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623 result(s) found, displaying 401 to 425
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FormsYou must submit this notification to the TGA to qualify as a transitional manufacturer and be exempt, between 1 January 2024 and 1 December 2024, from the requirement to hold a manufacturing licence for therapeutic vaping goods.
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User guideNew feature added to the consent application form on TBS portal.
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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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Reference materialThese case studies provide practical examples that demonstrate our guidance, legislation and policy in action.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CHMP/EWP/4279/02.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/185423/2010 Rev. 2.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/29947/2013/Rev. 4.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/748108/2013, Rev. 3.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/EWP/1080/00 Rev. 1.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CHMP/EWP/2454/02 corr.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/CPMP/555/95 Rev. 1.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/CHMP/BMWP/101695/2006.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/204715/2012 Rev 2.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/BMWP/86289/2010.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/QWP/1719/00 Rev 1.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/16274/2009.
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Guideline on the clinical investigation of recombinant and human plasma-derived factor VIII products
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/BPWP/144533/2009 rev 1) -
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/CHMP/BMWP/31329/2005.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/CHMP/EWP/321180/2008.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/EWP/1119/98/Rev. 1.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/CHMP/021/97 Rev. 1.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/QWP/1529/04.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - ICH M7 (R2); EMA/CHMP/ICH/83812/2013
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Guideline on clinical investigation of medicinal products for the treatment of chronic heart failure
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/EWP/235/95, Rev.2. -
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/QWP/428693/2013