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623 result(s) found, displaying 126 to 150
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH E7; CPMP/ICH/379/95
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Reference materialCase studies can provide advertisers with valuable insight to how the TGA uses enforcement tools to address non-compliant advertising of therapeutic goods
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/BWP/532517/2008.
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FormsTemplates to help you with your communications under the Uniform recall procedure for therapeutic goods (URPTG).
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Reference materialThis guidance helps sponsors and manufacturers of therapeutic goods to understand and use the Poisons Standard to determine if any restrictions apply to their product
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Reference materialImportant information on the Database of TGA Laboratory testing results.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/351466/2012
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Reference materialThe Annual Charge Exemption (ACE) declaration period occurs between 1 July and 22 July.
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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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User guideCheck out our user guide to assist sponsors when using the code tables for GMP Clearance applications.
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FormsNew features have been launched for the Medical Devices Consent for Non-compliance Dashboard in TBS Business Services Portal
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Reference materialSurgical mesh device supply disruption guidance for doctors and hospitals.
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FormsApplication form to apply for biologicals (priority applicant) determination
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User guideThis user guide is for sponsors applying to change the entry in the ARTG for a registered non-prescription over-the-counter (OTC) medicine
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH E5(R1); CPMP/ICH/289/95
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/BWP/2490/00.
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Guideline on quality aspects on the isolation of candidate influenza vaccine viruses in cell culture
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/BWP/368186/2011 -
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/CVMP/SWP/169430/2012
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/BWP/214/96
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/CVMP/SWP/246844/2018
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/CHMP/SWP/1991104/2014 corr 1
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH Q9; EMA/CHMP/ICH/24235/2006
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH S2 (R1); EMA/CHMP/ICH/126642/2008
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH S6 (R1); EMA/CHMP/ICH/731268/1998