Resources
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670 result(s) found, displaying 1 to 25
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FormsThe application form to amend the current Poisons Standard.
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User guideUse this guide to prepare a cover letter for an over-the-counter (OTC) medicine application.
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Checklistschecklist that helps sponsors and manufacturers identify relevant industry standards and evidence needed to demonstrate compliance of medicinal cannabis vaping devices with the Essential Principles of Safety and Performance.
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User guideKnow how to submit data in the electronic Common Technical Document (eCTD) format for a non-prescription medicine application.
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FormsAccess TGA medical device Conformity Assessment application forms and guidance, including requirements for supporting data and certification.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/CHMP/SWP/28367/07 Rev. 1
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/QWP/245074/2015
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - ICH Q2 (R2); EMA/CHMP/ICH/82072/2006
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/BWP/133540/2017
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/539146/2013
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/802491/2018
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/BWP/534898/2008 rev. 2
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CVMP/QWP/709423/2022,Corr.1
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/257026/2018.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/CHMP/VWP/164653/05 Rev. 1
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/CHMP/VEG/134716/2004
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User guideLearn how to create and manage UDI records in the AusUDID online portal.
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FormsUse this form to request certificates or certified copies of TGA licences and certificates.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/ICH/24235/2006 Corr.2
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/HMPC/CHMP/CVMP/201116/2005 Rev. 3
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Compositional guidelinesCompositional guideline for Akkermansia muciniphila strain ATCC BAA-835 permitted for use in listed medicines.
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User guideHow to use the ADR reporting template in the Best Practice software
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ChecklistsThese checklist summarises key obligations for psychiatrists applying to prescribe and access MDMA and psilocybine under the Authorised Prescriber scheme.