Therapeutic goods orders

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, 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
• Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines
  • Guidance for TGO 91 and TGO 92
• Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017
  • 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.
    • GMP for Medicinal Products Introduction
    • GMP for Medicinal Products Part I
    • GMP for Medicinal Products Part II
    • GMP for Medicinal Products Annexes
• Therapeutic Goods Order No. 94 (Standard for Haematopoietic Progenitor Cells derived from Cord Blood)
• Therapeutic Goods Order No. 95 - Child-resistant packaging requirements for medicines 2017 (TGO 95)
  • Child-resistant packaging requirements for medicines - Guidance on TGO 95
• Therapeutic Goods Order No. 99 - Therapeutic Goods (Standard for Menstrual Cups) Order 2018
• Therapeutic Goods Order No. 100 - Therapeutic Goods (Microbiological Standards for Medicines) Order 2018
• Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019
  • Guidance for TGO 101: Standard for tablets, capsules and pills
• Therapeutic Goods (Standard for Blood and Blood Components) (TGO 102) Order 2019
• Therapeutic Goods (Standards for Tampons) (TGO 103) Order 2019
• Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Order 2019
• Therapeutic Goods (Standard for Faecal Microbiota Transplant Products) (TGO 105) Order 2020
  • Guidance for TGO 105: Standards for faecal microbiota transplant (FMT) products
• Therapeutic Goods (Medicines - Standard for Serialisation and Data Matrix Codes) (TGO 106) Order 2021
  • Standard for serialisation and data matrix codes on medicines: Guidance for TGO 106
• Therapeutic Goods (Standard for Biologicals - Labelling Requirements) (TGO 107) Order 2021
  • Guidance on TGO 107 - Standard for Biologicals - Labelling Requirements
  • Clause-by-clause tracking TGO 107 from TGO87
• Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Sreeening Requirements) (TGO 108) Order 2021
  • Guidance on TGO 108 - Standard for Human Cell and Tissue Products - Donor Screening Requirements (Version 2 - Post consultation)
  • Clause-by-clause tracking TGO 108 from TGO88
• Therapeutic Goods (Standards for Biologicals-General and Specific Requirements) (TGO 109) Order 2021
  • Guidance for TGO 109 - for Biologicals-General and Specific Requirements
  • Clause-by-clause tracking TGO 109 from TGO83 to TGO88
• Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110) Order 2021
  • Nicotine vaping products and vaping devices: Guidance for TGO 110 and related matters
• Therapeutic Goods (Standard for Human Albumin) (TGO 111) Order 2022- external site
• Therapeutic Goods (Standard for MDMA) (TGO 112) Order 2024
• Therapeutic Goods (Standard for Psilocybine) (TGO 113) Order 2024
• Therapeutic Goods (Standard for Export Only Medicines) (TGO 114) Order 2024

Recently repealed or sunsetted instruments

Once legislation has done its work or is no longer required it is usually repealed. Repealing redundant legislation 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
• Therapeutic Goods Order No. 34 - Standard for Diagnostic Goods of Human Origin
• Therapeutic Goods Order No. 37 - General Requirements for Labels for Therapeutic Devices
• Therapeutic Goods Order No. 41 - Single-use syringes (sterile) for the injection of 100 units per millilitre insulin (U-100)
• Therapeutic Goods Order No. 46 - Standards for Potassium Chloride, Hydrocortisone Acetate Cream and Hydrocortisone Acetate Ointment
• Therapeutic Goods Order No. 49 - General Standard for Sutures
• Therapeutic Goods Order No. 50 - General Standard for Pyrogen and Endotoxin Content of Therapeutic Goods
• Therapeutic Goods Order No. 52 - Examination Gloves for General Medical and Dental Use
• Therapeutic Goods Order No. 53 - Single-use Sterile Surgical Rubber Gloves
• Therapeutic Goods Order No. 54 - Standard for Disinfectants and Sterilants (as amended)
• Therapeutic Goods Order No. 54A - Amendment to Therapeutic Goods Order No. 54 - Standard for Disinfectants and Sterilants
• Therapeutic Goods Order No. 54B - Amendment to Therapeutic Goods Order No. 54 - Standard for Disinfectants and Sterilants
• Therapeutic Goods Order No. 59 - Polymer Urethral Catheters for General Medical Use
• Therapeutic Goods Order No. 61A - Contraceptive Devices - Rubber Condoms
• Therapeutic Goods Order No. 63 - Standard for Sterile Therapeutic Goods
• Therapeutic Goods Order No. 67 - Standard for Dental Materials
• Therapeutic Goods Order No. 67A - Amendment to Therapeutic Goods Order No. 67 - Standard for Dental Materials
• Therapeutic Goods Order No. 68 - Standard for Plasticized Polyvinyl Chloride (PVC) Blood Bags
• Therapeutic Goods Order No. 69 - General requirements for labels for medicines 2017
• Therapeutic Goods Order No. 69A - Amendment to Therapeutic Goods Order No. 69 - General requirements for labels for medicines
• Therapeutic Goods Order No. 69B - Amendment to Therapeutic Goods Order No. 69 - General requirements for labels for medicines
• Therapeutic Goods Order No. 69C - Amendment to Therapeutic Goods Order No. 69 - General requirements for labels for medicines
• Therapeutic Goods Order No. 70B - Standards for Export Only Medicine
• Therapeutic Goods Order No. 70C – Standards for Export Only Medicine
• Therapeutic Goods Order No. 76 - Revocation of Therapeutic Goods Orders
• Therapeutic Goods Order No. 77 - Microbiological Standards for Medicines
• Therapeutic Goods Order No. 78 - Standard for Tablets and Capsules
• Therapeutic Goods Order No. 80 - Child-Resistant Packaging Requirements for Medicines
• Therapeutic Goods Order No. 80A - Amendments to Therapeutic Goods Order No. 80 Child-Resistant Packaging Requirements for Medicines
• Therapeutic Goods Order No. 81 - Standards for Blood and Blood Components
• Therapeutic Goods Order No. 82 - Standard for Tampons - Menstrual
• Therapeutic Goods Order No. 83 - Standards for human musculoskeletal tissue
• Therapeutic Goods Order No. 84 - Standards for human cardiovascular tissue
• Therapeutic Goods Order No. 85 - Standards for human ocular tissue
• Therapeutic Goods Order No. 86 - Standards for human skin
• Therapeutic Goods Order No. 87 - General requirements for the labelling of biologicals
• 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
• Therapeutic Goods Order No. 89 - Standard for Water for Injections for Parenteral Medicines
• Therapeutic Goods Order No. 90 - Standard for Human Albumin