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 176 to 200
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GuidanceGuidance to explain how the intended use of a biological product influences its classification and exemptions.
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GuidanceRelease on non-conforming biologicals is only permitted under prescribed circumstances and for an individual patient. Access to the request form and instructions are within the guidance document.
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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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GuidanceHow the TGA assesses the safety of materials derived from human and other animal species, naturally susceptible to TSE, that are used in the manufacture of therapeutic goods.
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GuidanceGuidance on clinical performance requirements and risk mitigation strategies.
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GuidanceGuidance on ARTG and Conformity Assessment requirements for immunohaematology reagents (IHRs).
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GuidanceGuidance about the regulation of sport supplements in Australia for importers and sellers.
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GuidanceGuidance on how to request early scientific advice on a biowaiver justification.
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GuidanceGuidance on changing information in the ARTG for listed or assessed listed medicines.
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GuidanceGuidance on medical device application processing timeframes.
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Accessing unapproved biologicals that are not on the Australian Register of Therapeutic Goods (ARTG)
GuidanceGuidance for people who want to access biologicals that are not included on the Australian Register of Therapeutic Goods (ARTG). -
GuidanceThis guidance is to assist health practitioners understand their requirements when prescribing ‘unapproved’ therapeutic goods for an individual patient using the Special Access Scheme (SAS).
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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 the quality and labelling requirements of Therapeutic Goods Legislation Amendment (Standard for Therapeutic Vaping Goods) (TGO 110) Instrument 2024.
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GuidanceHelps sponsors and manufacturers understand the 2024 quality and safety requirements for unapproved therapeutic vaping devices.
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GuidanceGuidance about how we regulate biologicals that are packaged, or combined, with other therapeutic goods.
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GuidanceGuidance on how to meet child-resistant packaging requirements in the Therapeutic Goods Order No. 95 - Child-resistant packaging requirements for medicines 2017 (TGO 95).
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GuidanceGuidance on how we make use of assessments from comparable overseas regulators (CORs).
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GuidanceGuidance for manufacturers of medical devices considering supplying the instructions for use of their device in an electronic or online format.
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GuidanceGuidance to help manufacturers and sponsors navigate packaging terms across the industry, to meet regulatory requirements.
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GuidanceThis guidance provides for a nationally uniform approach to retail storage of Schedule 6 and Schedule 7 poisons.
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GuidanceGuidance detailing self-certification procedures for Class I non-measuring, non-sterile non-IVD medical devices; Class 1 IVD medical devices; some systems and procedure packs; medical devices for export.
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GuidanceGuidance on clinical performance and risk mitigation requirements for self‑test IVDs for chlamydia, gonorrhoea and syphilis.
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GuidanceGuidance explaining how to find out which statements (if any) are required by the RASML for a particular over-the-counter (OTC) or complementary medicine.
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GuidanceGuidance on whether medicines are evaluated as prescription medicines or complementary or over-the-counter (OTC) medicines.