Therapeutic Goods (Biologicals—Authorised Supply) Rules 2022 made under subsection 32CM(7A) of the Therapeutic Goods Act 1989 Compilation No. 3 Compilation date: 17 October 2024 Includes amendments up to: F2024L01321 About this compilation This compilation This is a compilation of the Therapeutic Goods (Biologicals—Authorised Supply) Rules 2022 that shows the text of the law as amended and in force on 17 October 2024 (the compilation date). The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law. Uncommenced amendments The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the Register for the compiled law. Application, saving and transitional provisions for provisions and amendments If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes. Modifications If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the Register for the compiled law. Self‑repealing provisions If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes. Contents 1 Name 3 Authority 4 Definitions 5 Authorisation Schedule 1—Biologicals authorised for supply Endnotes Endnote 1—About the endnotes Endnote 2—Abbreviation key Endnote 3—Legislation history Endnote 4—Amendment history 1 Name This instrument is the Therapeutic Goods (Biologicals—Authorised Supply) Rules 2022. 3 Authority This instrument is made under subsection 32CM(7A) of the Therapeutic Goods Act 1989. 4 Definitions Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following: (a) biological; (b) health practitioner; (c) included in the Register; (d) Register; (e) sponsor; (f) supply. In this instrument: Act means the Therapeutic Goods Act 1989. SAS Guidance means the document titled Special Access Scheme (SAS): Guidance for health practitioners accessing unapproved therapeutic goods (Version 3.0, October 2024) published by the Therapeutic Goods Administration, as in force or existing on 1 October 2024. Note: The SAS Guidance is published at www.tga.gov.au. Therapeutic Goods Administration has the same meaning as in the Therapeutic Goods Regulations 1990. 5 Authorisation Supply by a specified health practitioner (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: (a) the biological is specified in column 2 of that item; and (b) the biological is to be administered by the route specified in column 3 of that item; and (c) the supply is for the indication specified in column 4 of that item; and (d) the conditions specified in subsection (2) are satisfied. (2) The health practitioner must: (a) inform the patient, or a parent or guardian of the patient, that the biological is not included in the Register; and (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 (c) supply the biological in accordance with good medical practice or the relevant code of conduct for the health practitioner; and (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 and the sponsor of the biological about the adverse event in accordance with the reporting guidelines set out in the SAS Guidance; and (e) if the health practitioner becomes aware of a defect in the biological—notify the Therapeutic Goods Administration and the sponsor of the biological in accordance with the reporting guidelines set out in the SAS Guidance. Supply to a patient of a specified health practitioner (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: (a) the biological is specified in column 2 of that item; and (b) the supply is requested by the treating practitioner; and (c) the biological is to be administered by the route specified in column 3 of that item; and (d) the supply is for the indication specified in column 4 of that item; and (e) the conditions specified in subsection (4) are satisfied. (4) The health practitioner supplying the biological must: (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 and the sponsor of the biological about the adverse event in accordance with the reporting guidelines set out in the SAS Guidance; and (b) if the health practitioner becomes aware of a defect in the biological—notify the Therapeutic Goods Administration and the sponsor of the biological in accordance with the reporting guidelines set out in the SAS Guidance. Schedule 1—Biologicals authorised for supply Note: See section 5. Specified therapeutic goods Column 1 Column 2 Column 3 Column 4 Column 5 Item Biological Route of administration Indication Health practitioner 1 AlloDerm GBR RTM (human skin tissue matrix) intra-oral graft graft protection and containment, dental practitioner flap extender to achieve primary closure, or gingival augmentation 2 AlloDerm RTM (human skin tissue matrix) intra-oral graft root coverage, gingival augmentation dental practitioner