Therapeutic Goods Law Application Act 2024

Applied therapeutic goods law: The statutory core is the concept of "applied therapeutic goods law," meaning those provisions that apply as State law because of ss 5 and 10 (s 3(1)). Section 5 imports the Commonwealth therapeutic goods Act as in force on 27 November 2023 and as further amended by qualifying amending Acts; section 10 imports therapeutic legislative instruments. The imported corpus applies "as part of this Act" (s 5(4)), thereby folding Commonwealth text into the WA statute book for relevant purposes.

Amending Acts and therapeutic legislative instruments: The Act distinguishes between (a) amending Acts, which are Commonwealth Acts that amend the Therapeutic Goods Act 1989 or make/amend therapeutic legislative instruments and which receive Royal Assent on or after 27 November 2023 (s 3(1)), and (b) therapeutic legislative instruments, which are regulations or other legislative instruments made under the Commonwealth Act (s 3(1), s 10). Amending Acts and those instruments have a two‑stage treatment: they can only take effect in WA if they comply with the Act’s tabling and disallowance procedures (ss 6-8 and 11-13).

Parliamentary oversight and disallowance: The Act builds a State parliamentary oversight layer for Commonwealth changes. Amending Acts must be tabled in both Houses within 18 sitting days (s 6). There is a prescribed notice and disallowance process , notice period 14 sitting days, disallowance period 30 sitting days , and an amending Act only has effect in WA if no disallowance resolution is successful (s 7). For instruments, there is a publication requirement within 18 days (s 12(2)) and a tabling requirement within six sitting days (s 13(2)). Instruments cease to have effect in WA if they are not published, not laid or disallowed (s 13(3)).

Interpretation and administrative law mapping: The Act removes the WA Interpretation Act 1984 from the interpretive regime for applied therapeutic goods law and brings in Commonwealth interpretation laws (s 14(2)-(3)). It also applies specified Commonwealth administrative laws as laws of the State in relation to matters arising under the applied therapeutic goods law, including FOI, Privacy, Ombudsman and AAT statutes (s 22(1)). However, a provision of those Commonwealth administrative laws that purports to confer federal-court jurisdiction is taken not to have that effect in WA (s 22(4)). Additionally, references in Commonwealth law to Part IVA of the AAT Act are to be read as they have effect at the Commonwealth level (s 22(5)).

Enforcement and criminal treatment: The Act’s Part 4 treats offences against the applied therapeutic goods law as if they were offences against Commonwealth law for a swathe of purposes relevant to criminal procedure, investigation, sentencing, infringement notices, proceeds of crime and spent convictions (s 18). Section 19 applies "relevant Commonwealth criminal laws" as laws of the State and directs that, for State law purposes, an offence against the applied therapeutic goods law is taken to be an offence against laws of the Commonwealth and not an offence against State laws (s 19(2)-(3)). The Act also extends functions and powers to Commonwealth authorities and officers in relation to offences (s 20) and expressly prevents double jeopardy where the person has already been punished under the corresponding Commonwealth provision (s 21).

Local modifications and State discretion: Local regulations are the primary mechanism for WA to modify the applied therapeutic goods law (ss 15, 26). The Governor may make regulations required or permitted by the Act or necessary or convenient to give effect to the Act or the applied therapeutic goods law (s 26). Local regulations may modify the applied law generally (s 15) and may, by implication, carve out exceptions or adjust procedural aspects (see s 19(4) and s 22(3), which preserve the possibility of local regulations to affect the effect of s 19 and s 22).

Delegation and Commonwealth authorities: Delegations made under the Commonwealth therapeutic goods law at the Commonwealth level "are taken to extend to" the corresponding provisions of the applied therapeutic goods law (s 17). Commonwealth authorities and officers who are referred to in the applied therapeutic goods law "have the same functions and powers under the applied therapeutic goods law as they have under the Commonwealth therapeutic goods law, as that law applies to the Commonwealth" (s 16). Commonwealth administrative statutes that confer functions or powers on Commonwealth authorities also apply to matters under the applied therapeutic goods law (s 23).

Fiscal allocation and fees: Fees payable in connection with the performance of functions or exercise of powers under the applied therapeutic goods law "may" be retained by the Commonwealth, a Commonwealth authority or Commonwealth officer (s 24). The Act therefore preserves an arrangement where revenue generated under the applied law may flow to Commonwealth coffers rather than to the State.

Transitional architecture: The Act defines a commencement regime (s 2) and contains transitional provisions for amending Acts and instruments enacted on or after 27 November 2023 but before commencement (ss 28-29), a two‑year protected period for persons lawfully dealing with therapeutic goods immediately before commencement (s 30), and a transitional regulation-making power limited to two years after commencement (s 31).

Consequential amendments: The Act makes limited textual changes to the Human Tissue and Transplant Act 1982 and the Medicines and Poisons Act 2014 to reflect the imported therapeutic goods law (Part 8, ss 32-38), substituting defined terms so existing WA licensing and offence regimes reference "therapeutic goods law" (as defined).

These core concepts interact to create a hybrid regime in which Commonwealth content governs the substantive regulation of therapeutic goods in WA, subject to a State layering of tabling, disallowance and modification through local regulations, with Commonwealth administrative and criminal frameworks imported for comparable procedural and enforcement purposes.

