{"id":"F2017L00286","name":"Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017","slug":"therapeutic-goods-standard-for-medicinal-cannabis-tgo-93-order-2017","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":96000,"registerId":"commonwealth-F2017L00286-current","compilationNumber":null,"startDate":"2026-04-02","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Name of order","content":"#### 1 Name of order\n\nThis order is the Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017.","sortOrder":0},{"sectionNumber":"3","sectionType":"section","heading":"Authority","content":"#### 3 Authority\n\nThis order is made under subsection 10(1) of the Therapeutic Goods Act 1989.","sortOrder":1},{"sectionNumber":"4","sectionType":"section","heading":"Interpretation","content":"#### 4 Interpretation\n\nNote: A number of expressions used in this order are defined in subsection 3(1) of the Act, including the following:\n\n(a) batch;\n\n(b) British Pharmacopoeia;\n\n(c) container;\n\n(d) European Pharmacopoeia;\n\n(e) export only medicine;\n\n(f) label;\n\n(g) manufacture;\n\n(h) Register;\n\n(i) sponsor;\n\n(j) standard;\n\n(k) therapeutic goods;\n\n(l) United States Pharmacopeia–National Formulary.\n\n(1) In this order:\n\nacceptance criteria, in relation to microbiological quality, are interpreted as:\n\n(a) 101 CFU: maximum acceptable count is 20;\n\n(b) 102 CFU: maximum acceptable count is 200;\n\n(c) 103 CFU: maximum acceptable count is 2000, and so forth.\n\nAct means the Therapeutic Goods Act 1989.\n\nactive ingredient has the same meaning as in the Regulations.\n\nbatch number means a number, or a combination of numerals, symbols or letters, which is given by a manufacturer to a batch of a medicinal cannabis product, to uniquely identify that batch and from which it is possible to trace that batch through all stages of manufacture and distribution.\n\nbatch number prefix means the prefix which precedes the batch number and has the following characteristics:\n\n(a) clearly indicates that the information following the prefix is the batch number; and\n\n(b) is in the following form: ‘BATCH NUMBER’, ‘BATCH NO.’, ‘BATCH’, ‘B’, ‘(B)’, ‘B/N’, ‘LOT NUMBER’, ‘LOT NO.’, or ‘LOT’, or words or symbols to this effect, including a mixture of lower and upper case letters.\n\ncannabis plant means any plant, or part of a plant, of the genus Cannabis, including, but not limited to, the flowers, fruiting tops, seeds, stems and leaves of the plant.\n\nNote: Subspecies of the cannabis plant, Cannabis sativa, include Cannabis sativa subsp. sativa, Cannabis sativa subsp ruderalis and Cannabis sativa subsp. indica.\n\nEU Member State means a member state of the European Union.\n\nEU Directive 2001/83/EC means Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as in force or existing from time to time.\n\nEU Directive 2003/94/EC means Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use, as in force or existing at 28 March 2022.\n\nexcipient, for a medicinal cannabis product, means an ingredient that is not an active ingredient.\n\nexpiry date has the same meaning as in the Regulations.\n\nexpiry date prefix means a prefix which precedes the expiry date and has the following characteristics:\n\n(a) clearly indicates that the information following the prefix is the expiry date;\n\n(b) is in the following form: 'EXPIRY DATE', 'EXPIRY', 'EXPIRES', 'EXP. DATE', 'EXP', ‘Use by’ or ‘Use before’ or words to this effect, including a mixture of lower and upper case letters;\n\n(c) is not in the following form: 'Best by' or ‘Best before’ or words to this effect.\n\nlicensing authority means a body empowered to issue a certificate or other document to the effect that the body is satisfied that a manufacturing site complies with requirements for good manufacturing practice of therapeutic goods.\n\nmedicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of the cannabis plant.\n\nMedsafe means the New Zealand Medicines and Medical Devices Safety Authority within the New Zealand Ministry of Health.\n\nNew Zealand Code of GMP means the document New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods, published by Medsafe, as in force or existing from time to time.\n\nPIC/S means the Pharmaceutical Inspection Co-operation Scheme established in 1995 as an extension to the Pharmaceutical Inspection Convention.\n\nPIC/S Guide to GMP means the document Guide to Good Manufacturing Practice for Medicinal Products (PE 009-15, 1 May 2021) published by PIC/S, as in force or existing from time to time, and includes the Annexes to that document other than the following:\n\n(a) Annex 4 (Manufacture of veterinary medicinal products other than immunologicals);\n\n(b) Annex 5 (Manufacture of immunological veterinary medical products);\n\n(c) Annex 14 (Manufacture of medicinal products derived from human blood or plasma).