Human Tissue and Transplant Regulations 2024

The regulations revolve around definitional and cross-reference mechanics rather than standalone regulatory controls. The core statutory concepts used are drawn directly from the Human Tissue and Transplant Act 1982 and from the Commonwealth Therapeutic Goods Act as applied within the State framework. The regulations expressly address the following statutory concepts by naming or prescribing items for the Act to operate against.

• Exempt entity (s 29A(1) , reg 3). The regulations single out the Australian Bone Marrow Donor Registry (ACN 096 625 231) as an exempt entity for the purposes of the Act. The regulation is limited in scope: it does not itself define the legal effects of being an exempt entity. Those effects flow from s 29A of the Act; the regulation simply attaches the status to the named body.

• TG law provision / TGA provision / TG law provisions (reg 4). The regulations define "equivalent section" and "equivalent rule" to mean the sections and rules of the Therapeutic Goods Act that apply as State law under the Therapeutic Goods Law Application Act 2024 section 5 (for sections) and section 10 (for rules). The regulation then prescribes a list of specific Therapeutic Goods Act sections and rules that are to be treated as TG law provisions for the purposes of s 29A(4)(d) and (e) (reg 4(2) and 4(3)). The list includes, among others, Therapeutic Goods Act sections 19(1) and 19(5), sections in the 32C and 41H series, and associated rules made under specified subsections.

• Equivalent sections and rules (reg 4(1)). The concept of "equivalent section" and "equivalent rule" is a cross-jurisdictional mapping device. Each is defined by reference to their application as State law under the Therapeutic Goods Law Application Act 2024 and by equivalence to the Commonwealth provision.

• Tissue bank (s 29B(1) , reg 5). The regulation identifies two facilities as tissue banks: the Perron Rotary Express Milk Bank (PREM Bank) and the branch of Australian Red Cross Lifeblood responsible for donor human milk. The identification is for the purposes of the statutory definition in s 29B(1) of the Act.

• Body of medical practitioners (s 29E(3)(a) , reg 6). The Western Australian Kidney Transplant Society Medical Subcommittee is designated as a body of medical practitioners for the stated subsection.

• Repeal of the Human Tissue and Transplant Regulations 2006 (reg 7). The 2024 regulations repeal the previous regulations made in 2006.

These concepts function as inputs into the statutory machinery of the Human Tissue and Transplant Act 1982. The regulations do not, in themselves, create clinical standards or licensing conditions. Instead they alter who or what is captured or excluded from the Act’s existing provisions by naming entities and by specifying which Commonwealth therapeutic goods provisions should be treated as operative for the Act’s purposes. The definition of "equivalent section" and "equivalent rule" ties the operation of the Act to the Therapeutic Goods Law Application Act 2024, meaning the actual legal effect depends on the way the Commonwealth provisions are applied as State law under that Act.

The regulations produce immediate legal effects on a narrowly defined set of organisational actors and, indirectly, on persons and entities whose activities are regulated through the TG law provisions that are prescribed. Identify the groups affected as follows.

• Australian Bone Marrow Donor Registry (ABMDR). Reg 3 expressly designates the ABMDR (ACN 096 625 231) as an "exempt entity" for the purposes of s 29A(1). That statutory label will change how the ABMDR is treated under any Act provisions that turn on the s 29A(1) definition. The regulation identifies the specific corporate entity (ACN given), so the legal effect is limited to that entity.

• PREM Bank and Lifeblood donor human milk branch. Reg 5 designates the Perron Rotary Express Milk Bank (PREM Bank) and the branch of Australian Red Cross Lifeblood responsible for donor human milk as "tissue banks" for the purposes of s 29B(1). Those entities will be treated as tissue banks where the Act’s obligations, prohibitions or permissions hinge on that definition.

• Western Australian Kidney Transplant Society Medical Subcommittee. Reg 6 designates that body as a "body of medical practitioners" for s 29E(3)(a). Any statutory functions, consultative roles, approvals or decision-making processes in s 29E that require or recognise such a body will be satisfied by the named committee.

• Persons and businesses regulated by the prescribed TG provisions. Regulation 4 prescribes a set of Commonwealth Therapeutic Goods Act sections and rules that, via the Therapeutic Goods Law Application Act 2024, apply as State law and are to be treated as TG law provisions for the Act’s purposes (reg 4(2), 4(3), 4(1)). Entities that produce, supply, import, or otherwise handle therapeutic goods that fall within those specific Commonwealth provisions will be affected insofar as the Human Tissue and Transplant Act applies those TG law provisions domestically. The regulation also carves out certain Commonwealth regulations to the extent they apply to specified goods (reg 4(4)).

