Australia

CountryGuideline nameKeywordsLink
AustraliaTherapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines https://www.legislation.gov.au/Details/F2023C00458
AustraliaTherapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines https://www.legislation.gov.au/Details/F2023C00456
AustraliaTherapeutic Goods Order No. 95 – Child‑resistant packaging requirements for medicines 2017 https://www.legislation.gov.au/Details/F2017L01577
AustraliaTherapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110) Order 2021 https://www.legislation.gov.au/Details/F2021L00595
AustraliaTherapeutic Goods (Medicines—Standard for Serialisation and Data Matrix Codes) (TGO 106) Order 2021 https://www.legislation.gov.au/Details/F2021L00333
AustraliaTherapeutic Goods (Medicines Advisory Statements) Specification 2021 https://www.legislation.gov.au/Details/F2021L01888
AustraliaRequirements for OTC new medicines N2 applications (using OTC medicine monographs) https://www.tga.gov.au/requirements-otc-new-medicines-n2-applications-using-otc-medicine-monographs
AustraliaARGOM Appendix 2: Guidelines on quality aspects of OTC applications 8. Finished product container https://www.tga.gov.au/resources/resource/guidance/argom-appendix-2-guidelines-quality-aspects-otc-applications/8-finished-product-container
AustraliaWhat’s on my medicine label? https://www.tga.gov.au/products/medicines/find-information-about-medicine/whats-my-medicine-label
AustraliaInhalation and nasal spray registered medicines https://www.tga.gov.au/resources/resource/guidance/inhalation-and-nasal-spray-registered-medicines
AustraliaCode of practice for tamper-evident packaging of therapeutic goods https://www.tga.gov.au/resources/resource/guidance/code-practice-tamper-evident-packaging-therapeutic-goods
AustraliaChild-resistant packaging requirements for medicines – Guidance on TGO 95 https://www.tga.gov.au/resources/resource/guidance/child-resistant-packaging-requirements-medicines-guidance-tgo-95
AustraliaBiologicals packaged or combined with another therapeutic good https://www.tga.gov.au/resources/resource/guidance/biologicals-packaged-or-combined-another-therapeutic-good
AustraliaInternational scientific guideline: Guideline on plastic immediate packaging materials https://www.tga.gov.au/resources/resource/international-scientific-guidelines/international-scientific-guideline-guideline-plastic-immediate-packaging-materials
AustraliaInternational scientific guideline: ICH topic Q 1 F – Note for guidance on stability data package for registration in climatic zones III and IV https://www.tga.gov.au/resources/resource/international-scientific-guidelines/international-scientific-guideline-ich-topic-q-1-f-note-guidance-stability-data-package-registration-climatic-zones-iii-and-iv
AustraliaSupplier assessment, approval and qualification for listed and complementary medicines https://www.tga.gov.au/resources/resource/guidance/supplier-assessment-approval-and-qualification-listed-and-complementary-medicines
AustraliaStandard for serialisation and data matrix codes on medicines https://www.tga.gov.au/resources/resource/guidance/standard-serialisation-and-data-matrix-codes-medicines
AustraliaNicotine vaping products and vaping devices https://www.tga.gov.au/resources/resource/guidance/nicotine-vaping-products-and-vaping-devices
AustraliaSampling and testing for listed and complementary medicines https://www.tga.gov.au/resources/resource/guidance/sampling-and-testing-listed-and-complementary-medicines
AustraliaNational guideline for retail storage of Schedule 6 and Schedule 7 poisons https://www.tga.gov.au/resources/resource/guidance/national-guideline-retail-storage-schedule-6-and-schedule-7-poisons
AustraliaMedical device labelling obligations https://www.tga.gov.au/resources/resource/guidance/medical-device-labelling-obligations
AustraliaTips on creating prescription medicine labels compliant with TGO 91 https://www.tga.gov.au/resources/resource/guidance/tips-creating-prescription-medicine-labels-compliant-tgo-91
AustraliaWarnings on labels of medicines containing neuromuscular blocking agents https://www.tga.gov.au/resources/resource/guidance/warnings-labels-medicines-containing-neuromuscular-blocking-agents
AustraliaARGOM Appendix 3: Guidelines on presentation aspects of OTC applications https://www.tga.gov.au/resources/resource/guidance/argom-appendix-3-guidelines-presentation-aspects-otc-applications
AustraliaGuidance on the regulation of menstrual cups in Australia https://www.tga.gov.au/resources/resource/guidance/guidance-regulation-menstrual-cups-australia
AustraliaVariations to prescription medicines – excluding variations requiring evaluation of clinical or bioequivalence data, Appendix 2: Variation types – biological medicines https://www.tga.gov.au/resources/resource/guidance/variations-prescription-medicines-excluding-variations-requiring-evaluation-clinical-or-bioequivalence-data-appendix-2-variation-types-biological-medicines
AustraliaOngoing stability testing for listed and complementary medicines https://www.tga.gov.au/resources/resource/guidance/ongoing-stability-testing-listed-and-complementary-medicines
AustraliaReleasing medicines manufactured at multiple sites https://www.tga.gov.au/resources/resource/guidance/releasing-medicines-manufactured-multiple-sites
AustraliaGuidance on the regulation of tampons in Australia https://www.tga.gov.au/resources/resource/guidance/guidance-regulation-tampons-australia
AustraliaMedicinal cannabis manufacture https://www.tga.gov.au/resources/resource/guidance/medicinal-cannabis-manufacture
AustraliaElectronic Instructions for Use – eIFU https://www.tga.gov.au/resources/resource/guidance/electronic-instructions-use-eifu
AustraliaGuidance on the regulation of exempt disinfectants in Australia https://www.tga.gov.au/resources/resource/guidance/guidance-regulation-exempt-disinfectants-australia
AustraliaMedicine labels: Guidance on TGO 91 and TGO 92 https://www.tga.gov.au/resources/resource/guidance/medicine-labels-guidance-tgo-91-and-tgo-92
AustraliaThe Poisons Standard and medical devices https://www.tga.gov.au/resources/resource/guidance/poisons-standard-and-medical-devices
AustraliaHand sanitisers: Information for manufacturers, suppliers and advertisers https://www.tga.gov.au/resources/resource/guidance/hand-sanitisers-information-manufacturers-suppliers-and-advertisers
AustraliaBoxed Warning guidance https://www.tga.gov.au/resources/resource/guidance/boxed-warning-guidance
AustraliaARGB Appendix 11 – Guidance on TGO 107: Standard for Biologicals – Labelling Requirements https://www.tga.gov.au/resources/resource/guidance/argb-appendix-11-guidance-tgo-107-standard-biologicals-labelling-requirements
AustraliaGuidelines for using the TGA assessed claim on medicine labels https://www.tga.gov.au/resources/resource/guidance/guidelines-using-tga-assessed-claim-medicine-labels
AustraliaWhat does ‘TGA assessed’ mean on my medicine label? https://www.tga.gov.au/resources/resource/guidance/what-does-tga-assessed-mean-my-medicine-label
AustraliaSampling of starting and packaging material (Annex 8) https://www.tga.gov.au/resources/resource/guidance/medicinal-cannabis-manufacture/sampling-starting-and-packaging-material-annex-8