\n\nplant material means dried or fresh material of the cannabis plant that has not undergone any refinement, including dried flos.\n\nNote: Refinement does not include cutting or grinding material of the cannabis plant.\n\nplant preparation means material of the cannabis plant that has undergone some refinement, excluding material of the cannabis plant that has been refined to a single cannabinoid.\n\nNote: Refinement does not include cutting or grinding material of the cannabis plant.\n\nprocessing aid means a substance used in the manufacture of a medicinal cannabis product that is not intended to remain in the final formulation of the product (although trace amounts may remain in the product).\n\nquantity of the medicinal cannabis product means:\n\n(a) where the medicinal cannabis product consists of discrete dosage units, such as tablets or capsules or sachets—the stated number of units in the container;\n\n(b) where the medicinal cannabis product is:\n\n(i) a solid or semi-solid—the stated weight in the container;\n\n(ii) a liquid—the stated volume of fill in the container;\n\n(iii) a pressurised metered-dose preparation or dry powder inhaler—the stated number of deliverable doses in the container;\n\n(iv) a non-pressurised metered dose preparation—the minimum number of deliverable doses in the container;\n\n(c) where the medicinal cannabis product is a product of any of the kinds referred to in paragraph (b) and the product consists of a number of identical containers within the primary pack—the number of containers (for example, 5 x 10 mL vials);\n\n(d) for each of the individual containers within the primary pack, the quantity of the medicinal cannabis product to be included on the individual container label would be as described in paragraph (b) (for example, the stated volume of fill in the container).\n\nRegulations means the Therapeutic Goods Regulations 1990.\n\nSouth African Guide to GMP means the document 4.01 - South African Guide to GMP (July 2019, V7), published by the South African Health Products Regulatory Authority, as in force or existing from time to time.\n\nstated content, in relation to each active ingredient in a medicinal cannabis product, means the quantity or proportion of each active ingredient that is:\n\n(a) specified on the label to be present in the medicinal cannabis product in accordance with any decision made by the Secretary under section 25 of the Act in relation to that product; or\n\n(b) disclosed to the Secretary in an application under section 19 of the Act for an approval or authority in relation to the medicinal cannabis product; or\n\n(c) disclosed to the Secretary in a notification under regulation 12A of the Regulations; or\n\n(d) purported to be present in a medicinal cannabis product that is extemporaneously compounded or repackaged by a pharmacist for a particular patient; or\n\n(e) notified to be present in a medicinal cannabis product for the purposes of item 3 of Schedule 5A to the Regulations.\n\nTGO 95 means the Therapeutic Goods Order No. 95 \\- Child-resistant packaging requirements for medicines 2017 (TGO 95).\n\nTherapeutic Goods Administration has the same meaning as in the Regulations.\n\n(2) Without limiting the meaning of active ingredient in subsection (1), the following substances are taken to be active ingredients for the purposes of this order (whether or not those ingredients are specified, disclosed, purported or notified to the Secretary to be active ingredients):\n\n(a) any tetrahydrocannabinol present in a medicinal cannabis product, the quantity or proportion of which (together with any corresponding acid) is greater than or equal to 1.0% w/w or w/v of the product; and\n\n(b) any other cannabinoid present in a medicinal cannabis product, the quantity or proportion of which (together with any corresponding acid) is greater than or equal to 2.0% w/w or w/v of the product.","sortOrder":2},{"sectionNumber":"5","sectionType":"section","heading":"Standard","content":"#### 5 Standard\n\nThis order constitutes a standard for medicinal cannabis products.","sortOrder":3},{"sectionNumber":"6","sectionType":"section","heading":"Application","content":"#### 6 Application\n\n(1) Subject to subsection (2), this order applies to:\n\n(a) medicinal cannabis products; and\n\n(b) any ingredients used in the manufacture of those products, including, but not limited to, the cannabis plant.\n\n(2) This order does not apply to medicinal cannabis products that are:\n\n(a) export only medicines; or\n\n(b) mentioned in item 1 of Schedule 5 to the Regulations; or\n\n(c) mentioned in items 4, 8, 10, 11 or 12 of Schedule 5A to the Regulations, subject to compliance with the conditions specified in those items.","sortOrder":4},{"sectionNumber":"7","sectionType":"section","heading":"Monograph","content":"#### 7 Monograph\n\nThe standard constituted by the statements in the monograph titled Pharmaceutical Preparations (2619) in the European Pharmacopoeia applies with respect to:\n\n(a) medicinal cannabis products; and\n\n(b) any ingredients used in the manufacture of those products, including, but not limited to, the cannabis plant;\n\nbut does not apply to the extent of any inconsistency with this order.