The Act affects multiple categories of actors by importing Commonwealth therapeutic goods law into WA. First, entities and persons who, under the Commonwealth Therapeutic Goods Act 1989 and its instruments, are regulated in relation to therapeutic goods now find those Commonwealth rules operating as State law (s 5(2)-(4); s 10(1)). The Act itself does not enumerate named industry classes, but by definition the applied therapeutic goods law is the body of Commonwealth provisions that regulate therapeutic goods and the persons to whom those provisions apply. Practitioners should therefore treat all persons and businesses subject to TGA requirements , manufacturers, sponsors, importers, suppliers, advertisers, clinical trial sponsors, and persons dealing with therapeutic goods , as within the scope of the applied law, because the Act makes that Commonwealth content part of the State statute book (s 5(4), s 10(1)).

Second, Commonwealth authorities and officers referred to within the applied therapeutic goods law acquire, under the Act, functions and powers in WA in relation to the applied law "as if" they had those functions and powers at the Commonwealth level (s 16). This means enforcement and regulatory action in WA may be taken by Commonwealth bodies or officers exercising powers in respect of applied State law (s 20, s 23). Delegations made under Commonwealth law are taken to extend to the corresponding State provisions (s 17), which can affect who makes regulatory decisions or conducts inspections in WA.

Third, the Western Australian Parliament, through its tabling and disallowance mechanisms, becomes a gatekeeper for amending Commonwealth provisions and for therapeutic legislative instruments to operate in WA. Amending Acts must be laid before each House within prescribed times (s 6), and instruments must be published and laid before Parliament or they cease to have effect (ss 12-13). Members of the WA Parliament, parliamentary committees (s 9), and the parliamentary process therefore become relevant actors in determining whether particular Commonwealth changes take effect within WA.

Fourth, the State executive and regulators are affected in two ways. The Governor may make local regulations to modify the applied therapeutic goods law (ss 15, 26). The State must also accommodate the importation of Commonwealth interpretation and administrative law regimes (s 14, s 22), which affects how State bodies interpret and administer applied provisions. Local regulators who administer Medicines and Poisons licences, human tissue controls and similar WA statutory frameworks are directly affected by the consequential amendments to the Human Tissue and Transplant Act 1982 and the Medicines and Poisons Act 2014 that incorporate the applied therapeutic goods law into WA definitions and licensing tests (Part 8, ss 32-38).

Fifth, the criminal justice system and administrative review bodies may be affected. Part 4 treats offences under the applied therapeutic goods law as if they were Commonwealth offences for purposes of investigation, prosecution, arrest, bail and sentencing (ss 18-19). Commonwealth criminal laws will therefore apply to offences, and relevant Commonwealth authorities and officers have corresponding functions and powers in relation to these offences (s 20). Simultaneously, Commonwealth administrative laws such as the Administrative Appeals Tribunal Act, FOI Act, Ombudsman Act and Privacy Act apply as laws of the State in relation to matters arising under the applied therapeutic goods law (s 22), meaning affected persons have rights and processes under those Commonwealth statutes in relation to decisions and actions under the applied law.

Sixth, the financial flows are affected. Fees paid in respect of functions or powers under the applied therapeutic goods law may be retained by the Commonwealth (s 24). That alters which level of government benefits financially from regulatory activity and has implications for State budgeting, industry cost allocation and whoever pays licence or application fees.

Seventh, individuals and businesses engaged in pre-existing conduct immediately before commencement , the "transitioned conduct" , are temporarily affected by the two‑year limited immunity: for two years beginning on commencement day, the person may continue the transitioned conduct and does not contravene the applied therapeutic goods law by engaging in it (s 30(2)). Practitioners advising clients should identify whether pre‑commencement conduct falls within that safe harbour and the date of commencement (s 27-30).

Finally, Parliamentarians, parliamentary committees and legal advisers who must monitor the tabling, notice, and disallowance periods for amending Acts and instruments are affected because their timely action can prevent or allow Commonwealth changes to take effect in WA (ss 6-8, 12-13). In sum, the Act affects regulated persons and businesses, Commonwealth and State authorities, WA Parliament and committees, the legal and compliance community, and those involved in criminal and administrative enforcement and review.

Duties to comply with applied therapeutic goods law: The primary duty created by the Act is the obligation to comply with the Commonwealth therapeutic goods Act and therapeutic legislative instruments as they apply in Western Australia (s 5(2); s 10(1)). Once a Commonwealth provision or instrument applies as State law under the mechanics set out in Parts 2 and 3, regulated persons are bound by that instrument as part of the State’s statute law, because the applied provisions "apply as a part of this Act" (s 5(4)) and therapeutic legislative instruments apply "as subsidiary legislation for the purposes of this Act" (s 10(4)).

