The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
Guidance
Our Guidance explains the laws and regulations governing the development, manufacturing, marketing, and supply of therapeutic goods in Australia.
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23 result(s) found, displaying 1 to 23
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GuidanceGuidance on the regulatory requirements for assessed listed medicines.
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GuidanceGuidance providing an overview of listed medicines and listed assessed medicines pathways and legislative requirements.
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GuidanceThese requirements apply to applications for the addition of new ingredients, or variation of existing ingredients, as listed in the Permissible Ingredients Determination, that are lodged with the TGA from 1 February 2023.
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GuidanceGuidance about the administrative information to support assessed listed medicine applications.
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GuidanceGuidance for using the 'TGA assessed' claim on labels for assessed listed medicines and registered complementary medicines.
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GuidanceGuidance for data requirements for microorganisms used as active ingredients in listed or registered complementary medicines. These are generally referred to as probiotics or postbiotics.
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GuidanceGuidance on the format requirements for dossiers. Amendments to Part C to update the reference for dossier requirements for biologicals.
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GuidanceGuidance on using reports from COBs and submission requirements for evaluation of these applications.
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GuidanceAn overview of the Data Protection Scheme for assessed listed medicines, and the criteria that must be met for information to be considered protected under the Scheme.
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GuidanceGuidance for industry organisations applying to add a medicine to the Australian Register of Therapeutic Goods (ARTG).
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GuidanceGuidance on our approved terminology for medicines.
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GuidanceThis guidance will help you understand our pharmacovigilance inspection program (PVIP).
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GuidanceGuidance on using literature based submissions for applications for listed, assessed listed and registered complementary medicines.
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GuidanceGuidance on the application process and information required for a substance to be evaluated for use in listed medicines.
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GuidanceGuidance explaining how the Comparable Overseas Bodies report-based process is associated with shortened evaluation timeframes for applications.
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GuidanceInformation that must be submitted in order for an application to list an assessed listed medicine in the Australian Register of Therapeutic Goods (ARTG).
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GuidanceGuidance for interpreting the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to good manufacturing practice (GMP) for medicinal products.
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GuidanceGuidance on changing information in the ARTG for listed or assessed listed medicines.
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GuidanceGuidance for interpreting the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to good manufacturing practice (GMP) for medicinal products.
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GuidanceGuidance for interpreting the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to good manufacturing practice (GMP) for medicinal products.
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GuidanceGuidance for providing acceptable evidence to support indications and claims made about your listed medicine.
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GuidanceGuidance on how to access and use the Permissible Ingredients Determination for the purposes of submitting applications for substances in listed and assessed listed medicines.
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GuidanceInformation required to establish quality for listed medicines