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889 result(s) found, displaying 326 to 350
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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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FormsUse this form when submitting an updated RMP after regulatory approval
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Reference materialUnderstanding the requirements of Section 11 of the Therapeutic Goods Advertising Code.
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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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Reference materialQuestions and answers about the Database of Adverse Event Notifications - Medicines
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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 materialYou can refine the results by date, product name and advanced search options and by interacting with the graphs and tables.
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FormsYou must complete and submit the relevant checklist as part of your dossier submission
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Reference materialA compositional guideline is a summary of descriptions, tests and limits that define the composition and characteristics of a substance approved for use in listed medicines as either an active substance or an excipient.
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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Reference materialThis guidance is no longer in use and has been replaced by ARGB Appendix 13 - Guidance on TGO 109: Standards for Biologicals-General and Specific Requirements.
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Reference materialThe standards have been remade and revised guidance published.
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FormsUpdated form used to notify the TGA of proprietary ingredient mixtures for use in therapeutic goods
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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 'Shea Butter Ethyl Esters' permitted for use in listed medicines
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Reference materialGuidance on the stages of preparing and submitting an application for inclusion of a Class 2, 3 or 4 biological in the ARTG
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Reference materialFind out how to use electronic or software-based medical devices safely.
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Compositional guidelinesCompositional guideline for 'Lipase' permitted for use in listed medicines
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Reference materialThe annual charge exemption (ACE) scheme is a self-declaration scheme
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Reference materialInformation on the different ways the Therapeutic Goods Administration (TGA) regulates disinfectants depending on the intended use and label claims.
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User guideNew feature added to the consent application form on TBS portal.
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User guideHow to view and respond to notifications related to an application for consent to import, supply, or export a medical device that does not comply with the Essential Principles (EPs).
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Reference materialInformation about what to include in the PI and CMI for products included in the Black Triangle Scheme.
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Reference materialTo enable timely distribution of COVID-19 treatments, international labels may be used during initial supply in Australia.
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FormsThis form collects information about the legal entity making applications under the Therapeutic Goods Act 1989.