soft tissue ridge augmentation, or soft tissue augmentation around implants 3 Amniotic Membrane ophthalmic ocular conditions medical practitioner 4 Grafton DBM Matrix (demineralised human bone tissue) intra-oral graft extraction socket grafting, ridge and sinus augmentation, bone augmentation around implants, bony defects, composite grafting, or filling of periodontal defects dental practitioner 5 MinerOss Cancellous (human bone allograft) intra-oral graft ridge and sinus augmentation, extraction socket grafting, or bony defects dental practitioner 6 MinerOss cortical and cancellous (human bone allograft) intra-oral graft ridge and sinus augmentation, extraction socket grafting, or bony defects dental practitioner 7 MinerOss Cortical (human bone allograft) intra-oral graft ridge and sinus augmentation, extraction socket grafting, or bony defects dental 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 9 Puros Cancellous Particulate Allograft (human bone tissue) intra-oral graft ridge and sinus augmentation, extraction socket grafting, or bony defects dental practitioner 10 Puros Cortical Particulate Allograft (human bone tissue) intra-oral graft ridge and sinus augmentation, extraction socket grafting, or bony defects dental practitioner 11 Tutoplast Pericardium (sterilised human tissue allograft) topical soft tissue graft medical practitioner Endnotes Endnote 1—About the endnotes The endnotes provide information about this compilation and the compiled law. The following endnotes are included in every compilation: Endnote 1—About the endnotes Endnote 2—Abbreviation key Endnote 3—Legislation history Endnote 4—Amendment history Abbreviation key—Endnote 2 The abbreviation key sets out abbreviations that may be used in the endnotes. Legislation history and amendment history—Endnotes 3 and 4 Amending laws are annotated in the legislation history and amendment history. The legislation history in endnote 3 provides information about each law that has amended (or will amend) the compiled law. The information includes commencement details for amending laws and details of any application, saving or transitional provisions that are not included in this compilation. The amendment history in endnote 4 provides information about amendments at the provision (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with a provision of the law. Misdescribed amendments A misdescribed amendment is an amendment that does not accurately describe how an amendment is to be made. If, despite the misdescription, the amendment can be given effect as intended, then the misdescribed amendment can be incorporated through an editorial change made under section 15V of the Legislation Act 2003. If a misdescribed amendment cannot be given effect as intended, the amendment is not incorporated and "(md not incorp)" is added to the amendment history. Endnote 2—Abbreviation key ad = added or inserted orig = original am = amended par = paragraph(s)/subparagraph(s) amdt = amendment /sub‑subparagraph(s) c = clause(s) pres = present C[x] = Compilation No. x prev = previous Ch = Chapter(s) (prev…) = previously def = definition(s) Pt = Part(s) Dict = Dictionary r = regulation(s)/rule(s) disallowed = disallowed by Parliament reloc = relocated Div = Division(s) renum = renumbered exp = expires/expired or ceases/ceased to have rep = repealed effect rs = repealed and substituted F = Federal Register of Legislation s = section(s)/subsection(s) gaz = gazette Sch = Schedule(s) LA = Legislation Act 2003 Sdiv = Subdivision(s) LIA = Legislative Instruments Act 2003 SLI = Select Legislative Instrument (md not incorp) = misdescribed amendment SR = Statutory Rules cannot be given effect Sub‑Ch = Sub‑Chapter(s) mod = modified/modification SubPt = Subpart(s) No. = Number(s) underlining = whole or part not o = order(s) commenced or to be commenced Ord = Ordinance Endnote 3—Legislation history Name Registration Commencement Application, saving and transitional provisions Therapeutic Goods (Biologicals—Authorised Supply) Rules 2022 16 Dec 2022 17 Dec 2022 — (F2022L01673) Therapeutic Goods (Medicines—Authorised Supply) Amendment (Vaping) Rules 2023 15 Dec 2023 1 Jan 2024 — (F2023L01683) Therapeutic Goods (Authorised Supply) Amendment (SAS Guidance) Rules 2024 6 Jun 2024 5 Jun 2024 — (F2024L00639) Therapeutic Goods (Authorised Supply) Amendment (SAS Guidance) Rules (No. 2) 2024 16 Oct 2024 17 Oct 2024 — (F2024L01321) Endnote 4—Amendment history Provision affected How affected s 2………………………………. rep LA s 48D s 4………………………………. am F2023L01683; F2024L00639; F2024L01321 s 6………………………………. rep LA s 48C Schedule 2……………………… rep LA s 48C