{"id":"F2021L01582","name":"Therapeutic Goods (Medicinal Cannabis Products—Approvals and Authorities) (Information) Specification 2021","slug":"therapeutic-goods-medicinal-cannabis-products-approvals-and-authorities-information-specification-20","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":441066,"registerId":"F2021L01582-fast-fetch-1775956483088","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods (Medicinal Cannabis Products—Approvals and Authorities) (Information) Specification 2021","content":"---\nmeta-content-style-type: text/css\nmeta-content-type: application/xhtml+xml; charset=utf-8\n---\n\n?xml version=\"1.0\" encoding=\"utf-8\" standalone=\"no\"?>\n\n\n\n \n\nTherapeutic Goods (Medicinal Cannabis Products—Approvals and Authorities) (Information) Specification 2021\n\nI, Jane Cook, as delegate of the Minister for Health and Aged Care, make the following specification.\n\nDated 19 November 2021\n\nDr Jane Cook\n\nFirst Assistant Secretary\n\nMedicines Regulation Division\n\nHealth Products Regulation Group\n\nDepartment of Health\n\n \n\n \n\n \n\nContents\n\n1 Name\n\n2 Commencement\n\n3 Authority\n\n4 Definitions\n\n5 Release of therapeutic goods information\n\nSchedule 1—Specified kinds of therapeutic goods information\n\n \n\n \n\n1 Name\n\n This instrument is the Therapeutic Goods (Medicinal Cannabis Products—Approvals and Authorities) (Information) Specification 2021.\n\n2 Commencement\n\n (1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.\n\n \n\n- Commencement information\n- Column 1 Column 2 Column 3\n- Provisions Commencement Date/Details\n- 1. The whole of this instrument The day after this instrument is registered.\n\n\nNote: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.\n\n (2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.\n\n3 Authority\n\n This instrument is made under subsection 61(5D) of the Therapeutic Goods Act 1989.\n\n4 Definitions\n\nNote: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:\n\n(a) Secretary.\n\n In this instrument:\n\nAct means the Therapeutic Goods Act 1989.\n\nactive ingredient has the same meaning as in the Regulations.\n\nauthorised prescriber authority means an authority under subsection 19(5) of the Act.\n\nNote: Subsection 19(5) of the Act provides that the Secretary may authorise a medical practitioner to supply specified therapeutic goods for use in the treatment of humans, or a specified class of such goods, to a class or classes of recipients specified in the authority.\n\ncategory 1 means the category of medicinal cannabis product that is a cannabidiol medicinal cannabis product where:\n\n (a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and\n\n (b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and\n\n (c) the medicine contains no other active ingredients.\n\ncategory 2 means the category of medicinal cannabis product that is a cannabidiol-dominant medicinal cannabis product where:\n\n (a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and\n\n (b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and\n\n (c) the medicine contains no other active ingredients.\n\ncategory 3 means the category of medicinal cannabis product that is a balanced medicinal cannabis product where:\n\n (a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and\n\n (b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and\n\n (c) the medicine contains no other active ingredients.\n\ncategory 4 means the category of medicinal cannabis product that is a tetrahydrocannabinol-dominant medicinal cannabis product where:\n\n (a) cannabinoids other than cannabidiol (including tetrahydrocannabinol) derived from cannabis comprise 60% or more and 98% or less of the total cannabinoid content of the medicine; and\n\n (b) cannabidiol derived from cannabis comprises 2% or more and 40% or less of the total cannabinoid content of the medicine; and\n\n (c) the medicine contains no other active ingredient.\n\ncategory 5 means the category of medicinal cannabis product that is a tetrahydrocannabinol medicinal cannabis product where:\n\n (a) cannabinoids other than cannabidiol (including tetrahydrocannabinol) comprise more than 98% of the total cannabinoid content of the medicine; and\n\n (b) cannabidiol comprises less than 2% of the total cannabinoid content of the medicine; and\n\n (c) the medicine contains no other active ingredient.\n\nmedicinal cannabis products has the same meaning as in the Regulations.\n\nRegulations means the Therapeutic Goods Regulations 1990.\n\nrelevant category, in relation to a medicinal cannabis product, means one of the following categories, as applicable:\n\n (a) category 1;\n\n (b) category 2;\n\n (c) category 3;\n\n (d) category 4;\n\n (e) category 5.\n\nSAS B approval means an approval under paragraph 19(1)(a) of the Act.\n\nNote: Paragraph 19(1)(a) of the Act provides that the Secretary may grant an approval for the importation into, or the exportation from, Australia or the supply in Australia of specified therapeutic goods that are not registered goods, listed goods or exempt goods for use in the treatment of another person.\n\ntherapeutic goods information has the meaning given by subsection 61(1) of the Act.\n\n5 Release of therapeutic goods information\n\n The kinds of therapeutic goods information set out in the table in Schedule 1 are specified for the purpose of subsection 61(5C) of the Act.\n\nNote: Kinds of therapeutic goods information specified under subsection 61(5D) of the Act may be released by the Secretary to the public under subsection 61(5C).\n\n\n\n\nSchedule 1—Specified kinds of therapeutic goods information\n\nNote: See section 5.\n\n \n\n| Column 1 | Column 2 |\n| --- | --- |\n| Item | Kinds of information |\n| 1 | information relating to a medicinal cannabis product that is the subject of an authorised prescriber authority or a SAS B approval, including the following:
