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629 result(s) found, displaying 451 to 475
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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/CHMP/205/95 Rev.6
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - Real-World Data/Real-World Evidence (RWD/RWE)
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - WHO Technical Report Series, No. 927, 2005
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline- WHO Technical Report Series No. 987, 2014
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH E12; CPMP/ICH/541/00
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/EWP/4151/00 Rev.1
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ChecklistsA checklist to help medical device manufacturers demonstrate compliance with the Essential Principles.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CHMP/BPWP/410415/2011 Rev 1
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FormsForm to apply to add an export name to a product registered in the ARTG.
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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 - EMEA/CHMP/BMWP/94528/2005 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 - 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/CHMP/325170/2012.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/703715/2012 Rev.2.
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User guideThe user guide for the Clinical Trial Notification (CTN) form has been updated to reflect the recent updates to the online CTN form.
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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 guideInstructions for applicants on how to organise and fill out a pre-submission planning form (PPF).
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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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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.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/735037/2015 Rev.1