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889 result(s) found, displaying 701 to 725
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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 - EMA/INS/GCP/856758/2018
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Reference materialThe Australian Regulatory Guidelines for Prescription Medicines (ARGPM) assist applicants and sponsors to register new prescription medicines or vary existing registrations in Australia.
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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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Reference materialoverview of identification of herbal materials and extracts
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Reference materialImproved CMI templates and resources
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Reference materialThis infographic is a printable resource that can be used to communicate the streamlined approval process for medical practitioners.
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Reference materialInfographic provides an overview of consumer access to medicinal cannabis in Australia
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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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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - ICH E6 (R2) Integrated Addendum
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International scientific guidelines adopted in AustraliaEMEA/CHMP/EWP/192217/2009 adopted by the Therapeutic Goods Administration (TGA)
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International scientific guidelines adopted in AustraliaEMEA/CPMP/VEG/4717/2003 Rev.1 adopted by the Therapeutic Goods Administration (TGA)
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International scientific guidelines adopted in AustraliaEMA/CHMP/BWP/310834/2012 Rev. 1 adopted by the Therapeutic Goods Administration (TGA)
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International scientific guidelines adopted in AustraliaCHMP/VWP/263499/06 adopted by the Therapeutic Goods Administration (TGA)
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International scientific guidelines adopted in AustraliaEMA/CHMP/BWP/368186/2011 adopted by the Therapeutic Goods Administration (TGA)
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International scientific guidelines adopted in AustraliaCPMP/EWP/QWP/1401/98 adopted by the Therapeutic Goods Administration (TGA)
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International scientific guidelines adopted in AustraliaCPMP/BWP/214/96 adopted by the Therapeutic Goods Administration (TGA)
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International scientific guidelines adopted in AustraliaCHMP/ICH/405290/2010 adopted by the Therapeutic Goods Administration (TGA)
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International scientific guidelines adopted in AustraliaEMA/CHMP/ICH/561176/2007 adopted by the Therapeutic Goods Administration (TGA)
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International scientific guidelines adopted in AustraliaEMA/CHMP/ICH/308671/2008 adopted by the Therapeutic Goods Administration (TGA)
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International scientific guidelines adopted in AustraliaEMA/CHMP/ICH/308867/2008 adopted by the Therapeutic Goods Administration (TGA)
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International scientific guidelines adopted in AustraliaEMA/CHMP/ICH/308895/2008 adopted by the Therapeutic Goods Administration (TGA)
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International scientific guidelines adopted in AustraliaCHMP/ICH/645408/2008 adopted by the Therapeutic Goods Administration (TGA)