{"id":"F2022L01673","name":"Therapeutic Goods (Biologicals—Authorised Supply) Rules 2022","slug":"therapeutic-goods-biologicals-authorised-supply-rules-2022","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":102969,"registerId":"commonwealth-F2022L01673-current","compilationNumber":null,"startDate":"2026-04-03","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Name","content":"#### 1 Name\n\nThis instrument is the Therapeutic Goods (Biologicals—Authorised Supply) Rules 2022.","sortOrder":0},{"sectionNumber":"3","sectionType":"section","heading":"Authority","content":"#### 3 Authority\n\nThis instrument is made under subsection 32CM(7A) of the Therapeutic Goods Act 1989.","sortOrder":1},{"sectionNumber":"4","sectionType":"section","heading":"Definitions","content":"#### 4 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) biological;\n\n(b) health practitioner;\n\n(c) included in the Register;\n\n(d) Register;\n\n(e) sponsor;\n\n(f) supply.\n\nIn this instrument:\n\nAct means the Therapeutic Goods Act 1989.\n\nadverse event means an adverse event that occurs in relation to a person in Australia following the administration of a biological.\n\nNote: An adverse event may not necessarily have a causal relationship with the administration or use of the biological.\n\nTherapeutic Goods Administration has the same meaning as in the Therapeutic Goods Regulations 1990.","sortOrder":2},{"sectionNumber":"5","sectionType":"section","heading":"Authorisation","content":"#### 5 Authorisation\n\nSupply by a specified health practitioner\n\n(1) A health practitioner specified in column 5 of an item in the table in Schedule 1 is authorised to supply a biological to a patient of that practitioner where:\n\n(a) the biological is specified in column 2 of that item; and\n\n(b) the biological is to be administered by the route specified in column 3 of that item; and\n\n(c) the supply is for the indication specified in column 4 of that item; and\n\n(d) the conditions specified in subsection (2) are satisfied.\n\n(2) The health practitioner must:\n\n(a) inform the patient, or a parent or guardian of the patient, that the biological is not included in the Register; and\n\n(b) obtain informed consent from the patient, or a parent or guardian of the patient, in relation to, and before, the supply of the biological; and\n\n(c) supply the biological in accordance with good medical practice or the relevant code of conduct for the health practitioner; and\n\n(d) if the health practitioner becomes aware that the patient has suffered an adverse event in relation to the biological—notify the Therapeutic Goods Administration within 15 days of becoming aware of the adverse event; and\n\n(e) if the health practitioner becomes aware of a defect in the biological—notify the Therapeutic Goods Administration within 15 days of becoming aware of the defect.\n\nSupply to a patient of a specified health practitioner\n\n(3) A health practitioner is authorised to supply a biological to a patient of a health practitioner specified in column 5 of an item in the table in Schedule 1 (the treating practitioner) where:\n\n(a) the biological is specified in column 2 of that item; and\n\n(b) the supply is requested by the treating practitioner; and\n\n(c) the biological is to be administered by the route specified in column 3 of that item; and\n\n(d) the supply is for the indication specified in column 4 of that item; and\n\n(e) the conditions specified in subsection (4) are satisfied.\n\n(4) The health practitioner supplying the biological must:\n\n(a) if the health practitioner becomes aware that the patient has suffered an adverse event in relation to the biological—notify the Therapeutic Goods Administration within 15 days of becoming aware of the adverse event; and\n\n(b) if the health practitioner becomes aware of a defect in the biological—notify the Therapeutic Goods Administration within 15 days of becoming aware of the defect.\n\n \n\nSchedule 1—Biologicals authorised for supply\n\nNote: See section 5.\n\n```html\n

Specified therapeutic goods

Column 1

Column 2

Column 3

Column 4

Column 5

Item

Biological

Route of administration

Indication

Health practitioner

3

Amniotic Membrane

ophthalmic

ocular conditions

medical practitioner

8

Ortho-ATI (tenocytes) cell suspension

intratendinous injection

treatment of chronic lateral epicondylitis or gluteal tendinopathy (> 6 months) with or without partial tendon tear, that is not responsive to conservative treatment

orthopaedic surgeon

11

Tutoplast Pericardium (sterilised human tissue allograft)

topical

soft tissue graft

medical practitioner

\n```","sortOrder":3}],"analysis":{"kimi_summary":{"content_quality":"ok","complexity_score":3,"scope_assessment":{"changed":false,"description":"The legislation appears tightly scoped to its original purpose of authorising supply of specific unregistered biologicals by specified practitioners. The Schedule contains only 3 items, suggesting a narrow, controlled approach rather than scope creep."},"complexity_factors":["Short instrument with only 5 substantive sections","Simple tabular structure in Schedule 1 with only 3 listed biologicals","Straightforward conditional logic (if X, then Y) without nested exceptions","Minimal cross-referencing (only to parent Act and Regulations for definitions)","Only 2 defined terms in the instrument itself ('Act' and 'adverse event'), with others imported by reference","Clear practitioner obligations set out in plain bullet-point format"],"plain_english_summary":"This law creates a limited, controlled pathway allowing certain medical practitioners (including orthopaedic surgeons) to supply a short list of specified biological products for designated conditions even though those products aren’t registered with the TGA. It affects patients seeking these treatments, the clinicians who supply them, and the TGA’s safety oversight. Key safeguards require informed consent, adherence to good medical practice, and mandatory reporting of adverse events or defects to the TGA within 15 days."},"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"},"flash_summary":{"complexity_score":4,"scope_assessment":{"changed":false,"description":"The instrument confines authorisation to the listed biologicals, routes and indications in Schedule 1 under the power in subsection 32CM(7A) of the Act. It sets procedural and reporting conditions but does not, on its face, broaden the classes of persons or products beyond those expressly listed."},"complexity_factors":["Cross-references to the Act for defined terms (see section 4 referencing subsection 3(1) of the Act).","Relies on a schedule (Schedule 1) to identify applicable biologicals, routes and indications rather than embedding those lists in the rule text.","Two modes of authorisation: direct supply by the treating practitioner (s5(1)–(2)) and supply to a patient at the request of a specified treating practitioner (s5(3)–(4)).","Multiple mandatory conditions on suppliers including patient information, informed consent and professional standards (s5(2)(a)–(c)).","Reporting obligations with a fixed 15‑day timeframe for adverse events and defects (s5(2)(d)–(e), s5(4)(a)–(b)), which create clear compliance deadlines.","Specificity of application by practitioner type, route and indication in the Schedule reduces generalisability but increases administrative precision."],"plain_english_summary":"This instrument authorises specified health practitioners to supply certain biological products that are not included in the Register, limited to the products, administration routes and indications listed in Schedule 1. Practitioners must inform patients, obtain informed consent, follow professional practice, and notify the Therapeutic Goods Administration of any adverse event or defect within 15 days. It affects the listed practitioners and their patients by allowing off‑Register use of particular biologicals under defined procedural and reporting safeguards."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-biologicals-authorised-supply-rules-2022","history":"/api/acts/therapeutic-goods-biologicals-authorised-supply-rules-2022/history","analysis":"/api/acts/therapeutic-goods-biologicals-authorised-supply-rules-2022/analysis","conflicts":"/api/acts/therapeutic-goods-biologicals-authorised-supply-rules-2022/conflicts","importantCases":"/api/acts/therapeutic-goods-biologicals-authorised-supply-rules-2022/important-cases","documents":"/api/acts/therapeutic-goods-biologicals-authorised-supply-rules-2022/documents"}}