Publication and tabling duties affecting validity: There are procedural duties indirectly affecting the validity of instruments. Therapeutic legislative instruments made on or after 27 November 2023 require publication no later than 18 days after they are made (s 12(2)), and must be laid before each House within six sitting days after publication or notice (s 13(2)). Failure to publish or lay an instrument means it ceases to have effect in WA (s 13(3)(a)-(b)). Amending Acts must be laid before each House within 18 sitting days (s 6), and will only take effect in WA if they survive the disallowance mechanism (s 7). Practitioners therefore have a duty to verify publication and tabling when relying on the operative status of amendments and instruments.

Rights to administrative review and access: The Act brings several Commonwealth administrative laws to bear as laws of the State in relation to matters arising under the applied therapeutic goods law (s 22(1)). That means affected persons have rights under the Administrative Appeals Tribunal Act 1975 (excluding Part IVA), the Freedom of Information Act 1982, the Ombudsman Act 1976 and the Privacy Act 1988 to seek review, information, and oversight in relation to matters arising under the applied law (s 22(1)). The Act preserves the content of those Commonwealth administrative statutes, but also states that a provision that purports to confer federal court jurisdiction is taken not to have that effect in WA (s 22(4)).

Enforcement and procedural rights in criminal matters: Part 4 sets out that offences against the applied therapeutic goods law are to be treated, for many purposes, as offences against Commonwealth law (s 18). The relevant Commonwealth criminal laws apply as laws of the State (s 19(2)). For persons accused of offences, this affects the procedural and substantive rules that apply to investigation, arrest, custody, bail, trial and sentencing (s 18(2) enumerates these purposes). The Act protects against double jeopardy where an individual has been punished under the corresponding Commonwealth provision (s 21). However, s 19(3)(b) provides that, for the purposes of a law of the State, the offence is taken not to be an offence against the laws of the State, which alters how State courts and agencies must treat such offences.

Delegation and powers of Commonwealth officers: Commonwealth authorities and officers referenced in the applied therapeutic goods law carry the same functions and powers in the State as they hold at the Commonwealth level (s 16). Delegations under Commonwealth law extend to the corresponding State provisions (s 17). Section 20 extends functions and powers conferred by Commonwealth law in relation to offences to Commonwealth authorities and officers in WA, and requires them to act "as nearly as practicable" in the same way as they would under the Commonwealth therapeutic goods law.

Fee and revenue rights: The Commonwealth may retain fees payable or recovered in respect of functions or powers performed under the applied therapeutic goods law (s 24). A practical consequence is that regulated parties paying application or licence fees under applied provisions can expect payment to go to the Commonwealth rather than to the State, where those fees are within the scope of s 24.

Local regulation and State modification rights: The Governor may make local regulations that modify the applied therapeutic goods law (s 15; s 26). That gives the State executive a right to adjust the imported Commonwealth law within the State’s competence. Subsection 19(4) and subsection 22(3) make clear that the application of ss 19 and 22 can be qualified by local regulations, so the State has a mechanism to alter how Commonwealth criminal and administrative laws apply in the WA context.

Transitional protections: Persons who engaged in conduct immediately before commencement that was lawful then but would contravene the applied therapeutic goods law on commencement day are granted a two‑year period in which they may continue the conduct without contravening the applied therapeutic goods law (s 30(1)-(2)). This is a time‑limited compliance right that requires parties to plan for alignment with the applied law once the two‑year window ends.

Parliamentary oversight rights: Members of the WA Parliament have rights to scrutinise amending Acts and therapeutic legislative instruments by invoking notice of disallowance resolutions (ss 6-8, 12-13). Parliamentary committees may be engaged by Standing Orders where applicable, since laying an amending Act is taken to be publication for the purposes of Standing Orders (s 9), and instruments are subject to tabling and disallowance (s 13).

These duties and rights create a mixed regulatory environment: substantive Commonwealth regulatory rules govern conduct, but a range of procedural duties, domestic review rights and State-level modification powers mediate how those rules are applied inside WA.

Criminal and civil hybrid treatment: Part 4 sets out that offences under the applied therapeutic goods law are to be treated, for purposes listed in s 18(2), as if they were offences against Commonwealth law. Section 18 expressly includes contraventions for which civil penalties may be imposed within the definition of "offences" for the Part (s 18(3)). This means both criminal offences and civil penalty contraventions under the applied therapeutic goods law are caught by the Act’s enforcement architecture.

Application of Commonwealth criminal laws: Section 19 applies "relevant Commonwealth criminal laws" , defined as Commonwealth laws relating to the purposes detailed in s 18(2) , as laws of the State in relation to offences against the applied therapeutic goods law (s 19(2)). For the purposes of a law of the State, an offence against the applied therapeutic goods law is taken to be an offence against the laws of the Commonwealth, and is taken not to be an offence against the laws of the State (s 19(3)(a)-(b)). That legal fiction has practical enforcement consequences: the procedural and substantive categories tied to Commonwealth criminal laws will govern investigation, arrests, custody, bail, trial, conviction, sentencing, fines, forfeitures, infringement notices, reparation, proceeds-of-crime proceedings and spent convictions (s 18(2) lists these purposes).