\n\nNote: The Pharmaceutical Preparations (2619) monograph incorporates applicable requirements contained in other monographs that also need to be complied with, for example Herbal Drugs (1433).","sortOrder":5},{"sectionNumber":"8","sectionType":"section","heading":"Active ingredients and cannabinoids","content":"#### 8 Active ingredients and cannabinoids\n\nEach active ingredient and any other cannabinoid (that is not an active ingredient) in a medicinal cannabis product must comply with the following:\n\n(a) the active ingredient or other cannabinoid must be from the cannabis plant; and\n\n(b) the chemical structure of the active ingredient or other cannabinoid must not be modified or transformed in any way (including by chemical or other means).\n\nNote: Modification or transformation does not include decarboxylation of naturally occurring acid forms of cannabinoids.","sortOrder":6},{"sectionNumber":"9","sectionType":"section","heading":"Decontamination","content":"#### 9 Decontamination\n\nAny decontaminating treatment of the cannabis plant used in the manufacture of medicinal cannabis products must not:\n\n(a) adversely affect the quality of medicinal cannabis products; or\n\n(b) make use of, or otherwise contain, ethylene oxide.","sortOrder":7},{"sectionNumber":"10","sectionType":"section","heading":"Identification","content":"#### 10 Identification\n\nThe cannabis plants used in the manufacture of medicinal cannabis products must be positively identified using each of the following identification methods:\n\n(a) macroscopic examination; and\n\n(b) microscopic examination; and\n\n(c) chromatographic procedures.","sortOrder":8},{"sectionNumber":"11","sectionType":"section","heading":"Adulteration","content":"#### 11 Adulteration\n\n(1) Medicinal cannabis products and any ingredients used in the manufacture of those products, including, but not limited to, the cannabis plant, must not contain any substance that results in the adulteration of those products or ingredients.\n\n(2) For the purposes of subsection (1), adulteration includes the addition of, or substitution with, any substance that is extraneous to the formulation of the product, other than a processing aid.\n\n(3) In determining whether adulteration has occurred, it is irrelevant whether or not the addition or substitution is intended to improve, fortify or debase the medicinal cannabis product or any ingredients used in the manufacture of that product, including, but not limited to, the cannabis plant.","sortOrder":9},{"sectionNumber":"12","sectionType":"section","heading":"Tests","content":"#### 12 Tests\n\n(1) The tests mentioned in Schedule 1 are specified with respect to the cannabis plants used in the manufacture of medicinal cannabis products for the purposes of this order.\n\n(2) The following assay limits are specified for the purposes of this order:\n\n(a) in relation to a medicinal cannabis product in herbal final form – the average content of each active ingredient, together with any corresponding acid, in a representative sample of the product must be not less than 80.0 per cent and not more than 120.0 per cent of the stated content of that active ingredient; and\n\n(b) in relation to a medicinal cannabis product in tablet or capsule form, where that product is not included on the Register – the average content of each active ingredient, together with any corresponding acid, in a pooled sample of not fewer than 20 tablets or capsules must be not less than 90.0 per cent and not more than 110.0 per cent of the stated content of that active ingredient; and\n\n(c) in relation to a medicinal cannabis product in any other dosage form – the average content of each active ingredient, together with any corresponding acid, in a representative sample of the product must be not less than 90.0 per cent and not more than 110.0 per cent of the stated content of that active ingredient.\n\nNote: The assay limits specified in the Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019 apply with respect to registered medicinal cannabis products in tablet or capsule form.","sortOrder":10},{"sectionNumber":"13","sectionType":"section","heading":"Manufacturing quality","content":"#### 13 Manufacturing quality\n\n(1) This section does not apply to the manufacture of a medicinal cannabis product that is:\n\n(a) plant material; or\n\n(b) oil extracted directly from the cannabis plant;\n\nfor use as starting material in the manufacture of another medicinal cannabis product manufactured in accordance with:\n\n(c) subsections (2) and (3); or\n\n(d) a licence under Part 3-3 of the Act.