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629 result(s) found, displaying 101 to 125
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User guideThe Special Access Scheme (SAS) & Authorised Prescriber (AP) Online System (SAS & AP online system) is the preferred method of submission for AP applications.
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FormsSuspected adverse events that occur after having a vaccination can be reported to the TGA
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/302620/2017.
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FormsApply for a Certificate of Free Sale or an Export Certificate for a medical device.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/507988/2013 (annex).
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User guideInformation on how to compile a literature based submission (including mixed applications).
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/EWP/QWP/1401/98 Rev. 1/Corr **
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FormsInformation and links to the medical devices priority applicant determination application form.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICHER(R1); EMA/CHMP/ICH/436221/2017
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User guideHow to withdraw your Australian Register of Therapeutic Goods (ARTG) application, for medical device sponsors (includes importers and exporters).
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FormsThe Registered medicine variation form (complementary medicines) should only be used when you wish to vary the particulars of complementary medicines which are already registered in the ARTG.
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FormsTemplates to help you with your communications under the Procedure for Recalls, Product Alerts and Product Corrections (PRAC).
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International scientific guidelines adopted in AustraliaEMA/HMPC/CHMP/CVMP/162241/2005 Rev. 3 adopted by the Therapeutic Goods Administration (TGA)
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FormsSponsors should note that the Bioequivalence Study Information Form (BSIF) has been amended
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FormsInformation and forms about applications for TGA Conformity Assessment certificates.
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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 - CPMP/SWP/2877/00
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FormsThis form is to assist users of the Electronic Lodgement Facility (ELF) seeking preclearance for animal derived ingredients by detailing what the TGA is looking for and what supporting documents need to be provided.
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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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FormsYou must submit this notification to the TGA to qualify as a transitional manufacturer and be exempt, between 1 January 2024 and 1 December 2024, from the requirement to hold a manufacturing licence for therapeutic vaping goods.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/BWP/706271/2010
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - 3CC3A
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/EWP/2747/00
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/QWP/2934/99
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/56793/2014