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Resources
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635 result(s) found, displaying 26 to 50
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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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User guideApply for our approval to use a restricted representation in advertising.
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User guideInformation on how to compile a literature based submission (including mixed applications).
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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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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/EWP/QWP/1401/98 Rev. 1/Corr **
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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 - 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 - 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 - EMA/CHMP/40072/2010 Rev. 1.
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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 - EMA/CHMP/600958/2010/Corr.*
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ICH Topic E 2 A – Clinical safety data management: definitions and standards for expedited reporting
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH E2A; CPMP/ICH/377/95 -
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - ICH M7 (R2); EMA/CHMP/ICH/5072766/2021
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FormsForm for sponsors to provide notice of Therapeutic vaping goods to Therapeutic Goods Administration
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FormsRequest cancellation of a therapeutic good on the Australian Register of Therapeutic Goods (ARTG)
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FormsInformation and forms about applications for TGA Conformity Assessment certificates.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/291571/2018
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/410/01 Rev. 3