Guidance
Our Guidance explains the laws and regulations governing the development, manufacturing, marketing, and supply of therapeutic goods in Australia.
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56 result(s) found, displaying 1 to 25
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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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GuidanceProvides Guidance on the regulatory requirements for labels and other medicine presentation.
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GuidanceUnderstand the regulatory requirements for supplying UDI compliant medical devices in Australia
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GuidanceTimeframes for supplying UDI compliant medical devices in Australia
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GuidanceThis Guidance describe the requirements and standards for sunscreens (and their ingredients), that we regulate as therapeutic goods in Australia
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GuidanceGuidance to help sponsors understand the potential overlap between certain foods, medicines, devices and cosmetics.
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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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GuidanceGuidance to assist sponsors and manufacturers comply with Therapeutic Goods (Microbiological standards for medicines) (TGO 100) Order 2018.
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GuidanceAustralian regulatory guidelines for over-the-counter medicines (ARGOM) Appendix 4.
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GuidanceAustralian regulatory guidelines for over-the-counter medicines (ARGOM) Appendix 3.
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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 to change an ARTG registered over-the-counter (OTC) medicine.
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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 about application pathways and data requirements for new generic medicines, and variations to existing medicines.
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GuidanceThis guidance will help you understand our pharmacovigilance inspection program (PVIP).
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GuidanceThis guidance explains requirements for registering a non-prescription over-the-counter (OTC) medicine on the Australian Register of Therapeutic Goods (ARTG).
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GuidanceGuidance on requirements for Australian market authorisation of preparations containing bromhexine hydrochloride, for an OTC new medicine N2 application.
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GuidanceGuidance on requirements for Australian market authorisation of topical nasal decongestant medicines, for an OTC new medicine N2 application.
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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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GuidanceGuidance on requirements for Australian market authorisation of tablets containing aspirin, for an OTC new medicine N2 application.
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