are required to use their expertise to review the data provided by sponsors and prepare an assessment report.
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International scientific guidelines adopted in AustraliaThe general principles of this guideline are adopted. Please note that any references to FDA processes are not applicable in submissions to the TGA.
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User guideHow to withdraw your ARTG application, for medical device sponsors (includes importers and exporters).
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/CVMP/QWP/BWP/70278/2012-Rev1
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Reference materialRisk management plans for medicines and biologicals has been updated with new content, new Australia-Specific Annex and a new form
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FormsApply to import and supply substitute medicines under section 19A
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International scientific guidelines adopted in AustraliaWe have adopted this draft International Scientific Guideline - Data standards for drug and biological product submissions containing real-world data – Draft guidance for industry.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH Q10; EMA/CHMP/ICH/214732/2007
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Reference materialThe TGA has published a list of FAQs on issues raised by industry in relation to permitted indications
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Reference materialThe TGA no longer allocates proprietary ingredient numbers to certain categories of ingredient mixtures.
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User guideHow to search for medical device incident reports.
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Reference materialThe Australian Regulatory Guidelines for Prescription Medicines (ARGPM) assist applicants and sponsors to register new prescription medicines or vary existing registrations in Australia.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/507988/2013 (annex).
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FormsRequest cancellation of a therapeutic good on the Australian Register of Therapeutic Goods (ARTG)
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FormsUpdated form used to notify the TGA of proprietary ingredient mixtures for use in therapeutic goods