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- Prescription medicines (291)
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Results for
"sponsor"
Search
619 result(s) found, displaying 276 to 300
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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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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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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 - EMA/CHMP/BWP/429241/2013
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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/CHMP/607022/2009
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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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ChecklistsA compliance checklist for advertisers applying to use a restricted representation.
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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 - 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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Reference materialThese historical guidelines describe the information to be supplied for the registration or listing of disinfectants and sterilants in the Australian Register of Therapeutic Goods (ARTG).
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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
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User guideElectronic data interchange for ICSR submission using the E2B R2 format
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User guideNotification form for lapses in medical device conformity assessment certification now available on the TGA Consultation Hub
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User guideUser guide for sponsors and manufacturers wanting to submit data in the NeeS 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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Reference materialThis guidance summarises the regulatory approach of the TGA for software based medical devices
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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 - CHMP/EWP/83561/2005.