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726 result(s) found, displaying 426 to 450
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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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User guideUser guide on how to submit data in the electronic Common Technical Document (eCTD) format.
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FormsUse this form to request reinstatement of a cancelled entry on the Australian Register of Therapeutic Goods
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Compositional guidelinesCompositional guideline for 'Protease' permitted for use in listed medicines
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Reference materialFAQs for health professionals importing and supplying medical devices
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Reference materialHow the Therapeutic Goods Administration (TGA) defines and regulates listed disinfectants, including guidance on how to submit a product application and the supporting data and other information required.
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Compositional guidelinesCompositional guideline for 'Refined Buglossoides arvensis seed oil' permitted for use in listed medicines.
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Compositional guidelinesCompositional guidelines for 'Chicken Sternum Cartilage Powder' permitted for use in listed medicines.
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Reference materialOur approach to delays in overseas and Australian conformity assessment recertifications due to the COVID-19 pandemic and the implementation of the EU MDR/IVDR.
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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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Reference materialFrequently asked questions to further clarify the new regulatory framework for personalised medical devices
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Compositional guidelinesCompositional guideline for 'Galactooligosaccharides' permitted for use in listed medicines
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FormsApply to import and supply substitute medicines under section 19A
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User guideHow to use the ADR reporting template in the Best Practice software
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Compositional guidelinesCompositional guideline for 'Calanus finmarchicus oil' permitted for use in listed medicines
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FormsUse this form when submitting an updated RMP after regulatory approval
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FormsA form for sponsors to notify the TGA of the date that they will commence marketing a product registered on the ARTG
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FormsThe Pre-submission Planning Form (PPF) provides the TGA with the necessary information on the scope and scale of application to arrange appropriate resourcing for the processing and evaluation of an application.
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FormsYou must complete and submit the relevant checklist as part of your dossier submission
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Reference materialThe evaluation plan estimators can be used to approximate the dates of the milestones in the prescription medicine registration process
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Reference materialThis guidance is no longer in use and has been replaced by ARGB Appendix 13 - Guidance on TGO 109: Standards for Biologicals-General and Specific Requirements.
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Compositional guidelinesCompositional guideline for 'Shea Butter Ethyl Esters' permitted for use in listed medicines
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Compositional guidelinesCompositional guideline for 'Hemp Seed Oil' permitted for use in listed medicines
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Compositional guidelinesCompositional guideline for 'Lipase' permitted for use in listed medicines
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FormsThis form collects information about the legal entity making applications under the Therapeutic Goods Act 1989.