• Administrators of the Act and enforcement bodies. The departments or regulators charged with administering the Human Tissue and Transplant Act will need to apply the new definitions and prescribed TG law provisions. Operational processes, such as registry interactions or approvals, may need updating to reflect the designations and cross-references.

• Users of the repealed 2006 regulations. Entities that previously relied on the Human Tissue and Transplant Regulations 2006 must now rely on the 2024 regulations. Reg 7 repeals the earlier instrument.

The regulations do not establish new licensing fees, criminal offences, or explicit recordkeeping requirements themselves. They instead adjust which actors and external Commonwealth legal instruments are within the ambit of the Human Tissue and Transplant Act, thereby affecting the downstream application of the Act’s substantive provisions. The precise practical effects for each affected actor depend on how the Act’s named sections operate. For example, the ABMDR’s new status as an exempt entity will only impact ABMDR to the extent s 29A(1) confers or removes obligations or permissions; the regulation states the status but does not spell out those downstream rights or obligations.

The regulations do not themselves impose granular duties or create stand-alone rights. Instead they operate by attributing defined labels and by prescribing which Commonwealth therapeutic goods provisions are captured for the Act’s purposes. The key operative duties and rights to attend to are therefore those embedded in the Human Tissue and Transplant Act and in the specified Therapeutic Goods Act provisions that are applied as TG law provisions. Within the regulations themselves the consequential duties and rights arise as follows.

• Duty to treat the named entities under certain provisions of the Act. By designating the ABMDR as an exempt entity (reg 3), and by designating PREM Bank and the Lifeblood branch as tissue banks (reg 5), the regulations require administrators, courts and regulated parties to treat those named organisations as meeting the statutory labels in ss 29A and 29B. Any duties or rights that the Human Tissue and Transplant Act attaches to those labels therefore apply to the named organisations. The regulations themselves do not restate those duties or rights; they create the trigger that causes the Act’s pre-existing duties and rights to apply.

• Duty to apply prescribed TG law provisions as part of the Act’s framework. Regulation 4 prescribes specific sections and rules from the Therapeutic Goods Act (and their "equivalent" State counterparts) to be TG law provisions for the purposes of particular subsections of s 29A. Where the Act requires compliance with TG law provisions, those duties will be met by reference to the prescribed items in reg 4(2) and 4(3). The definitions in reg 4(1) link those references to the Therapeutic Goods Law Application Act 2024, so duties effectively attach to the Commonwealth provisions as they apply under that application Act.

• Right to be recognised as a "body of medical practitioners" for consultative or decision-making roles. Reg 6 designates the Western Australian Kidney Transplant Society Medical Subcommittee as such a body under s 29E(3)(a). Any statutory provisions that require consultation with, approval by, or recommendation from a "body of medical practitioners" will, by the regulation, recognise this specific body.

• Scope limits specified by reg 4(4). Regulation 4(4) narrows the reach of certain prescribed regulations by excluding their operation where they apply to a therapeutic good mentioned in the Commonwealth Therapeutic Goods Regulations 1990 Schedule 5 item 10. This is a rights/duties limiter: it prevents the TG law provisions listed at reg 4(3)(a) or (c) from being prescribed to the extent they apply to those specific goods. The effect is to confine the State-level prescription for those goods.

The regulations are a mechanistic instrument: they make statutory labels and references explicit so that the duties and rights embedded in the parent Act and in the referenced TG provisions can be applied without ambiguity as to which entities and which Commonwealth sections or rules are in scope. The regulations do not themselves create obligations such as registration fees, sanctioning regimes or clinical standards; those are supplied by the Act and the referenced TG law provisions. Therefore, to identify the precise duties and rights a practitioner must consult s 29A, s 29B, s 29E of the Human Tissue and Transplant Act and the Therapeutic Goods Act sections and rules listed in reg 4(2) and 4(3).

The 2024 Regulations contain no standalone penalty clauses, enforcement mechanisms, or compliance sanctions. Their operative function is declaratory and referential. That said, the regulations have enforcement relevance indirectly because they determine which entities and which external provisions are treated as within the Act’s regulatory perimeter. The enforcement implications therefore arise through the Act and the prescribed TG law provisions rather than through the regulations themselves.

