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623 result(s) found, displaying 426 to 450
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Reference materialGuidance to assist sponsors and manufacturers comply with new regulations.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/BWP/3354/1999 rev.1
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Reference materialInformation on the different ways the Therapeutic Goods Administration (TGA) regulates disinfectants depending on the intended use and label claims.
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FormsUse this form to apply for an Australian Approved Name (AAN).
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International scientific guidelines adopted in AustraliaEMA/CHMP/494506/2012 (EMEA/CHMP/EWP/213057/2010) adopted by the Therapeutic Goods Administration (TGA)
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International scientific guidelines adopted in AustraliaCOMP/431/01 adopted by the Therapeutic Goods Administration (TGA)
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FormsYou must submit this notice before you import a cannabis vaping device or accessory.
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Reference materialGuidance on the use of permitted indications in Listed complementary medicines
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FormsForm to notify the TGA of the Exceptional Release of a non-conforming biological.
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FormsApplication form to import, supply or export a therapeutic good that does not comply with standards.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/BWP/271475/2006 rev.1
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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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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - ICH M8 Expert Working Group
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/41230/2015.
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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 - 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 - EMA/CHMP/325170/2012.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/239770/2014 Rev 2.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CHMP/51230/2013 Corr.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/BPWP/144552/2009 Rev. 1, Corr. 1.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/BWP/151897/2013
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/BWP/360642/2010 rev. 1
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Reference materialFrequently asked questions to further clarify the new regulatory framework for personalised medical devices
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Reference materialFrequently asked questions added