Resources
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630 result(s) found, displaying 26 to 50
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User guideUser guide for sponsors converting their dossier format from paper, CTD or NeeS to eCTD
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User guideUser guide for sponsors who need to withdraw information from their eCTD dossiers and can be used as best practice for NeeS withdrawals
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User guideSponsor user guide updated to include final report and additional information requirements following amendments to the Therapeutic Goods (Medical Devices) Regulations 2002.
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FormsThis form is used by sponsors of exempt therapeutic goods to inform the TGA of the details of the supply of such goods on a quarterly basis, as required by item 5 of Schedule 5A to the Therapeutic Goods Regulations 1990.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/PRAC/222346/2014
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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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FormsA revised CPD template for Biological medicines and vaccines is now available for sponsors
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FormsThis form is for sponsors to report Significant Safety Issues (SSIs) and Urgent Safety Measures (USMs) to the TGA.
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User guideUser guide on how to submit shortage/discontinuation notifications to the TGA
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/426390/2021
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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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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/EWP/239/95 Rev. 1, Corr.1*
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FormsCertified product details (CPD) - Chemical prescription medicines
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User guideHow to successfully complete and submit an application for consent to import, supply, or export medical devices that do not meet the Essential Principles.
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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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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/VWP/457259/2014
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User guideThis user guide is for sponsors applying to change the entry in the ARTG for a registered non-prescription OTC medicine.
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FormsUse these forms to request a meeting and to record agenda items and outcomes.
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User guideThis document is for Australian sponsors and manufacturers of sterile medicines and active pharmaceutical ingredients (APIs) made or supplied in Australia.
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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 - EMA/CAT/80183/2014
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User guideA guide for using the TGA Business services (TBS) portal for listed and assessed listed medicine applications.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/EWP/239/95 final
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User guideCheck out our user guide to assist sponsors when using the code tables for GMP Clearance applications.