Powers of Commonwealth authorities and officers: Section 20 provides that any Commonwealth law which, by reason of s 19, confers a function or power on a Commonwealth authority or officer in relation to offences under Commonwealth therapeutic goods law also confers the same function or power in relation to offences against the corresponding provision of the applied therapeutic goods law. The officers and authorities must act "as nearly as practicable" as they would under the Commonwealth law (s 20(2)). Section 16 likewise confers the same functions and powers on Commonwealth authorities and officers as they possess for the Commonwealth therapeutic goods law (s 16). Practically, Commonwealth investigators and enforcement officers may exercise powers in WA under the applied law.

Double jeopardy protection: Section 21 ensures that where the same act or omission is both an offence under the applied therapeutic goods law and an offence under the corresponding Commonwealth provision, and the offender has already been punished under the Commonwealth provision, the offender is not liable to be punished under the applied therapeutic goods law (s 21(1)-(2)). This avoids duplicative punishment where Commonwealth proceedings have been taken.

Administrative enforcement and review: Commonwealth administrative laws apply to matters arising under the applied therapeutic goods law (s 22(1)). Affected persons therefore have access to mechanisms such as AAT review (subject to the exclusions in s 22(4) and the Act’s own references to Part IVA), FOI, Ombudsman oversight and Privacy Act protections in respect of administrative decisions affecting them under applied law (s 22). Section 23 extends functions and powers conferred by those Commonwealth administrative laws on Commonwealth authorities and officers in the applied-law context.

Limitations and State court jurisdictional note: Section 22(4) declares that a provision of a Commonwealth administrative law that purports to confer jurisdiction on a federal court is taken not to have that effect. Consequently, while the Commonwealth administrative statutes apply as laws of the State, their operation is trimmed to prevent an automatic transfer of judicial or federal-court jurisdiction simply through those statutes applying in the WA context.

Instrument invalidity and parliamentary disallowance: Therapeutic legislative instruments that fail procedural publication and tabling requirements or are disallowed cease to have effect in WA (s 13(3)-(4)). This can remove the substantive basis for particular offences or compliance obligations if the instrument is the source of a provision. Section 13(6) also provides a revival mechanism for instruments that were amended or repealed by a now-disallowed instrument: the earlier instrument revives for its application in WA the day after the disallowance takes effect.

Fee recovery and proceeds: The Commonwealth may retain fees paid to or recovered by the Commonwealth, a Commonwealth authority or officer in respect of their functions under the applied therapeutic goods law (s 24). The Act does not set WA-specific penalty revenue collection mechanisms for these fees; revenue may be directed to Commonwealth authorities.

Local regulations may alter enforcement treatment: Sections 19(4) and 22(3) allow for local regulations to limit or qualify the effect of ss 19 and 22. That creates a pathway for the State to change, by regulation, how Commonwealth criminal and administrative laws apply in the WA context (subject to the limits in s 26 and the State’s legislative power).

Practical enforcement implication: Enforcement in WA may be carried out by Commonwealth authorities exercising functions under Commonwealth laws applied as State law; offences will, for many procedural and substantive purposes, be governed by Commonwealth criminal law treatments; and affected persons will have recourse to Commonwealth administrative review and oversight mechanisms, but not to federal court jurisdiction automatically. The operation of local regulations, the two‑year transition period and parliamentary disallowance rights will affect the timing and scope of enforcement risk.

Interpretation law interaction: The Act replaces the usual operation of the WA Interpretation Act 1984 for the applied therapeutic goods law. Section 14(2) provides that the Interpretation Act 1984 does not apply to the applied therapeutic goods law; section 14(3) stipulates that Commonwealth interpretation laws apply as laws of the State "in relation to the interpretation of the applied therapeutic goods law" and "as if the applied therapeutic goods law were a Commonwealth Act or were a legislative instrument under a Commonwealth Act". Practically, this means interpretive aids, definitions, time computation rules and other statutory construction principles in Commonwealth Acts Interpretation Act 1901 and other Commonwealth interpretation materials will guide how courts and decision‑makers construe the applied therapeutic goods law in WA.

Administrative law overlay: The Act imports specified Commonwealth administrative laws as laws of the State in relation to matters arising under the applied therapeutic goods law (s 22(1)). These are the Administrative Appeals Tribunal Act 1975 (excluding Part IVA), the Freedom of Information Act 1982, the Ombudsman Act 1976 and the Privacy Act 1988 (s 3(1) lists these as "Commonwealth administrative laws"). The importation operates by deeming the matter to be one arising under Commonwealth laws for the purposes of those Acts (s 22(2)), but subsections 22(3)-(5) and s 14 contain qualifications. Section 22(4) ensures that the application of a Commonwealth administrative law in this way does not automatically confer jurisdiction on a federal court. Section 22(5) addresses references to Part IVA of the Administrative Appeals Tribunal Act, treating them as references to the Part as it has effect at the Commonwealth level.

Criminal law and procedure: Part 4 aligns offences against the applied therapeutic goods law with Commonwealth criminal laws related to the purposes enumerated in s 18(2). Section 19(2) applies relevant Commonwealth criminal laws as laws of the State, and s 19(3) instructs that an offence against the applied therapeutic goods law is taken to be an offence against Commonwealth laws and not State laws, for purposes of State law. This creates a cross‑jurisdictional fiction that treats the substantive offence as Commonwealth for many procedural purposes while still being part of the State statute book by virtue of s 5(4).

