We are aware of an issue causing the title of some ARTG entries to disappear. We are investigating as a priority and hope to have this resolved as soon as possible.
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623 result(s) found, displaying 51 to 75
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH Q5D; CPMP/ICH/294/95
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH Q6A; CPMP/ICH/367/96
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH Q6B; CPMP/ICH/365/96
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/EWP/567/98
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/SWP/81714/2010
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH Q5B; CPMP/ICH/139/95
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/QWP/811210/2009-Rev1
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CHMP/437/04 Rev 1
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User guideThis user guide is for sponsors applying for a variation to the Australian Register of Therapeutic Goods (ARTG) entry of a medical device or IVD medical device.
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Reference materialThe permitted indication reform has now commenced
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/HMPC/201116/2005 Rev. 2; EMA/CVMP/814/00 Rev.2; EMA/HMPC/201116/2005 Rev.2
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH Q5A(R1); CPMP/ICH/295/95
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/CVMP/QWP/199250/2009 corr
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Reference materialThe TGA has published guidance material on the TGA efficacy claim
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/CPMP/4548/03/Final/Rev 1
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/CHMP/PEG/194810/2005
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - 3BR3a
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FormsA form for sponsors to notify the TGA of the date that they will commence marketing a product registered on the ARTG
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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/CVMP/QWP/63699/2014.
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Reference materialThis guidance describes options for the removal of the Product Information (PI) as an insert from a medicine package while still complying with the labelling order.
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User guideThe system now allows equivalents in extracts or preparations of propolis and royal jelly to be correctly entered in the ARTG
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Reference materialThis guidance intends to outline for sponsors and manufacturers the types of RWE relevant in the Australian context.
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FormsMedicine safety issue notification form for sponsors