Guidance
Our Guidance explains the laws and regulations governing the development, manufacturing, marketing, and supply of therapeutic goods in Australia.
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311 result(s) found, displaying 101 to 125
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GuidanceGuidance about how to make variations to Australian Register of Therapeutic Goods (ARTG) entries for prescription medicines.
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GuidanceGuidance to change an OTC medicine, listed in the Australian Register of Therapeutic Goods (ARTG), using the Changes Table.
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GuidanceGuidance on the regulation of system or procedure packs and using the special conformity assessment procedure.
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GuidanceGuidance for manufacturers outlining the procedures for submitting Conformity Assessments and declarations of conformity for in-vitro diagnostic devices (IVDs)
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GuidanceGuidance on TGO 108: Requirements around the minimisation of transmission of communicable diseases for therapeutic goods containing biologicals and human cell or tissue (HCT).
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GuidanceGuidance on TGO 109: Standards for Biologicals - General and Specific Requirements.
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GuidanceThis guidance is for manufacturers of registered medicinal gases to understand our interpretation of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to GMP for medicinal products.
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GuidanceInformation to help sponsors and manufacturers decide if antiviral‑claim products need ARTG entry to be imported or supplied in Australia.
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GuidanceGuidance on using reports from COBs and submission requirements for evaluation of these applications.
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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 to help manufacturers of medical devices classify their devices correctly.
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GuidanceGuidance for supplying substitute medicines when registered medicines are unavailable or in short supply.
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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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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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GuidanceThis guidance will assist companies making announcements, to comply with their continuous disclosure obligations, without advertising therapeutic goods to the public.
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GuidanceGuidance on the clinical evidence requirements for medical devices, including in-vitro diagnostic medical devices (IVDs), under Australian legislation.
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GuidanceGuidance about the types of notifications and variations for chemically derived (non-biological) prescription medicines.
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GuidanceGuidance about the types of notifications and variations for biological medicines.
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GuidanceGuidance on how to comply with the quality standards for MDMA (TGO 112) and psilocybine (TGO 113).
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GuidanceGuidance for sponsors on the process for including IVD medical devices in the ARTG.
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GuidanceGuidance on reclassifying active medical devices with diagnostic functions in Australia, including transition arrangements, Class III requirements, and sponsor obligations for ARTG inclusion.
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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 explains requirements for registering a non-prescription OTC medicine on the Australian Register of Therapeutic Goods (ARTG).
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GuidanceGuidance to understand the quality requirements of Therapeutic Goods Order No. 101 - Standard for tablets, capsules and pills (TGO 101, the Order).