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623 result(s) found, displaying 1 to 25
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FormsAs of 25 June 2024, use this PDF form to order Influenza Reagents.
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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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User guideUser guide for sponsors that provides the pilot specification and guidance information relevant for preparation of an electronic Common Technical Document (eCTD) sequence to the TGA.
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FormsUpdated form used to notify us of proprietary ingredient mixtures for use in therapeutic goods.
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User guideHow to successfully complete and submit an application for consent to import, supply, or export medical devices that do not meet the Essential Principles.
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ChecklistsThis checklist can help you assess if your advertising complies with legislative requirements.
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ChecklistsA compliance checklist for advertisers applying to use a restricted representation.
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User guideApply for our approval to use a restricted representation in advertising.
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User guideHow to view and respond to notifications related to an application for consent to import, supply, or export medical devices that do not meet the Essential Principles.
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FormsTemplates to help you with your communications under the Procedure for Recalls, Product Alerts and Product Corrections (PRAC).
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FormsThis form is used to nominate a new representative from your organisation to be the administrator
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Compositional guidelinesCompositional guideline for 'Steviol glycosides' permitted for use in listed medicines
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ChecklistsThis checklist summarises key obligations for psychiatrists applying to prescribe and access MDMA and psilocybine under the Authorised Prescriber scheme.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/BWP/303353/2010.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/189724/2018
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/CPMP/4548/03/Final/Rev 1
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH E3 Q&As (R1); EMA/CHMP/ICH/435606/2012
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/BWP/477/97
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/VWP/457259/2014
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - 3AB5.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/600958/2010/Corr.*
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/BPWG/1089/00
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH E2A; CPMP/ICH/377/95
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/40072/2010 Rev. 1.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/EWP/QWP/1401/98 Rev. 1/Corr **