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Therapeutic goods orders

12 March 2013

If you intend to rely on any legislation referred to on this website, you should access copies of the official versions on the Attorney-General's ComLaw website, which incorporates the Federal Register of Legislative Instruments (FRLI). 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 consultation with the Therapeutic Goods Committee. Prior to this the TGOs were approved under various sections of the Therapeutic Goods Act 1966.

Current TGOs

• 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
• 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. 75 - Standard for Haematopoietic Progenitor Cells Derived from Cord Blood
• 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. 89 - Standard for Water for Injections for Parenteral Medicines
• Therapeutic Goods Order No. 90 - Standard for Human Albumin

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TGO guidance

• Supplementary Notes on Therapeutic Goods Order No. 69 - General requirements for labels for medicines
  The supplementary notes are intended to explain parts of the Order and are not part of the Order

• Explanatory notes for Therapeutic Goods Order No. 34 Standard for Diagnostic Goods of Human Origin
  Explanatory notes for Therapeutic Goods Order No. 34 Standard for Diagnostic Goods of Human Origin
• Guidance on Therapeutic Goods Order No. 77 Microbiological standards for medicines
  Plain English explanation of various requirements of Therapeutic Goods Order No. 77 Microbiological Standards for Medicines (TGO 77) and their application
• Guidance on Therapeutic Goods Order No. 78 Standard for tablets and capsules
  Plain English explanation of various requirements of Therapeutic Goods Order No. 78 Standard for Tablets and Capsules (TGO 78) and their application
• Guidance on Therapeutic Goods Order No. 80 Child-resistant packaging requirements for medicines
  Plain English explanation of various requirements of Therapeutic Goods Order No. 80 Child-Resistant Packaging requirements for Medicines (TGO 80)

• Guidance on TGOs 83, 84, 85, 86 and 87 is available as appendices of the Australian Regulatory Guidelines for Biologicals (ARGB)