{"id":"F2021L01087","name":"Therapeutic Goods (Medicinal Cannabis Products) (Information) Specification 2021","slug":"therapeutic-goods-medicinal-cannabis-products-information-specification-2021","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":440952,"registerId":"F2021L01087-fast-fetch-1775956394106","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods (Medicinal Cannabis Products) (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![Commonwealth Coat of Arms of Australia](image.001.jpeg)\n\n \n\nTherapeutic Goods (Medicinal Cannabis Products) (Information) Specification 2021\n\nI, John Skerritt, as delegate of the Minister for Health and Aged Care, make the following specification.\n\nDated 4 August 2021\n\nAdjunct Professor John Skerritt\n\nDeputy Secretary\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) (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The day after this instrument is registered.\n\n\nNote: This table relates only to the provisions of this instrument as originally made.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) current Poisons Standard;\n\n(b) health practitioner;\n\n(c) indications;\n\n(d) 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 application means an application for 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\nauthorised prescriber report means a report provided to the Secretary in accordance with regulation 47B of the Regulations by a person authorised under subsection 19(5) of the Act.\n\nmedical practitioner has the same meaning as in subsection 19(9) of the Act.\n\nmedicinal cannabis products has the same meaning as in the Regulations.\n\nRegulations means the Therapeutic Goods Regulations 1990.\n\nrelevant product means a medicinal cannabis product that is the subject of one of the following:\n\n (a) an authorised prescriber application;\n\n (b) an authorised prescriber report;\n\n (c) a SAS A notification;\n\n (d) a SAS B application.\n\nSAS A notification means a statement referred to in subparagraph 12A(2)(a)(iii) of the Regulations that is sent to the Secretary in accordance with subregulation 12A(3) of the Regulations.\n\nNote: Regulation 12A is made for the purposes of subsection 18(1) of the Act, and exempts certain medicines for use in life-threatening cases from the operation of Part 3-2A of the Act.\n\nSAS B application means an application made in accordance with subsection 19(2) of the Act for 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 | the number of submissions, being authorised prescriber applications, SAS A notifications and SAS B applications made in relation to relevant products, by reference to one or more of the following:<br>     a time period;    the relevant pathway for the applications or notifications;     the status of the applications or notifications, such as approved, withdrawn, refused, pending and received;    the number of medical practitioners or health practitioners who made the applications or notifications;     the states or territories in which the practitioners mentioned in paragraph (d) are located;     the speciality (if any) of the practitioners mentioned in paragraph (d);    the numbers of patients to whom authorised prescriber reports, SAS A notifications or SAS B applications relate by age range;    the number of patients to whom authorised prescriber reports, SAS A notifications or SAS B applications relate by gender;      the indications specified in the applications or notifications in relation to the relevant products;      the dosage forms of the relevant products;    the name and strength of the active ingredients of the relevant products;      the schedule to the current Poisons Standard (otherwise known as the SUSMP Schedule) in which a substance contained in the relevant products is included;  the number of patients for whom repeat approvals in relation to a SAS B application have been granted |\n\n\n \n","sortOrder":0}],"analysis":{"flash_summary":{"complexity_score":3,"scope_assessment":{"changed":false,"description":"The instrument specifies types of therapeutic goods information that the Secretary may disclose publicly (s.5; Schedule 1). It does not amend reporting obligations, approval criteria, fees, or the regulatory pathways themselves; it therefore does not change the substantive scope of regulation under the Act but defines what information may be released."},"complexity_factors":["Narrow, specific scope limited to authorising release of specified information rather than changing substantive regulation (s.5; Schedule 1).","Relies on definitions and interaction with the Therapeutic Goods Act 1989 and Therapeutic Goods Regulations 1990 (ss.3–4).","References multiple regulatory pathways (authorised prescriber, SAS A notifications, SAS B applications) requiring cross‑dataset aggregation (definitions; Schedule 1).","Granular and varied data categories (counts by time, status, practitioner specialty, state/territory, patient age/gender, indications, dosage form, active ingredient/strength, scheduling) increase implementation detail and potential privacy considerations (Schedule 1).","Administrative discretion: instrument enables release under subsection 61(5C) of the Act but does not prescribe publication processes or formats, leaving operational detail to the Secretary (s.5).","Commencement and authority provisions are straightforward but require coordination with existing reporting/approval flows (ss.2–3)."],"plain_english_summary":"This specification authorises the Secretary to publish categories of information about medicinal cannabis products and related regulatory submissions — counts and breakdowns of authorised prescriber, SAS A and SAS B submissions; practitioner location and specialty; patient numbers by age and gender; indications, dosage forms, active ingredients/strengths; scheduling; and repeat approvals (s.5; Schedule 1). It affects practitioners, patients and sponsors; it enables public disclosure under the Therapeutic Goods Act and does not create fees or change approval pathways (ss.3–5)."},"kimi_summary":{"content_quality":"ok","complexity_score":3,"scope_assessment":{"changed":false,"description":"The instrument remains tightly focused on its original purpose: specifying what therapeutic goods information about medicinal cannabis products may be released to the public. It does not expand beyond the information disclosure framework established in section 61 of the Therapeutic Goods Act 1989."},"complexity_factors":["Short instrument: only 5 substantive sections plus a schedule","Minimal defined terms: 9 definitions in section 4, mostly referencing external legislation","Simple structure: linear flow from definitions to operative provision (section 5) to detailed table","Heavy reliance on external references: definitions point to Therapeutic Goods Act 1989 and Therapeutic Goods Regulations 1990 rather than defining terms internally","Single operative mechanism: one table in Schedule 1 listing 13 categories of publishable information","No conditional logic or exceptions: straightforward specification without nested provisions"],"plain_english_summary":"This law authorises the Secretary of Health to publish aggregated, de‑identified statistics about medicinal cannabis access in Australia — covering application numbers and outcomes, prescriber counts and locations, patient demographics and indications, product ingredients/strength/form and repeat prescriptions.  \n\nIt affects patients (while protecting individual privacy), doctors, researchers and policymakers by increasing transparency to monitor prescribing trends, safety and inform policy."},"flash_summary_failed":{"failed":true,"reason":"Unauthenticated. Configure AI_GATEWAY_API_KEY or use a provider module. Learn more: https://ai-sdk.dev/unauthenticated-ai-gateway","source":"analysis-cron"}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-medicinal-cannabis-products-information-specification-2021","history":"/api/acts/therapeutic-goods-medicinal-cannabis-products-information-specification-2021/history","analysis":"/api/acts/therapeutic-goods-medicinal-cannabis-products-information-specification-2021/analysis","conflicts":"/api/acts/therapeutic-goods-medicinal-cannabis-products-information-specification-2021/conflicts","importantCases":"/api/acts/therapeutic-goods-medicinal-cannabis-products-information-specification-2021/important-cases","documents":"/api/acts/therapeutic-goods-medicinal-cannabis-products-information-specification-2021/documents"}}