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629 result(s) found, displaying 476 to 500
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/EWP/239/95 Rev. 1, Corr.1*
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/BWP/310834/2012 Rev. 1
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/BWP/2490/00.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - Considerations for the use of real-world data and real-world evidence to support regulatory decision-making for drug and biological products.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CVMP/QWP/907965/2022
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/BWP/548524/2008 rev 1
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/291450/2018
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/291499/2018
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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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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/CVMP/QWP/850374/2015
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/EWP/280/96 Corr 1
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/QWP/159/96 corr.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/760125/2016.
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ICH Topic E 2 A – Clinical safety data management: definitions and standards for expedited reporting
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline with annotations – ICH E2A; CPMP/ICH/377/95 -
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/CHMP/BMWP/118264/2007 Rev. 1.
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FormsApplication for consent to supply goods that do not conform with subsection 9(2) of TGO No. 92 - Standard for labels of non-prescription medicines - section 14/14A
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User guideA user guide for applicants using the TGA Business services (TBS) portal to complete an online application form for a new substance application.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH E14; CHMP/ICH/2/04
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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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FormsUse this form to request 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 - EMEA/CHMP/BMWP/301636/2008 Rev. 1.
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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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FormsUse this form for Category 1 and Comparable Overseas Regulator (COR) report-based prescription medicines applications, or variations.
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FormsUse these forms to apply for a permit to export human substances from Australia
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Compositional guidelinesCompositional guideline for 'Steviol glycosides' permitted for use in listed medicines