• No penalties in the Regulations. The text of the Human Tissue and Transplant Regulations 2024 does not specify fines, imprisonment, administrative penalties, licensing suspensions, or specific enforcement authorities. The instrument is limited to definitions, designations and a repeal (regs 1-7). Consequently, any penal consequences must be traced to provisions of the Human Tissue and Transplant Act 1982 and to the Therapeutic Goods Act sections and rules prescribed by reg 4.

• Indirect enforcement through the Act and TG provisions. By designating certain entities and by prescribing particular TG law provisions as applicable, the regulations determine which persons, goods, or organisations fall into categories that may, under the Act, attract regulatory sanctions or administrative oversight. For example, if the Act contains offences or civil penalties tied to actions by a "tissue bank" or obligations that accessory persons must meet when TG law provisions apply, the named tissue banks (reg 5) and any regulated parties handling goods covered by the prescribed TG provisions (reg 4) will be within the enforcement field of those Act provisions.

• Carve-outs affecting enforcement scope. Regulation 4(4) limits the reach of certain regulations where they apply to therapeutic goods listed in the Commonwealth Therapeutic Goods Regulations 1990 Schedule 5 item 10. That carve-out narrows enforcement exposure under the TG law provisions prescribed by reg 4(3)(a) or (c) to the extent those provisions would otherwise apply to those goods. This is administratively significant because it changes which products or supplies may attract obligations, reporting duties, or sanctions via the State Act.

• Practical enforcement actors. The regulations do not identify the agencies that will enforce the Human Tissue and Transplant Act or the prescribed TG law provisions; those functions are set out in the parent Act and in other State administrative arrangements. Administrators must interpret and apply the prescribed TG provisions as they operate under the Therapeutic Goods Law Application Act 2024; the regulations therefore create work for enforcement bodies in mapping Commonwealth provisions into State practice.

In short, the Regulations themselves are non-punitive. Their enforcement significance is derivative: they adjust who and what the Act reaches, which in turn adjusts who can be subject to the Act’s statutory offences, civil penalties and administrative enforcement measures. Determining the concrete penalties and enforcement processes therefore requires reading the Human Tissue and Transplant Act and the specific Therapeutic Goods Act provisions listed at reg 4.

The regulations are explicitly designed to operate in conjunction with three categories of existing law: the Human Tissue and Transplant Act 1982 (WA) (the parent Act), the Commonwealth Therapeutic Goods Act 1989 and rules under that Act, and the Therapeutic Goods Law Application Act 2024 (WA) which applies Commonwealth TGA provisions as State law. The instrument creates cross-references and equivalences; it also repeals the prior 2006 regulations. Key interactions are as follows.

• Interaction with the Human Tissue and Transplant Act 1982. Each designation and prescription in the Regulations is expressed to be "for the purposes of" specific sections of the Act. Reg 3 refers to the definition of "exempt entity" in s 29A(1). Reg 4 explicitly references s 29A(4)(d) and (e) in prescribing what counts as TG law provisions. Reg 5 is expressly "for the purposes of the definition of tissue bank in section 29B(1)". Reg 6 is "for the purposes of section 29E(3)(a)". Therefore, application of the Regulations is inseparable from the parent Act. The Regulations do not stand alone; they populate the Act’s definitional slots so the Act may function as intended.

• Interaction with the Therapeutic Goods Act and rules made under it. Regulation 4 prescribes particular sections and rules of the Commonwealth Therapeutic Goods Act to be TG law provisions for the Act’s purposes (reg 4(2) and (3)). This results in the State Act relying on Commonwealth substantive provisions such as Therapeutic Goods Act sections 18A(1), 19(1), 32CK(1), 41HB(1), and specified rules. The Regulations also include the "equivalent section" and "equivalent rule" concept to capture the corresponding provisions that apply as State law under the Therapeutic Goods Law Application Act 2024 (reg 4(1)). The linkage means that changes at Commonwealth level to those sections or to the rules listed could alter the landscape of obligations referenced by the Human Tissue and Transplant Act as they are applied into State law, subject to the operation of the Therapeutic Goods Law Application Act 2024.

• Interaction with the Therapeutic Goods Law Application Act 2024 (WA). Regulation 4(1) ties the concept of "equivalent section" to sections 5 and 10 of the Therapeutic Goods Law Application Act 2024. That Act is the instrument by which Commonwealth therapeutic goods provisions are applied as State law. The Regulations therefore rely on an external instrument to give effect to the Commonwealth provisions; the State-level application is not accomplished directly by these Regulations but by the combination of these Regulations and the TGLAA 2024 framework.