\n\n(2) Each step of manufacture in relation to a medicinal cannabis product that occurs outside Australia must be in accordance with one or more of the following:\n\n(a) the PIC/S Guide to GMP;\n\n(b) Article 47 of EU Directive 2003/94/EC;\n\n(c) Article 47 of EU Directive 2001/83/EC;\n\n(d) the South African Guide to GMP;\n\n(e) Part 211—Current Good Manufacturing Practice for Finished Pharmaceuticals of Subchapter C—Drugs: General, in Chapter I—Food and Drugs Administration of Title 21—Food and Drugs, in the United States Code of Federal Regulations, as in force or existing from time to time;\n\n(f) Division 2 – Good Manufacturing Practices in Part C of the Food and Drug Regulations (Canada), as in force or existing from time to time;\n\n(g) the New Zealand Code of GMP.\n\n(3) A medicinal cannabis product that is manufactured outside Australia must be manufactured at a site that is the subject of one or more of the following:\n\n(a) for a medicinal cannabis product manufactured in the United Kingdom—a valid certificate of good manufacturing practice issued to the manufacturer of the product by the Medicines and Healthcare products Regulatory Agency of the United Kingdom or a licensing authority of an EU Member State;\n\n(b) for a medicinal cannabis product manufactured in an EU Member State—a valid certificate of good manufacturing practice issued to the manufacturer of the product by a licensing authority of an EU Member State;\n\n(c) for a medicinal cannabis product manufactured in Canada—either:\n\n(i) written confirmation from Health Canada that the manufacturing site operates in accordance with Part 5: Good Production Practices of the Cannabis Regulations SOR/2018-144 (Canada), as in force or existing from time to time, and:\n\n(A) a valid certificate of good manufacturing practice issued to the manufacturer of the product by a licensing authority of an EU Member State; or\n\n(B) written confirmation from the Therapeutic Goods Administration that the manufacturing site operates in accordance with the PIC/S Guide to GMP; or\n\n(ii) a Drug Establishment Licence issued by Health Canada for the relevant medicinal cannabis product manufactured at the site;\n\n(d) for a medicinal cannabis product manufactured in South Africa—written confirmation from the South African Health Products Regulatory Authority that the manufacturing site operates in accordance with the South African Guide to GMP;\n\n(e) for a medicinal cannabis product manufactured in Israel—a valid certificate of good manufacturing practice issued to the manufacturer of the product by the Israel Ministry of Health;\n\n(ea) for a medicinal cannabis product manufactured in New Zealand—one of the following:\n\n(i) a valid Licence to Manufacture Medicines issued under the Medicines Act 1981 (NZ), as in force or existing from time to time;\n\n(ii) a valid certificate of good manufacturing practice issued to the manufacturer of the product by Medsafe;\n\n(iii) written confirmation from the Therapeutic Goods Administration that the manufacturing site operates in accordance with the PIC/S Guide to GMP;\n\n(f) for a medicinal cannabis product manufactured in any other country—written confirmation from the Therapeutic Goods Administration that the manufacturing site operates in accordance with the PIC/S Guide to GMP.\n\n(4) A certificate, licence or written confirmation mentioned in subsection (3) must:\n\n(a) cover the relevant medicinal cannabis product; and\n\n(b) relate to each manufacturing site where the medicinal cannabis product was manufactured; and\n\n(c) have been current at the time the medicinal cannabis product was manufactured.","sortOrder":11},{"sectionNumber":"14","sectionType":"section","heading":"Child-resistant packaging","content":"#### 14 Child-resistant packaging\n\n(1) This section does not apply to a medicinal cannabis product that is:\n\n(a) plant material; or\n\n(b) mentioned in section 7 of TGO 95.\n\n(2) A medicinal cannabis product must comply with the requirements specified in the following sections of TGO 95:\n\n(a) section 8 (general requirements); and\n\n(b) where the product is in a reclosable package—section 9 (reclosable packages); and\n\n(c) where the product is in a non-reclosable package—section 10 (non-reclosable packages.","sortOrder":12},{"sectionNumber":"15","sectionType":"section","heading":"Labels","content":"#### 15 Labels\n\n(1) A medicinal cannabis product that is a finished product must be labelled in accordance with this section.