Federal‑State mix and local modification: The Act creates a hybrid legal structure in which Commonwealth content applies as State law, but the State retains the power to modify that applied law by local regulations (s 15; s 26). Subsections 5(3)(a)-(b) state that the Commonwealth therapeutic goods Act applies as modified by local regulations and "as if it extended to matters in relation to which the State may make laws", even where the Commonwealth may not have legislative competence in those areas (s 5(3)(b)). This provision effectively allows WA to extend the applied Commonwealth provisions into State domains, subject to the drafting and limits of local regulations.

Consequential interaction with State Acts: The Act amends WA statutes so that existing State licensing and offence frameworks refer to the applied therapeutic goods law. The Human Tissue and Transplant Act 1982 and the Medicines and Poisons Act 2014 are amended to insert definitions or replace references so that the TGA definition and transferred State definition of "therapeutic goods law" are used in place of previous references (Part 8, ss 32-38). As a result, WA licensing and regulation frameworks will cross‑refer to the applied Commonwealth law for definitions, licensing tests and potentially offence triggers.

Publication, tabling and parliamentary procedures: The Act imposes procedural requirements on the publication and tabling of Commonwealth amending Acts and therapeutic legislative instruments in the WA Parliament (ss 6-8, 12-13). Section 9 links the laying of amending Acts to Standing Orders’ publication requirements for referral to parliamentary committees, unless the Standing Orders specifically provide otherwise. Therefore, Commonwealth law changes may trigger State parliamentary processes for scrutiny, with implications for legislative monitoring and oversight.

Allocation of fees and financial interaction: The Commonwealth may retain fees collected under the applied therapeutic goods law (s 24). Although the applied provisions operate in WA, fee income may flow to the Commonwealth rather than to WA agencies, which is an intergovernmental financial interaction with budgetary effects for both levels of government and for regulated parties who pay the fees.

Reference mapping across laws: Section 25 provides that references in Commonwealth law to a provision of another law are to be read as references to that provision "as applying because of" ss 19 and 22 for the purposes of those sections. This direction is designed to ensure that cross‑references within Commonwealth statutes bind coherently when those statutes are applied as State law under ss 19 and 22.

Transitional and temporal interaction: The Act addresses temporal interactions between Commonwealth enactments and the WA application regime. Amending Acts and therapeutic legislative instruments enacted or made between 27 November 2023 and WA commencement are treated as if they occurred on commencement day for the purposes of publication and tabling rules (ss 28-29). The two‑year transitional safe harbour (s 30) and the transitional regulation power limited to two years (s 31) create a time‑limited overlap between pre‑existing lawful conduct under WA rules and the new applied Commonwealth provisions.

In short, the Act establishes detailed cross‑references and procedural rules designed to make Commonwealth therapeutic goods law operate inside WA, while simultaneously providing mechanisms for WA to interpret, modify and subject those provisions to State parliamentary scrutiny and to reconcile them with State legislation and administrative processes.

Foundational timeline: The Act received Royal Assent on 14 May 2024 (compilation table). Part 1, covering preliminary matters including short title and commencement framework, commenced on the day of Royal Assent (s 2(a)); the remainder of the Act came into operation by proclamation on 30 August 2024 (s 2(b); SL 2024/177 cl. 2). The Act uses 27 November 2023 as a statutory baseline date to determine which version of the Commonwealth Therapeutic Goods Act is imported (s 5(1)) and the definition of "amending Act" covers Commonwealth Acts that receive Royal Assent on or after that date and which amend the Commonwealth Act or make/amend therapeutic legislative instruments (s 3(1)).

Treatment of amending Acts enacted close to commencement: Sections 6-8 create a mechanism for amending Acts to take effect in Western Australia only after particular parliamentary procedures are followed. Section 6 requires that an amending Act be laid before each House of the WA Parliament within 18 sitting days after Royal Assent. Section 7 prescribes notice and disallowance periods (notice period 14 sitting days; disallowance period 30 sitting days) and states that an amending Act has effect in the State only if laid and either no notice of a disallowance resolution is given within the notice period or any disallowance resolution given is withdrawn or fails within the disallowance period (s 7(2)). Section 8 requires the Governor to proclaim that an amending Act has effect for the purposes of the Part as soon as practicable and prescribes how the commencement of provisions of an amending Act is to be aligned to Commonwealth commencement dates (s 8(1)-(3)). Transitional section 28 treats amending Acts that receive Royal Assent on or after 27 November 2023 but before commencement day as if they received Royal Assent on commencement day for the purposes of ss 6-8.

Treatment of instruments made close to commencement: Section 12 sets a publication deadline of no later than 18 days after the day on which a therapeutic legislative instrument made on or after 27 November 2023 is made (s 12(2)). Section 29 treats therapeutic legislative instruments made on or after 27 November 2023 but before commencement day as if they were made on commencement day for the purposes of s 12(2). Section 13 establishes a tabling requirement within six sitting days after publication and provides that failure to publish or to lay the instrument, or the instrument being disallowed by Parliament, will cause the instrument to cease to have effect in WA (s 13(3)-(4)). Section 11 contains an additional timing rule for instruments that are made under or for purposes of provisions inserted into the Commonwealth Act by amending Acts: such instrument provisions do not have effect in WA until both the amending Act provision has come into operation for WA (under s 8) and the instrument provision has come into operation in the Commonwealth (s 11(2)-(3)).

