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889 result(s) found, displaying 26 to 50
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Reference materialSurgical mesh device supply disruption guidance for doctors and hospitals.
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Reference materialGuidance to assist sponsors and manufacturers comply with new regulations.
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FormsAs of 25 June 2024, use this PDF form to order Influenza Reagents.
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FormsUse this form to make a freedom of information (FOI) request for a document held by the Therapeutic Goods Administration (TGA).
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User guideThe Special Access Scheme (SAS) & Authorised Prescriber (AP) scheme Online System (SAS & AP online system) is the preferred method of submission for SAS applications and notifications.
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Reference materialFind out more about product standards that apply to unapproved therapeutic vapes for smoking cessation and the management of nicotine dependence.
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Compositional guidelinesCompositional guideline for Akkermansia muciniphila strain ATCC BAA-835 permitted for use in listed medicines.
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User guideThis document applies to all regulatory activities in electronic Common Technical Document (eCTD) format.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/QWP/608924/2014
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH M3 (R2 ) Q&As; EMA/CHMP/ICH/507008/2011
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH M2(R2); EMA/CPMP/ICH/286/1995
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/CHMP/ICH/607698/2008
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FormsCTA applications are submitted using paper-based forms. There are two forms that must be completed by the sponsor.
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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 - EMEA/CHMP/BWP/298388/05
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/CHMP/BWP/298390/2005
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/CHMP/BWP/398498/2005
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/CHMP/CPWP/83508/2009
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/CHMP/ICH/449035/2009
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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 - ICH E14; EMA/CHMP/ICH/310133/2008
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH E2C (R2); EMA/CHMP/ICH/544553/1998
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH E3 Q&As (R1); EMA/CHMP/ICH/435606/2012
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - ICH E8 (R1); EMA/CHMP/ICH/544570/1998 Corr*
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH E3; CPMP/ICH/137/95