\n\n(2) The label of a medicinal cannabis product, other than a medicinal cannabis product that is extemporaneously compounded or repackaged by a pharmacist for a particular patient, must contain all the following information:\n\n(a) the name of the medicinal cannabis product;\n\n(b) the name and contact details of the sponsor of the medicinal cannabis product;\n\n(c) the storage conditions applicable to the medicinal cannabis product;\n\n(d) the batch number of the medicinal cannabis product preceded by the batch number prefix;\n\n(e) the expiry date of the medicinal cannabis product preceded by the expiry date prefix;\n\n(f) the name of each active ingredient of the medicinal cannabis product, and the quantity of each active ingredient (including appropriate units);\n\n(g) for each active ingredient of a medicinal cannabis product that is a plant preparation—all of the following:\n\n(i) the weight of the plant preparation, and the minimum dry weight of fresh weight of the plant material from which it was prepared (including the word minimum), except where the plant preparation is an oil;\n\n(ii) the plant species;\n\n(iii) the plant part;\n\n(iv) the preparation type;\n\nExample: “Cannabis sativa leaf dry extract 5 mg, derived from Cannabis sativa leaf dry 500 mg minimum, containing THC 30 mg”.\n\n(h) for each active ingredient of a medicinal cannabis product that is plant material—all of the following:\n\n(i) the minimum dry weight or minimum fresh weight of plant material (including the word ‘minimum’);\n\n(ii) the plant species;\n\n(iii) the plant part;\n\nExample: “Cannabis sativa flower dry 500 mg minimum, containing THC 30 mg”.\n\n(i) the dosage form of the medicinal cannabis product;\n\n(j) the quantity of the medicinal cannabis product.\n\n(3) The label of a medicinal cannabis product that is extemporaneously compounded or repackaged by a pharmacist for a particular patient must state the name and quantity of each active ingredient that is purported to be present in the medicinal cannabis product.\n\n(4) All of the information that is displayed on the label of a medicinal cannabis product must be:\n\n(a) in English; and\n\n(b) legible; and\n\n(c) visible and not obscured; and\n\n(d) durable.","sortOrder":13},{"sectionNumber":"16","sectionType":"section","heading":"Microbiological attributes","content":"#### 16 Microbiological attributes\n\nA medicinal cannabis product that is in oral dosage form or for administration by inhalation must comply with the relevant acceptance criteria for microbiological quality of one of the following:\n\n(a) the British Pharmacopoeia, Appendix XVI. D Microbiological Quality of Non-Sterile Pharmaceutical Preparations and Substances for Pharmaceutical use, when tested by the methods of:\n\n(i) the British Pharmacopoeia, Appendix XVI B. Microbiological Examination of Non-Sterile Products: 2. Microbial Enumeration Tests; and\n\n(ii) the British Pharmacopoeia, Appendix XVI B. Microbiological Examination of Non-Sterile Products: 1. Test for Specified Micro-organisms; or\n\n(b) the European Pharmacopoeia, Microbiological Quality of Non-Sterile Pharmaceutical Preparations and Substances for Pharmaceutical use (5.1.4), when tested by the methods of:\n\n(i) the European Pharmacopoeia, Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests (2.6.12); and\n\n(ii) the European Pharmacopoeia, Microbiological Examination of Non-Sterile Products: Test for Specified Micro-organisms (2.6.13); or\n\n(c) the United States Pharmacopeia–National Formulary, chapter <1111>, MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: ACCEPTANCE CRITERIA FOR PHARMACEUTICAL PREPARATIONS AND SUBSTANCES FOR PHARMACEUTICAL USE, when tested by the methods of:\n\n(i) the United States Pharmacopeia–National Formulary, chapter <61> MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: MICROBIAL ENUMERATION TESTS; and\n\n(ii) the United States Pharmacopeia–National Formulary, chapter <62> MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: TESTS FOR SPECIFIED MICROORGANISMS; or\n\n(d) the Special European Pharmacopoeia (Ph. Eur.) provision for oral dosage forms containing raw materials of natural (animal, vegetal or mineral) origin for which antimicrobial pre-treatment is not feasible and for which the competent authority accepts TAMC of the raw material exceeding 1000 CFU per g or CFU per mL.","sortOrder":14},{"sectionNumber":"17","sectionType":"section","heading":"Application, savings and transitional provisions","content":"#### 17 Application, savings and transitional provisions\n\nSections 13, 14, 15 and 16 apply to medicinal cannabis products released for supply in Australia on or after 1 July 2023.\n\nSchedule 1 Specified tests\n\n(subsection 12(1))\n\n1 Interpretation\n\n(1) For each item specified in column 1 of this table, the parameter specified in column 2 must comply with the limits specified in column 4 under the test method from the European Pharmacopoeia specified in column 3.\n\n(2) With the exception of item 2 of this table, each limit specified in column 4 applies on a dried basis.\n\n2 Table of specified tests\n\n```html\n