Substantive adjustments by WA legislation: Part 8 contains consequential amendments to WA statutes. Division 1 amends the Human Tissue and Transplant Act 1982 to add a TG law provision definition and to replace references to a TGA provision with the new TG law provision term (ss 32-33). Division 2 amends the Medicines and Poisons Act 2014, inserting a definition of "therapeutic goods law" that includes the applied therapeutic goods law (s 35) and amending several sections that previously referenced the Commonwealth Therapeutic Goods Act to refer instead to "therapeutic goods law" (ss 36-38). These textual amendments reconcile state statutory references with the new imported law.

Transitional regulation-making and savings: Section 31 authorises transitional local regulations to address matters of a transitional, savings or application nature arising from enactment. The power is time-limited to two years beginning on commencement day (s 31(3)), and subsection (5) protects rights and liabilities of persons (other than the State) existing before publication day of transitional regulations. Section 30 provides a two‑year safe harbour for persons engaged in transitioned conduct immediately before commencement who would otherwise commit contraventions under the applied law.

No express prior amendments recorded in the text: The Act’s defined terms section (s 3(1)) and Part 2 make clear that the Commonwealth Therapeutic Goods Act is imported as it was in force on 27 November 2023 together with certain amending provisions; the Act itself therefore creates a static baseline plus a dynamic mechanism for subsequent Commonwealth amending Acts to be incorporated into WA law subject to WA parliamentary procedure. The compilation table attached to the Act records its assent and commencement dates and the Statutory Rules entry establishing the proclamation (SL 2024/177 cl. 2) that brought the main body into effect on 30 August 2024.

Practical note for users: Effective dates for particular provisions in the applied corpus depend on Commonwealth commencement dates and the WA proclamation and tabling/disallowance processes (s 8). Practitioners and regulated parties must track both Commonwealth commencement and the WA tabling/disallowance and publication timelines to know when a change becomes operative in WA.

The Act text itself contains no reported case law or litigation history. It does not name any judicial decisions or administrative determinations, nor does it record disputes about its provisions. The Act provides procedural rules while leaving courts and tribunals to interpret and apply the imported Commonwealth text, Commonwealth interpretation laws and the Act’s transitional and modification provisions.

Areas likely to give rise to litigation or judicial scrutiny (based on the Act’s structural design) include:

• Jurisdictional and interpretive questions about the status of provisions that are treated simultaneously as Commonwealth content and as part of a WA Act. Section 5(4) declares applied Commonwealth provisions "apply as part of this Act," while ss 14 and 19 create interpretive and legal fictions that Commonwealth interpretation and criminal laws apply "as if" the applied therapeutic goods law were Commonwealth law. Disputes may arise over the application of Commonwealth interpretation laws to State courts and how to reconcile Commonwealth and WA statutory construction principles in particular cases.

• The effect of s 19(3), which directs that an offence against the applied therapeutic goods law is taken not to be an offence against the laws of the State for the purposes of a law of the State. Courts may be asked to resolve how this interacts with WA procedural rules and sentencing frameworks, and whether certain State actors retain role or standing in prosecutions.

• The boundary between Commonwealth and State competence under s 5(3)(b): the applied therapeutic goods Act "applies as if it extended to matters in relation to which the State may make laws … whether or not the Commonwealth may make laws in relation to those matters." Litigation could test whether particular regulatory extensions are within State power and how that interacts with Commonwealth content.

• Validity and application of local regulations that modify applied Commonwealth law under ss 15 and 26. Challenges may concern whether a local regulation remains within State competence or is inconsistent with the Commonwealth provision in a way that would raise federal inconsistency issues.

• Procedural validity of therapeutic legislative instruments and amending Acts in WA: the tabling, publication and disallowance mechanics in ss 6-8 and 12-13 create points at which parties may litigate whether an instrument was properly in force in WA at a given time (for example, where a regulated person relies on an instrument that was later disallowed).

• The two‑year transition carve-out in s 30 may generate litigation on whether particular conduct qualifies as "transitioned conduct" and whether the protective period applies to particular persons or activities.

The Act’s explicit statutory directions (for example, s 22(4) excluding federal court jurisdiction and s 21's double jeopardy protection) seek to limit certain routes to litigation and frame how disputes are to be treated procedurally. However, the Act creates a hybrid legal regime where Commonwealth and State legal forms are interlaced, and that hybridity is the primary structural reason why litigation in areas noted above would be foreseeable. Because the Act text does not provide a litigation record, practitioners should consult contemporary case law and administrative decisions post‑enactment to identify actual litigation trends and outcomes.

1. The Commonwealth interpretation regime replaces WA interpretation rules for the applied law (s 14). This is more than a technicality: familiar WA interpretive presumptions, time computation rules and defined-term cross-references in the Interpretation Act 1984 do not apply to the applied therapeutic goods law. Instead, Commonwealth interpretation laws apply "as if the applied therapeutic goods law were a Commonwealth Act" (s 14(3)). Practitioners must not assume WA interpretive practice will control and should check Commonwealth interpretation provisions.

