Guidance
Our Guidance explains the laws and regulations governing the development, manufacturing, marketing, and supply of therapeutic goods in Australia.
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317 result(s) found, displaying 126 to 150
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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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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 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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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 for industry organisations applying to add a medicine to the Australian Register of Therapeutic Goods (ARTG).
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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 will help you understand our pharmacovigilance inspection program (PVIP).
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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).
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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 for making an offer of enforceable undertaking to us.
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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 for sponsors about how to apply for orphan drug designation for a prescription medicine.
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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 requirements for Australian market authorisation of preparations containing bromhexine hydrochloride, for an OTC new medicine N2 application.
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GuidanceGuidance to understand if your medical device product should be in the Australian Register of Therapeutic Goods (ARTG).