The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
If you intend to rely on any legislation referred to on this website, you should access copies of the official versions on the Federal Register of Legislation website - external site, which incorporates the Federal Register of Legislation (FRL). Instruments are amended from time to time and may, on occasions, be replaced or new instruments made.
Therapeutic goods must comply with various standards, which determine the consistency of product quality, including label quality. Many of these standards are international standards. However, sometimes it is necessary to specify an Australian standard, either for a particular type of therapeutic good or to specify particular labelling, packaging or other requirements. In these situations a Therapeutic Goods Order (TGO) is published.
Since 1992, TGOs have been approved by a delegate of the Minister under section 10 of the Therapeutic Goods Act 1989 after appropriate consultation. Prior to this the TGOs were approved under various sections of the Therapeutic Goods Act 1966.
Current TGOs
- Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines - external site
- Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines - external site
- Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017 - external site
- Guidance on quality requirements for medicinal cannabis products - Conforming with TGO 93
- The PIC/S Guide to GMP - The following PIC/S guide must be read in conjunction with Section 13 of the amended order above.
- Therapeutic Goods Order No. 94 (Standard for Haematopoietic Progenitor Cells derived from Cord Blood) - external site
- Therapeutic Goods Order No. 95 - Child-resistant packaging requirements for medicines 2017 (TGO 95) - external site
- Therapeutic Goods Order No. 99 - Therapeutic Goods (Standard for Menstrual Cups) Order 2018 - external site
- Therapeutic Goods Order No. 100 - Therapeutic Goods (Microbiological Standards for Medicines) Order 2018 - external site
- Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019 - external site
- Therapeutic Goods (Standard for Blood and Blood Components) (TGO 102) Order 2019 - external site
- Therapeutic Goods (Standards for Tampons) (TGO 103) Order 2019 - external site
- Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Order 2019 - external site
- Therapeutic Goods (Standard for Faecal Microbiota Transplant Products) (TGO 105) Order 2020 - external site
- Therapeutic Goods (Medicines - Standard for Serialisation and Data Matrix Codes) (TGO 106) Order 2021 - external site
- Therapeutic Goods (Standard for Biologicals - Labelling Requirements) (TGO 107) Order 2021 - external site
- Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Sreeening Requirements) (TGO 108) Order 2021 - external site
- Therapeutic Goods (Standards for Biologicals-General and Specific Requirements) (TGO 109) Order 2021 - external site
- Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110) Order 2021 - external site
- Therapeutic Goods (Standard for Human Albumin) (TGO 111) Order 2022- external site - external site
- Therapeutic Goods (Standard for MDMA) (TGO 112) Order 2024 - external site
- Therapeutic Goods (Standard for Psilocybine) (TGO 113) Order 2024 - external site
- Therapeutic Goods (Standard for Export Only Medicines) (TGO 114) Order 2024 - external site
Recently repealed or sunsetted instruments
Once legislation has done its work or is no longer required it is usually repealed. Repealing redundant legislation - external site also makes it easier to find and comply with in force law.
The following instruments have been repealed or allowed to sunset.
- Therapeutic Goods Order No. 28 - Standard for Contraceptive Devices - Diaphragms - external site
- Therapeutic Goods Order No. 34 - Standard for Diagnostic Goods of Human Origin - external site
- Therapeutic Goods Order No. 37 - General Requirements for Labels for Therapeutic Devices - external site
- Therapeutic Goods Order No. 41 - Single-use syringes (sterile) for the injection of 100 units per millilitre insulin (U-100) - external site
- Therapeutic Goods Order No. 46 - Standards for Potassium Chloride, Hydrocortisone Acetate Cream and Hydrocortisone Acetate Ointment - external site
- Therapeutic Goods Order No. 49 - General Standard for Sutures - external site
- Therapeutic Goods Order No. 50 - General Standard for Pyrogen and Endotoxin Content of Therapeutic Goods - external site
- Therapeutic Goods Order No. 52 - Examination Gloves for General Medical and Dental Use - external site
- Therapeutic Goods Order No. 53 - Single-use Sterile Surgical Rubber Gloves - external site
- Therapeutic Goods Order No. 54 - Standard for Disinfectants and Sterilants - external site (as amended)
- Therapeutic Goods Order No. 54A - Amendment to Therapeutic Goods Order No. 54 - Standard for Disinfectants and Sterilants - external site
- Therapeutic Goods Order No. 54B - Amendment to Therapeutic Goods Order No. 54 - Standard for Disinfectants and Sterilants - external site
- Therapeutic Goods Order No. 59 - Polymer Urethral Catheters for General Medical Use - external site
- Therapeutic Goods Order No. 61A - Contraceptive Devices - Rubber Condoms - external site
- Therapeutic Goods Order No. 63 - Standard for Sterile Therapeutic Goods - external site
- Therapeutic Goods Order No. 67 - Standard for Dental Materials - external site
- Therapeutic Goods Order No. 67A - Amendment to Therapeutic Goods Order No. 67 - Standard for Dental Materials - external site
- Therapeutic Goods Order No. 68 - Standard for Plasticized Polyvinyl Chloride (PVC) Blood Bags - external site
- Therapeutic Goods Order No. 69 - General requirements for labels for medicines 2017 - external site
- Therapeutic Goods Order No. 69A - Amendment to Therapeutic Goods Order No. 69 - General requirements for labels for medicines - external site
- Therapeutic Goods Order No. 69B - Amendment to Therapeutic Goods Order No. 69 - General requirements for labels for medicines - external site
- Therapeutic Goods Order No. 69C - Amendment to Therapeutic Goods Order No. 69 - General requirements for labels for medicines - external site
- Therapeutic Goods Order No. 70B - Standards for Export Only Medicine - external site
- Therapeutic Goods Order No. 70C – Standards for Export Only Medicine - external site
- Therapeutic Goods Order No. 76 - Revocation of Therapeutic Goods Orders - external site
- Therapeutic Goods Order No. 77 - Microbiological Standards for Medicines - external site
- Therapeutic Goods Order No. 78 - Standard for Tablets and Capsules - external site
- Therapeutic Goods Order No. 80 - Child-Resistant Packaging Requirements for Medicines - external site
- Therapeutic Goods Order No. 80A - Amendments to Therapeutic Goods Order No. 80 Child-Resistant Packaging Requirements for Medicines - external site
- Therapeutic Goods Order No. 81 - Standards for Blood and Blood Components - external site
- Therapeutic Goods Order No. 82 - Standard for Tampons - Menstrual - external site
- Therapeutic Goods Order No. 83 - Standards for human musculoskeletal tissue - external site
- Therapeutic Goods Order No. 84 - Standards for human cardiovascular tissue - external site
- Therapeutic Goods Order No. 85 - Standards for human ocular tissue - external site
- Therapeutic Goods Order No. 86 - Standards for human skin - external site
- Therapeutic Goods Order No. 87 - General requirements for the labelling of biologicals - external site
- Therapeutic Goods Order No. 88 - Standards for donor selection, testing, and minimising infectious disease transmission via therapeutic goods that are human blood and blood components, human tissues and human cellular therapy products - external site
- Therapeutic Goods Order No. 89 - Standard for Water for Injections for Parenteral Medicines - external site
- Therapeutic Goods Order No. 90 - Standard for Human Albumin - external site