2. Fees may be retained by the Commonwealth (s 24). The Act permits the Commonwealth to retain fees paid in respect of functions or powers performed under the applied law. Regulated parties should not assume that fee income will necessarily support WA regulatory budgets or services.

3. Publication and tabling are determinative of an instrument’s State effect (ss 12-13). Therapeutic legislative instruments made on or after 27 November 2023 must be published within 18 days (s 12(2)) and laid within six sitting days (s 13(2)). Failure to meet these steps leads to cessation of effect in WA (s 13(3)). A practitioner relying on a Commonwealth instrument should verify WA publication and tabling to ensure it actually operates locally.

4. An amending Act may pass Commonwealth Parliament but still be disallowed in WA (ss 6-8). Even after Royal Assent at the Commonwealth level, an amending Act only takes effect in WA for the purposes of this Act if it is laid in WA and survives the State disallowance mechanics (s 7). The commingling of Commonwealth and State lawmaking timelines can lead to uncertainty about when a Commonwealth amendment actually applies in WA.

5. Local regulations can modify imported law (ss 15, 26). The State can modify the applied therapeutic goods law by local regulations. Modifications can affect scope, procedural detail and possibly which Commonwealth administrative or criminal mechanisms apply in WA (ss 19(4), 22(3)). Do not assume the applied law will operate identically to the Commonwealth regime in all respects.

6. The Act imports Commonwealth administrative laws but limits federal judicial access (s 22). Although FOI, AAT review (subject to Part IVA exclusions), Ombudsman and Privacy protections apply as laws of the State (s 22(1)), the Act specifically prevents a Commonwealth administrative law provision from having the effect of conferring federal court jurisdiction in WA (s 22(4)). The practical consequence can be divergence in judicial pathways for review.

7. Delegations are taken to extend (s 17). Delegations made by Commonwealth officials under Commonwealth law are taken to extend to corresponding State provisions. That affects who may exercise regulatory functions in WA; it is important to map which delegated officials or agencies will carry out operational activities and how accountability channels will operate.

8. Criminal-law fiction: offences are treated as Commonwealth offences for many purposes (s 19). For State law purposes, an offence against the applied therapeutic goods law is taken to be an offence against Commonwealth laws and not State laws (s 19(3)). This can complicate how State prosecutorial machinery fits with the enforcement regime and how sentencing or ancillary orders are framed.

9. The two‑year transition immunity is narrow (s 30). Section 30 protects persons who "dealt with or used therapeutic goods immediately before commencement day" in a lawful manner, for two years. The immunity is time-limited and narrowly framed to conduct that was lawful immediately before commencement; it does not create a general grandfathering for all prior activities.

10. Revival mechanism for repealed instruments (s 13(6)). If a therapeutic legislative instrument ceases to have effect because it was disallowed, any instrument that had been amended or repealed by the disallowed instrument "revives" for WA application the day after the disallowance takes effect. This can reintroduce earlier regulatory settings with minimal notice , a compliance monitoring risk.

11. Cross-references in Commonwealth law are read as applying through ss 19 and 22 (s 25). When Commonwealth laws refer to other Commonwealth provisions, those references are to be read as references to the provision as applying because of ss 19 and 22. This can shift the effective reach of related provisions and should be checked where statutes cross‑refer.

12. AAT Part IVA references treated specially (s 22(5)). References to Part IVA of the AAT Act are to be read as they have effect at the Commonwealth level; the Act’s treatment here may alter expectations about the availability or scope of specific AAT review types.

13. The Act’s baseline date matters (s 5(1)). The Commonwealth therapeutic goods Act is imported as in force on 27 November 2023 together with certain amending Acts that meet WA tabling and disallowance rules (s 5(1)). Practitioners must know which version of the Commonwealth corpus is being applied.

14. Local regulation-making power is broad but time-limited for transitional regulations (s 31). While local regulations can make substantive modifications and address transitional matters, transitional regulations are limited to two years after commencement (s 31(3)). Long-term divergence from Commonwealth provisions requires a careful regulatory path.

15. Watch the overlap between Commonwealth and State enforcement agencies. The Act confers functions and powers on Commonwealth authorities in WA (ss 16, 20, 23) but does not set out an encompassing prosecutorial allocation. That can produce operational complexity as Commonwealth and State agencies exercise overlapping or complementary roles.

These "gotchas" arise directly from the Act’s provisions and their structural consequences. Practitioners should map the applied Commonwealth provisions, the local regulations, the publication/tabling status of instruments, the baselined version of the Commonwealth Act, and the fee and enforcement mechanisms.

1. Map applicable Commonwealth provisions and instruments to WA status. Create a register that lists Commonwealth Therapeutic Goods Act provisions and therapeutic legislative instruments as at 27 November 2023 and then tracks subsequent amending Acts and instruments. For each amending Act or instrument, verify publication under s 12(2), tabling under s 13(2), and whether it has been disallowed under s 13(3) or s 7 for amending Acts. Remember that an instrument not published or not laid ceases to have effect in WA (s 13(3)(a)-(b)). For instruments made under or for the purposes of an amending Act, s 11 requires synchronisation between Commonwealth commencement and the State’s proclamation (s 11(2)).

