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623 result(s) found, displaying 251 to 275
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/CHMP/313666/2005
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/BWP/CPMP/5136/03
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/536810/2008
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/CHMP/QWP/306970/2007
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/816292/2011 Rev 1.
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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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Reference materialImproved CMI templates and resources
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Reference materialUpdated guidance to reflect new amendments made to the regulations.
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FormsThis form is to be completed by the ingredient owner to authorise sponsors to use a protected ingredient that is the subject of an exclusivity period to list a medicine in the Register
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Reference materialRegulatory changes to importing, supplying and advertising nicotine vaping products
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User guideStep by step user guide on submitting applications to register a complementary medicine (RCM) or over the counter (OTC) medicine on the Australian Register of Therapeutic Goods (ARTG) in the TGA Business services (TBS).
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Reference materialThis information is intended for sponsors applying to the TGA to enter a radiopharmaceutical in the Australian Register of Therapeutic Goods (ARTG).
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/BWP/429241/2013
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/607022/2009
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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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Reference materialApply for access and manage your account details.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/CHMP/GTWP/125459/2006
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/CHMP/BWP/48316/2006
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/QWP/805880/2012 Rev. 2
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CHMP/BPWP/585257/2009
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/CPMP/EWP/2158/99
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CHMP/EWP/358650/2006 Corr 2
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/EWP/2284/99 Rev. 1