Specified tests

Column 1

Item

Column 2

Parameter

Column 3

Test method

Column 4

Limits

1

Aflatoxins

Ph Eur 2.8.18

Not more than 2 µg/kg of aflatoxin B1 and not more than 4 µg/kg for the sum of aflatoxins B1, B2, G1, G2

2

Foreign matter

Ph Eur 2.8.2

Not more than 2.0%

3

Heavy metals

Ph Eur 2.4.27

Not more than 3.0 mg/kg of arsenic

Not more than 0.5 mg/kg of cadmium

Not more than 5.0 mg/kg of lead

Not more than 0.5 mg/kg of mercury

4

Ochratoxin A

Ph Eur 2.8.22

Not more than 20 µg/kg

5

Pesticides

Ph Eur 2.8.13

Not more than the limits specified in Ph Eur 2.8.13

6

Total ash

Ph Eur 2.4.16

Not more than 20.0%

\n```\n\nNote: In accordance with the European Pharmacopoeia, the unit mg/kg is the m/m measurement equivalent to ppm.","sortOrder":15}],"analysis":{"flash_summary":{"complexity_score":7,"scope_assessment":{"changed":false,"description":"This instrument functions as a technical product standard for medicinal cannabis products and their ingredients. It confines itself to setting quality, testing, labelling, packaging and manufacturing requirements and names acceptable external standards and jurisdictions for GMP recognition (s5–16). The 2017 Order and its provisions consolidate and specify technical requirements rather than substantially expanding the policy scope beyond establishing product quality and safety criteria; therefore it has not grown significantly beyond that original purpose. The transitional timing provision (s17) phases in compliance but does not change the substantive scope."},"complexity_factors":["Extensive interpretation section with ~30 defined or cross‑referenced expressions (s4).","Multiple external references to pharmacopoeias and GMP frameworks (European Pharmacopoeia, British Pharmacopoeia, USP–NF, PIC/S, EU Directives, US CFR, Canadian regulations, NZ Code, South African Guide) (s7, s12, s13, s16, Schedule 1).","Country‑specific conditional rules for overseas manufacture with many branches and documentary requirements (s13(2)–(4)).","Detailed labelling prescriptions with multiple conditional items for plant preparations vs plant material (s15(2)(f)–(h)).","Assay limits that vary by dosage form and registration status, plus cross‑reference to another TGO for registered tablets/capsules (s12).","Prohibition and procedural rules (e.g. ethylene oxide ban; identification methods) that interact with manufacturing practice (s9, s10).","Transitional and savings provision that phases parts of the order (s17).","Schedule 1 with numerical contaminant limits and specified pharmacopoeial test methods (Schedule 1)."],"plain_english_summary":"**What this order does (mechanics first)**\n\n- Establishes a legally binding product standard for medicinal cannabis products and the raw ingredients used to make them (s5, s6). It sets required tests, manufacturing quality, labelling, packaging and microbiological limits, and identifies which external pharmacopoeial and good‑manufacturing practice (GMP) standards may be used to show compliance (s7, s12–16).\n\n- Controls what counts as an active ingredient for these products: any THC at or above 1.0% (including its acid form), and any other cannabinoid at or above 2.0% are treated as active ingredients for the purposes of the order (s4(2)).\n\n- Requires plant material to be identified by macroscopic, microscopic and chromatographic methods (s10), bans ethylene oxide for decontamination (s9), and prohibits adulteration (s11).\n\n- Specifies chemical and microbiological tests and limits for cannabis plant material and finished products (Schedule 1; s12, s16). Schedule 1 lists contaminant tests (aflatoxins, ochratoxin A, heavy metals, pesticides, foreign matter, total ash) and gives numerical limits.\n\n- Requires particular manufacturing quality arrangements for products made outside Australia. Manufacture abroad must follow one of a list of recognised GMP frameworks (e.g. PIC/S Guide, specified EU or national regulations) and the overseas site must hold an appropriate GMP certificate or TGA confirmation, depending on the country (s13(2)–(4)).\n\n- Requires child‑resistant packaging consistent with the separate child‑resistant packaging order (TGO 95) except where expressly exempted (s14).\n\n- Sets mandatory labelling content for finished medicinal cannabis products (except pharmacy extemporaneous compounds), including: product name, sponsor contact, storage conditions, batch number (with specified prefix), expiry date (with specified prefix), each active ingredient and quantity, plant species/part and preparation details where the active is a plant preparation or plant material, dosage form and quantity (s15).