• Carve-out referencing Commonwealth Regulations. Regulation 4(4) expressly excludes a regulation referred to in reg 4(3)(a) or (c) from the prescription where it applies to a therapeutic good mentioned in the Commonwealth Therapeutic Goods Regulations 1990 Schedule 5 item 10. This is an example of selective exclusion: the State prescription declines to import that Commonwealth regulation in respect of the listed goods. Practically this creates a divergence between the Commonwealth regime and the State’s application of it for particular items.

• Repeal of earlier Regulations. Reg 7 repeals the Human Tissue and Transplant Regulations 2006, signalling that entities and administrators must now apply the 2024 Regulations instead. Transitional or saving provisions would have to be checked in the Act or the repeal instrument if they exist; no such provisions are included in the text of the 2024 Regulations.

• Administrative cross-dependencies. Because these Regulations operate by identifying entities and by referring to Commonwealth provisions applied under a separate WA Act, administrators and regulated parties will need to consult three separate sources to understand their obligations: the Human Tissue and Transplant Act, the Therapeutic Goods Act provisions listed in reg 4 (as applied by the TGLAA 2024), and these Regulations. The Regulations are therefore a piece in a cross-jurisdictional legal architecture rather than a complete code.

The Regulations include a short amendment history, recorded in the notes and compilation table, and one explicit in-text amendment mention. The compilation table and embedded annotations are the sole sources of amendment information in the instrument provided.

• Original instrument and commencement. The Human Tissue and Transplant Regulations 2024 were published as SL 2024/10 and initially published on 9 February 2024. Regulations 1 and 2 (citation and commencement) came into effect on 9 February 2024, and the remainder of the regulations commenced on 19 February 2024 (see reg 2 and the compilation table entry for SL 2024/10).

• Later amending instrument SL 2024/276. The compilation table records an amending instrument titled Human Tissue and Transplant Amendment Regulations 2024, SL 2024/276, published 18 December 2024. The compilation table indicates r 1 and r 2 of that amending instrument commenced on 18 December 2024 and the remainder commenced on 19 December 2024. The body text contains a bracketed note indicating that regulation 4 was amended by SL 2024/276 r. 4, signposted in the main text at the end of reg 4: [Regulation 4 amended: SL 2024/276 r. 4.]. The nature of the amendment is not detailed in the legislative text reproduced here beyond that annotation; the compilation table is the only explicit record provided of the amendment instrument and its commencement dates.

• Repeal of the 2006 Regulations. Regulation 7 expressly repeals the Human Tissue and Transplant Regulations 2006. The effect is to replace the earlier regulatory instrument with the 2024 version. The text does not include transitional provisions or savings clauses; any transitional arrangements would need to be sought in the making instrument or the parent Act.

• Defined terms introduced. Regulation 4(1) introduces defined terms used in the 2024 Regulations , "equivalent rule", "equivalent section", "TGA provision", and "TG law provision" , which are relevant to understanding how subsequent amendments might interact.

The amendment annotation demonstrates that reg 4 was the target of at least one later amendment within the same calendar year. Anyone relying on these Regulations should consult the consolidated version on the WA legislation website (or the specific amending instrument SL 2024/276) to confirm the current text of reg 4 and the precise effect of the amendment. The compilation table confirms the publication and commencement chronology and flags that multiple instruments form the current compilation.

The Regulations as reproduced contain no litigation history, reported determinations, or named cases. The instrument itself is a made regulation and the text contains no references to court decisions, tribunal determinations, or legal disputes.

A few observations follow from the absence of litigation material in the text.

• No cases named in the instrument. The Regulations do not cite or rely on judicial interpretation. They are straightforward designations and cross-references and not the subject of reported litigation in the text supplied.

• Litigation would arise, if at all, in disputes about the effect of the Regulations when applying the Human Tissue and Transplant Act and the prescribed TG law provisions. For example, contentious questions could include whether an entity qualifies as an exempt entity under s 29A(1) despite the regulation’s designation, or whether particular goods fall within the scope of the Commonwealth provisions as applied under the Therapeutic Goods Law Application Act 2024. The Regulations themselves do not set out dispute-resolution arrangements.