(a) active ingredient;
(b) dosage form;
(c) product name;
(d) relevant category;
(e) sponsor name;
|\n\n\n \n","sortOrder":0}],"analysis":{"kimi_summary":{"content_quality":"ok","complexity_score":3,"scope_assessment":{"changed":false,"description":"This instrument remains tightly focused on its original purpose: specifying what therapeutic goods information about medicinal cannabis products can be released to the public. It implements a specific provision (subsection 61(5D)) of the Therapeutic Goods Act 1989 without expanding beyond that mandate."},"complexity_factors":["Short instrument with only 5 substantive sections plus a schedule","11 defined terms in section 4, but most are straightforward chemical composition percentages","Simple tabular structure in Schedule 1 with only one item","No nested exceptions or complex conditional logic","Clear cross-references to the parent Act (Therapeutic Goods Act 1989) but doesn't create complex interdependencies","Mathematical categorisation system (percentages) is precise but not legally complex"],"plain_english_summary":"This law requires the government to publicly list key details about medicinal cannabis products approved for prescribing through authorised prescriber authorities and SAS B approvals. It affects patients, prescribers, sponsors, researchers and the public by creating transparency on legally available cannabis medicines. Listings will show product name, form, active ingredients, sponsor and a CBD/THC-based category (five categories from almost-pure CBD to almost-pure THC)."},"flash_summary":{"complexity_score":3,"scope_assessment":{"changed":false,"description":"This instrument does not change which products require approvals or the legal approval pathways; it specifies the kinds of therapeutic goods information the Secretary may release under the Act (see section 5 and Schedule 1) and defines product categories (section 4). It does not amend the Therapeutic Goods Act 1989 or the Regulations, so substantive regulatory scope remains the same; the instrument alters only what information may be published and how products are categorised for that purpose."},"complexity_factors":["Detailed technical thresholds for five cannabinoid-based product categories (definitions of category 1–5 in section 4) increase precision requirements for classification.","Multiple statutory cross-references and delegations: relies on the Therapeutic Goods Act 1989 definitions and powers (authority under subsection 61(5D); release under subsection 61(5C)) (sections 3 and 5).","Interaction with approvals regimes: applies only to products subject to authorised prescriber authorities or SAS B approvals (definitions and Schedule 1), requiring coordinate compliance by sponsors and prescribers.","Specification formality: instrument is a delegated legislative instrument made by a Ministerial delegate (header and section 3), so administrative procedure and publication rules matter for enforceability.","Commencement mechanics and publishing notes (section 2) create procedural detail about when the specification takes effect and how published versions may include non-legislative annotations.","Schedule presentation: the table in Schedule 1 sets out kinds of information but the schedule-based format requires care when interpreting scope and any later amendments."],"plain_english_summary":"This specification directs the Department of Health to publish certain information about medicinal cannabis products that have an authorised prescriber authority or an SAS B approval. Mechanically, it lists the types of product information the Secretary may release (examples include active ingredient, dosage form, product name, category and sponsor) and defines five cannabinoid-based product categories. The Secretary decides what to publish under subsection 61(5C) (see section 5 and Schedule 1). Sponsors face disclosure and reputational consequences; administrators exercise release discretion."},"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"}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-medicinal-cannabis-products-approvals-and-authorities-information-specification-20","history":"/api/acts/therapeutic-goods-medicinal-cannabis-products-approvals-and-authorities-information-specification-20/history","analysis":"/api/acts/therapeutic-goods-medicinal-cannabis-products-approvals-and-authorities-information-specification-20/analysis","conflicts":"/api/acts/therapeutic-goods-medicinal-cannabis-products-approvals-and-authorities-information-specification-20/conflicts","importantCases":"/api/acts/therapeutic-goods-medicinal-cannabis-products-approvals-and-authorities-information-specification-20/important-cases","documents":"/api/acts/therapeutic-goods-medicinal-cannabis-products-approvals-and-authorities-information-specification-20/documents"}}