\n\n- Phases in the manufacturing, packaging, labelling and microbiological requirements for products released on or after 1 July 2023 (transitional savings) (s17).\n\n\n**Who this affects**\n\n- Manufacturers of medicinal cannabis products (domestic and overseas) — must meet the manufacturing quality, testing and identification requirements (s10–13).\n- Sponsors and importers — responsible for ensuring labelling and product compliance before supply in Australia (s15, s6).\n- Testing laboratories — required to perform the specified tests and apply the pharmacopoeial methods cited in the order and Schedule 1 (s12, Schedule 1).\n- Pharmacists who extemporaneously compound or repackage for an individual patient — partly exempt from finished product labelling rules but must state purported active ingredients (s15(3)).\n- Packaging suppliers — must enable child‑resistant compliance where applicable (s14).\n\n\n**Why it matters (stated purpose and trade‑offs)**\n\n- The order’s explicit purpose is to set an enforceable quality, safety and information baseline for medicinal cannabis products supplied in Australia (s5, s6). By doing so the regulator creates a common set of technical requirements for testing, manufacture, labelling and packaging (s7, s12–16).\n\n- Costs and who pays: compliance costs fall primarily on manufacturers and sponsors — they must fund sampling, analytical testing, GMP certification or confirmation, labelling changes, and child‑resistant packaging (ss 12–16). Where manufacture is outsourced overseas, the manufacturer or sponsor must ensure the foreign site has the required certificates or TGA confirmation (s13(3)–(4)).\n\n- Who decides: the Therapeutic Goods Administration (the Secretary under the Therapeutic Goods Act) controls acceptances and confirmations referenced throughout (for example, acceptance of stated content, approvals under s25 of the Act referred to in the definitions, and written confirmation of GMP equivalence in s13(3)(f)).\n\n- Behavioural effects and incentives:\n - Manufacturers will need to put in place analytical controls, traceability (batch numbers; s4 definition and s15(d)), and GMP documentation to access the Australian market (s12, s13, s15).\n - Naming specific recognized GMP standards and accepted foreign regulators (UK, EU Member States, Canada, Israel, South Africa, New Zealand, PIC/S, etc.) creates a predictable compliance pathway for manufacturers already certified to those systems and raises the barrier for producers not already certified (s13(2)–(3)).\n - The order’s thresholds for automatically classifying cannabinoids as active ingredients (THC ≥1.0% and others ≥2.0%) will determine when full active‑ingredient labelling and assay requirements apply and thus affect formulation choices and product positioning (s4(2), s12).\n\n- Trade‑offs and implementation risk:\n - Reliance on multiple external pharmacopoeias and foreign GMP certificates means effective enforcement depends on evaluating foreign documentation and on TGA procedural capacity (s7, s13). That reduces ambiguity for compliant, certified exporters but increases administrative work for TGA and for firms seeking novel compliance routes.\n - The order excludes export‑only medicines and certain schedule items from its application (s6), so not all cannabis products are captured.\n\n\n**Concrete, cited points of likely market impact**\n\n- Small, domestic cultivators and processors may face higher per‑unit compliance costs because the order requires pharmacopeial contaminant testing (Schedule 1) and adherence to GMP standards for finished products and many manufacturing steps (s12, s13). These costs are paid by manufacturers/sponsors (s12, s13, s15).\n\n- Firms already holding GMP certification from the listed jurisdictions (UK MHRA, EU regulators, Health Canada with listed confirmations, Israel MoH, South African HPRA, Medsafe NZ, PIC/S etc.) gain a compliance advantage because the order expressly recognises those certificates for overseas manufacture (s13(3)).\n\n- Labelling and traceability: sponsors must put batch numbers, expiry dates (with specified prefixes), active ingredient content, plant species/part and minimum starting material weights for plant preparations or material on labels (s15). That increases information available to prescribers and patients but requires operational changes to packaging and labelling workflows (s15(2)(d)–(h)).\n\n- Child safety: where applicable, products must meet the child‑resistant packaging requirements in TGO 95 (s14), requiring compatible primary or secondary packaging solutions (s14(2)).