• To identify any actual litigation that has arisen since commencement would require search of judicial and tribunal databases and checking the consolidated legislative record beyond the text provided. The instrument’s compilation notes and the absence of case law references indicate no reported litigation is attached to the Regulations in the material before us.

Because the Regulations operate principally by reference to other statutory instruments, disputes likely to generate litigation will typically involve interpretation of the parent Act, the Therapeutic Goods Act provisions as applied under the TGLAA 2024, or operational decisions by regulators implementing those combined frameworks. The Regulations themselves are short and declaratory, which reduces the scope for litigation about the Regulations alone, but increases reliance on litigation concerning the parent instruments.

Practitioners should watch for a small number of concrete traps and implementation frictions that arise from the regulations’ reliance on external instruments, narrow drafting, and selective carve-outs. The following items are drawn from the instrument’s text.

• Labels without context. The Regulations repeatedly say "for the purposes of" particular subsections of the Act (regs 3, 5, 6). The Regulations do not explain the legal consequences of those labels. To determine rights, obligations, or liabilities that flow from the designations, a user must read the relevant sections of the Human Tissue and Transplant Act (for example s 29A, s 29B, s 29E). The Regulation gives the label; the Act gives the consequences.

• Dependence on the Therapeutic Goods Law Application Act 2024. The definitions of "equivalent section" and "equivalent rule" in reg 4(1) tie interpretation to the Therapeutic Goods Law Application Act 2024 sections 5 and 10. Any changes to the application Act or to how Commonwealth provisions are applied in State law will affect the operational meaning of the terms used in reg 4. This creates a moving target: the prescription of TG law provisions depends on the broader Commonwealth‑to‑State application architecture.

• Prescribed list may not be exhaustive for all purposes. Regulation 4 prescribes specific sections and rules of the Therapeutic Goods Act (reg 4(2), 4(3)). If a party assumes that all Therapeutic Goods Act provisions are imported, that assumption would be incorrect; only the listed provisions (and their equivalents as applied under the TGLAA 2024) are prescribed for the purposes of s 29A(4)(d) and (e). Users must map precisely which Commonwealth provisions are specified and not assume a blanket importation.

• Carve-out creates divergence for certain goods. Regulation 4(4) excludes a regulation referred to in reg 4(3)(a) or (c) from the prescription to the extent it applies to a therapeutic good mentioned in the Commonwealth Therapeutic Goods Regulations 1990 Schedule 5 item 10. That selective exclusion can create differences between Commonwealth regulation and the State’s imported provisions for those goods. Entities dealing with goods that might fall into Schedule 5 item 10 should check whether the excluded regulation would otherwise have applied and adjust compliance expectations accordingly.

• Narrow entity naming risks omission or ambiguity. The Regulations name specific organisations by name and ACN in the case of the ABMDR. If a practitioner assumes broader classes are covered (for example, other bone marrow registries or milk banks), that assumption could be wrong. The designations are entity-specific. To avoid surprise, organisations should check whether they are the named entity or whether they need separate application or recognition.

• Repeal of prior regulations. The repeal of the 2006 Regulations (reg 7) may have altered transitional arrangements, exemptions, or operational definitions that previously applied. Unless transitional provisions are located elsewhere (for example in the Act or in the amending instrument), entities must verify whether any prior savings clauses survive repeal.

• Amendment note limited in detail. The text includes the annotation [Regulation 4 amended: SL 2024/276 r. 4.], and the compilation table records the amending instrument. The main text does not detail the amendment’s substance. Practitioners must consult the amending instrument SL 2024/276 or the consolidated online version to see the exact current wording of reg 4, especially because reg 4 ties the State framework to a cluster of Commonwealth provisions.

• No standalone enforcement rules or fees. Because the Regulations do not themselves set penalties or fees, parties should not look to the Regulations for enforcement detail. The enforcement regime will be found in the Act and in the prescribed TG provisions. Failure to consult those sources may lead to misreading compliance exposure.

In short, the principal "gotcha" is reliance on the Regulations in isolation. They are short and highly referential. The meat of regulatory obligations, enforcement and rights sits in the Human Tissue and Transplant Act and in the Commonwealth provisions that are imported by reference and by the Therapeutic Goods Law Application Act 2024. Workflows and legal advice must therefore map across instruments rather than treating the Regulations as a self-contained regulatory text.

Compliance is necessarily multi-instrument because the Regulations primarily attach labels and import specified Commonwealth therapeutics provisions. The following concrete steps will assist entities and administrators to establish compliance in light of the Regulations.

