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623 result(s) found, displaying 451 to 475
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Reference materialLearn how we manage medical device adverse event reports.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/EWP/280/96 Corr 1
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH Q1C; CPMP/ICH/280/95
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User guideUser guide on how to submit data in the electronic Common Technical Document (eCTD) format.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/483572/2012 - corr1.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/CHMP/BMWP/32775/2005 Rev. 1.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/EWP/14377/2008.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/QWP/450/03 - Rev.1, EMEA/CVMP/511/03 - Rev.1.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/HMPC/104613/2005 Rev.1.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/HMPC/166326/05.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/EWP/2986/03 Rev. 1.
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User guideHow to view and respond to notifications related to an application for consent to import, supply, or export a medical device that does not comply with the Essential Principles (EPs).
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Reference materialThis document sets out the testing requirements to verify that COVID-19 Rapid Antigen Test (RAT) kits included in the ARTG meet the analytical sensitivity requirements outlined by the World Health Organisation.
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Reference materialNot everything that meets our definition of a biological is regulated as a biological
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Reference materialUpdated guidance for businesses using rapid antigen tests approved by the TGA as point-of-care tests.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CHMP/EWP/4713/03.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/257022/2017
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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 - 3AB5.
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Reference materialGuidance now includes advice on lodgement of provisional variation applications
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FormsUse this form to report defects that you think have arisen during manufacture, storage or handling of a medicine or vaccine.
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Reference materialAll collection swabs are medical devices and must be included in the ARTG
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FormsInformation and links to the medical devices priority applicant determination application form.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/QWP/159/96 corr.
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FormsFind out what process to follow if a product is manufactured using a human embryo or a human embryonic stem cell, or any material sourced from such an embryo or stem cell.