\n\n\n**Implementation details and limits**\n\n- Tests and limits: Schedule 1 and s12 provide numerical limits for aflatoxins, ochratoxin A, heavy metals, pesticides, foreign matter and total ash (Schedule 1). Microbiological acceptance criteria for oral and inhalation products must follow one of the listed pharmacopoeial sources (s16).\n\n- Decontamination: ethylene oxide is prohibited for decontamination of cannabis plant material (s9).\n\n- Transitional: the manufacturing, packaging, labelling and microbiological requirements apply to products released for supply in Australia on or after 1 July 2023 (s17). Earlier‑released stock is therefore not required to be retrofitted to these rules.\n\n\n**Bottom line — in plain terms**\n\nThis order sets the technical quality, testing, packaging and labelling rules that medicinal cannabis products must meet to be lawfully supplied in Australia (s5–16). The immediate consequences are higher compliance and testing burdens for manufacturers and sponsors, clearer acceptance routes for firms already certified to named foreign GMP systems, and more detailed labelling and traceability for consumers and regulators (ss 12–15, Schedule 1, s13)."},"flash_summary_failed":{"failed":true,"reason":"A positive credit balance is required for all requests, including BYOK, so fallback providers remain available. Add credits at https://vercel.com/d?to=%2F%5Bteam%5D%2F%7E%2Fai%3Fmodal%3Dtop-up to continue.","source":"analysis-cron"},"kimi_summary":{"content_quality":"ok","complexity_score":6,"scope_assessment":{"changed":false,"description":"The legislation maintains its original scope as a technical standard for medicinal cannabis quality. The 2023 amendments expanded the recognised international manufacturing standards (adding Israel, New Zealand, and South Africa options) and deferred commencement dates, but these represent operational refinements within the established framework rather than scope creep. The core purpose—establishing quality standards for medicinal cannabis—remains unchanged."},"complexity_factors":["24 defined terms in section 4, plus 12 terms incorporated by reference from the parent Act","Extensive cross-referencing to international standards: European Pharmacopoeia, British Pharmacopoeia, US Pharmacopeia, PIC/S Guide to GMP, EU Directives 2001/83/EC and 2003/94/EC, plus national GMP codes from Canada, South Africa, New Zealand, UK, and Israel","Nested conditional logic in manufacturing requirements: different rules apply based on (a) whether manufacture is in Australia or overseas, (b) which specific country overseas, and (c) what type of product (plant material vs oil vs finished product)","Multiple exemption clauses: section 13(1) exempts starting materials; section 14(1) exempts plant material from child-resistant packaging; section 6(2) exempts export-only medicines and certain scheduled items","Complex labelling requirements with alternative formats for different product types (plant material vs plant preparation vs extemporaneously compounded products)","Variable assay limits (80-120% vs 90-110%) depending on product form and registration status","Transitional provision deferring application of sections 13-16 until 1 July 2023","Incorporation of external documents 'as in force or existing from time to time' creating dynamic referencing"],"plain_english_summary":"This law sets national quality and safety rules for medicinal cannabis products in Australia, covering products made from any part of the cannabis plant. It requires GMP manufacturing, contaminant and microbiological testing, plant-derived cannabinoids at 80–120% of labelled strength, specific labelling, and child‑resistant packaging, and bans harmful decontamination methods.\n\nIt affects companies that make, import or supply medicinal cannabis, pharmacists who prepare bespoke products, and patients, ensuring medicines meet prescription‑grade safety and quality standards."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-standard-for-medicinal-cannabis-tgo-93-order-2017","history":"/api/acts/therapeutic-goods-standard-for-medicinal-cannabis-tgo-93-order-2017/history","analysis":"/api/acts/therapeutic-goods-standard-for-medicinal-cannabis-tgo-93-order-2017/analysis","conflicts":"/api/acts/therapeutic-goods-standard-for-medicinal-cannabis-tgo-93-order-2017/conflicts","importantCases":"/api/acts/therapeutic-goods-standard-for-medicinal-cannabis-tgo-93-order-2017/important-cases","documents":"/api/acts/therapeutic-goods-standard-for-medicinal-cannabis-tgo-93-order-2017/documents"}}