1. Map the statutory references. Identify the precise provisions of the Human Tissue and Transplant Act that the Regulations reference: s 29A(1), s 29A(4)(d) and (e), s 29B(1) and s 29E(3)(a). The Regulations function by populating those slots. Compliance planning must therefore start with reading the parent Act to identify obligations that attach to the labels the Regulations confer.

2. For named entities, check status and corporate identity. If you are the Australian Bone Marrow Donor Registry, confirm that your corporate identity matches ACN 096 625 231 and update governance, reporting and disclosure materials to reflect the new designation as an "exempt entity" under s 29A(1) (reg 3). PREM Bank and the Lifeblood donor milk branch should likewise verify their organisational identity against the labels in reg 5 and adjust internal compliance registers accordingly. For the Western Australian Kidney Transplant Society Medical Subcommittee, confirm internal terms of reference and membership to ensure the body matches expectations under s 29E(3)(a) (reg 6).

3. Identify which Therapeutic Goods Act provisions apply to your activities. Regulation 4(2) and 4(3) list the Therapeutic Goods Act sections and rules the Regulations prescribe as TG law provisions. Entities that manufacture, supply, import, or otherwise handle therapeutic goods should map their activities against those specific Commonwealth provisions. Note that "equivalent section" and "equivalent rule" mean the provisions as applied under the Therapeutic Goods Law Application Act 2024 (reg 4(1)); compliance therefore requires checking the State-applied equivalents as they currently stand under that application Act.

4. Pay attention to the carve-out in reg 4(4). If your goods potentially fall within the Commonwealth Therapeutic Goods Regulations 1990 Schedule 5 item 10, verify whether any regulation listed in reg 4(3)(a) or (c) would have applied to your goods and whether the exclusion instead removes that prescription. The carve-out can change your obligations under the State Act.

5. Update operational and regulatory documentation. Regulators and administrative staff administering the Human Tissue and Transplant Act should amend forms, guidance, and internal systems to reflect: the ABMDR’s exempt entity status (reg 3); the identity of tissue banks (reg 5); the recognition of the WA Kidney Transplant Society Medical Subcommittee (reg 6); and the set of prescribed TG law provisions (reg 4). Where processes reference "tissue bank" or "exempt entity", ensure they now recognise the specific organisations named.

6. Seek the consolidated and current texts. The Regulations contain an amendment note to reg 4 (amendment by SL 2024/276 r. 4) and the compilation table records commencement dates for both SL 2024/10 and SL 2024/276. Before finalising compliance assessments, consult the consolidated instrument on the WA legislation website to ensure you are working from the current text, particularly for reg 4 which has been amended.

7. Do not rely on the Regulations for enforcement detail. Because the Regulations do not contain penalty provisions or enforcement processes, compliance programmes must identify sanctioning provisions in the Human Tissue and Transplant Act and in the Commonwealth Therapeutic Goods Act sections and rules listed at reg 4(2) and 4(3). Ensure legal counsel reviews these instruments together to identify duties, reporting obligations and potential penalties.

8. Document regulatory reliance. Entities named in the Regulations should maintain documentation evidencing their reliance on the designation , for example, board minutes acknowledging exempt entity status or tissues bank designation, updated policies referencing the specific reg numbers, and a compliance register mapping statutory duties to operational controls.

9. Monitor external instruments. Because reg 4 ties the meaning of "equivalent section" and "equivalent rule" to the Therapeutic Goods Law Application Act 2024, and because the prescribed TG provisions are Commonwealth provisions applied as State law, monitor changes to the Therapeutic Goods Act, rules, the Commonwealth Regulations referenced, and to the Therapeutic Goods Law Application Act 2024. Changes in those instruments may change the obligations that the Human Tissue and Transplant Act imports.

10. If in doubt, get targeted legal advice. The Regulations are short but their practical effects are mediated through multiple statutes. A practical compliance review should combine the Regulations with s 29A, s 29B and s 29E of the Human Tissue and Transplant Act, the Therapeutic Goods Act sections and rules identified in reg 4, and the Therapeutic Goods Law Application Act 2024.

These steps are concrete and narrow because the Regulations themselves perform a limited function: naming specific entities and mapping specific Commonwealth provisions into the State Act’s framework. Compliance therefore requires cross-checking and cross-referencing rather than compliance with new stand-alone rules added by the Regulations.