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623 result(s) found, displaying 476 to 500
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CHMP/EWP/2922/01 Rev. 1
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/EWP/4284/02
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH Q11; EMA/CHMP/ICH/425213/2011
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH Q4B Annex 14; CHMP/ICH/529785/2010
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International scientific guidelines adopted in AustraliaCPMP/QWP/158/01 Revision, EMEA/CVMP/115/01 Revision adopted by the Therapeutic Goods Administration (TGA)
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FormsApply for a Certificate of Free Sale or an Export Certificate for a medical device.
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FormsThis checklist may help you to meet your responsibility for ensuring your advertising complies with the advertising legislative requirements.
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Reference materialStandards for donor selection, testing and minimising infectious disease transmission via therapeutic goods that are human blood and blood components, human tissues and human cellular therapy products
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CHMP/QWP/297/97 Rev 1 corr, EMEA/CVMP/1069/02
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Reference materialThis guide is for sponsors intending to use the priority review pathway for biologicals.
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Reference materialFind out how to use electronic or software-based medical devices safely.
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FormsUse this form to request for 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/BPWP/572810/2013.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/BPWP/94033/2007 rev. 2
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/INS/GCP/856758/2018
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH Q4B Annex 5; EMA/CHMP/ICH/308895/2008
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International scientific guidelines adopted in AustraliaEMEA/410/01 Rev 3 adopted by the Therapeutic Goods Administration (TGA)
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FormsUse this form to apply for an Approved Biological Name.
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Reference materialWatch this video for an overview of the TGA compliance framework
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Reference materialGuidance on the stages of preparing and submitting an application for inclusion of a Class 2, 3 or 4 biological in the ARTG
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Reference materialProvides an overview of therapeutic goods regulation, TGA's role and sponsor responsibilities when supplying therapeutic goods in Australia
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/838713/2011 Rev 2.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/CHMP/BMWP/301636/2008 Rev. 1.
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User guideThis is a step-by-step guide for agents and sponsors who wish to apply for Priority review, Provisional determination or Orphan drug designation of a prescription medicine.
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FormsUse this form for Category 1 and Comparable Overseas Regulator (COR) report-based prescription medicines applications, or variations.