2. Audit existing operations against applied law baseline and transitional carve-outs. Identify any "transitioned conduct" under s 30 , conduct that was lawful immediately before commencement but would otherwise contravene applied law , and determine whether the business is within the two‑year safe harbour. Use the two‑year period to remediate, relicense, relabel, or otherwise adjust operations so that post‑transition compliance is achieved before that period expires (s 30(2)).

3. Review licences, permits and registrations for references to therapeutic goods law. The Act amends the Medicines and Poisons Act 2014 and the Human Tissue and Transplant Act 1982 to reference "therapeutic goods law" (Part 8, ss 32-38). Ensure that licences, conditions, compliance obligations and reporting mechanisms are reassessed in light of those definitional changes. Check administrative instruments and practice directions for required adjustments.

4. Budget for fee payments to the Commonwealth. Section 24 permits the Commonwealth to retain fees payable in respect of functions or powers performed under the applied law. Where fees previously were paid to WA agencies or where sponsors/importers historically budgeted with state fee expectations, update financial models to reflect potential Commonwealth fee retention.

5. Prepare for Commonwealth enforcement and administrative review. Because Commonwealth authorities and officers have functions and powers under the applied law (s 16) and relevant Commonwealth administrative laws apply (s 22), prepare to engage with Commonwealth processes such as AAT review, FOI requests and Ombudsman enquiries. Identify points of contact at relevant Commonwealth agencies and ensure document and records management aligns with Commonwealth privacy and FOI expectations.

6. Monitor WA parliamentary processes for tabling and disallowance. The WA Parliament can prevent amending Acts and instruments from taking effect in WA via notice of disallowance and resolution processes (ss 6-8, 12-13). Legal monitoring should include parliamentary sitting calendars, notices of motion, committee referrals under Standing Orders (s 9) and prospectively disallowed instruments, because the operative status in WA can change quickly if an instrument is disallowed.

7. Track local regulations and State modifications. Because s 15 and s 26 permit local regulations to modify the applied therapeutic goods law, monitor the WA Government Gazette and WA legislation website for local regulations that alter obligations, carve out exceptions or change administrative or criminal law application under ss 19 and 22. Provide clients with alerts when relevant local regulations are made.

8. Harmonise compliance manuals with Commonwealth interpretation standards. With the WA Interpretation Act 1984 not applying to the applied therapeutic goods law (s 14(2)) and Commonwealth interpretation laws applying instead (s 14(3)), update compliance manuals, internal guidance and legal opinions to reflect Commonwealth interpretive norms, not WA interpretive customs.

9. Reassess contractual indemnities and supplier clauses. Where contracts reference compliance with WA legislation that formerly used different definitions of therapeutic goods, reword warranties and indemnities to reflect the applied therapeutic goods law or the newly defined "therapeutic goods law" in the Medicines and Poisons Act and Human Tissue and Transplant Act (Part 8). Clarify which party bears compliance and fee risks, especially where fees may now be payable to Commonwealth agencies (s 24).

10. Plan for enforcement scenarios and litigation risk. Because offences may be treated as Commonwealth offences for many purposes (s 19), and Commonwealth authorities may exercise functions in WA (s 20), ensure regulatory incident response plans include engagement with Commonwealth investigators and the Commonwealth administrative law processes that now apply. Seek early legal advice where a matter involves criminal or civil penalty exposure under the applied therapeutic goods law.

11. Verify instrument validity before relying on it in compliance or commercial decisions. The Act provides that therapeutic legislative instruments may cease to have effect if not published, not laid, or disallowed (s 13). Before acting on an instrument’s requirements (for example, labelling, scheduling, clinical trial authorisation), confirm the instrument’s publication date, tabling status and whether a disallowance resolution has been moved or passed in WA.

12. Use transitional regulation window strategically. If regulatory relief or phased compliance is necessary, consider engaging with the WA Government on local transitional regulations permitted under s 31. That power is limited to two years (s 31(3)); if transitional relief is required beyond that horizon, it must be secured through other legislative or regulatory routes.

13. Ensure data handling and privacy compliance conforms to the Privacy Act 1988 as applied. With the Commonwealth Privacy Act applied as a law of the State in relation to the applied therapeutic goods law (s 22(1)), review records, consent forms and data-sharing arrangements to meet Commonwealth privacy standards and FOI expectations.

14. Clarify enforcement jurisdiction with insurers and legal counsel. Because the Act produces hybrid federal‑state characteristics for offences and administrative reviews, clarify with insurers and counsel which jurisdictional rules, costs, and liabilities govern enforcement, appeals and review procedures, and whether State or Commonwealth remedies will be pursued in particular circumstances.

Following these steps will require coordination among legal, compliance, regulatory affairs, finance and operations teams. Practitioners should set up cross‑functional governance to monitor Commonwealth instrument-making, WA tabling/disallowance timelines, local regulation-making, fee allocations and the two‑year transitional window to avoid surprises and manage legal risk under the new applied therapeutic goods law framework.