Therapeutic Goods (Charges) Act 1989

The Act is short and conceptually focused. The principal concepts are:

• Incorporation: Section 3(1) makes the Therapeutic Goods Act 1989 part of the legal lens through which this Act must be read. That incorporation imports the TGA Act’s definitions, Parts and interpretive provisions as applicable to the charging rules in this Act. The Act explicitly notes that references to registration include provisional registration by operation of the incorporated TGA Act s 3(8) (see the note to s 3 and the note to s 4(1)).
• Trigger event: The operative trigger for a charge is the status of being "in force at any time during a financial year" (see s 4(1), (1A), (1AA), (1B), (2) and (2A)). The Act repeatedly frames charge liability around that temporal test rather than, for example, the date of first entry or days of operation.
• Scope of entries attracting charges:
  • Registrations and listings of therapeutic goods (s 4(1)).
  • Grouped therapeutic goods subject to a single registration or listing number (s 4(1A)).
  • Biologicals included under Part 3‑2A (s 4(1AA)).
  • Kinds of medical devices included under Chapter 4 (s 4(1B)).
  • Licences (s 4(2)).
  • Conformity assessment body determinations (s 4(2A)).
• Treatment of suspensions and corresponding State law measures: The Act contains express provisions treating suspensions under specific Parts of the TGA Act as treating the goods or determinations as included in the Register "for the purposes of this Act" (s 3(1A), (1B), (2), (3)). It also provides that where TGA Act machinery causes registration or listing by operation of corresponding State laws, this charging Act applies "as if" those items had been registered or listed under the Commonwealth Parts (s 4(3)-(6)).
• Regulatory delegation: The Act does not set specific dollar amounts. It delegates the power to prescribe amounts and to make differential rates to regulations made by the Governor‑General (s 5(1)-(2)). Section 4(7) clarifies that "amount" may be zero.
• Definitions anchor: Section 4(7) defines "Therapeutic Goods Act" for the Act’s purposes as the Therapeutic Goods Act 1989, making cross‑references explicit.

These concepts combine to produce a legal structure in which the presence of various TGA‑regulated statuses during a financial year creates statutory exposure to an annual regulatory charge whose level and differentiation are left to subordinate legislation (s 4; s 5).

The Act’s language identifies the persons and entities who will become charge‑liable by reference to the regulated legal status they hold, not by naming particular classes of commercial actors. Who pays therefore depends on who holds or is responsible for:

• registrations and listings of therapeutic goods that are in force at any time during a financial year (s 4(1));
• grouped therapeutic goods covered by a single registration or listing number (s 4(1A)); this will affect the holder of that single registration or listing;
• biologicals included in the Register under Part 3‑2A (s 4(1AA));
• kinds of medical devices included in the Register under Chapter 4 (s 4(1B));
• licences that are in force at any time during a financial year (s 4(2));
• conformity assessment body determinations that are in force at any time during a financial year (s 4(2A)).

Because the Act is read with the Therapeutic Goods Act 1989 (s 3(1)), the practical identity of the persons responsible for registrations, listings and licences follows the TGA Act’s allocation of sponsor, registrant, licensee and conformity assessment body roles. The Act makes clear that the charging liability extends to entries that are present by operation of TGA Act mechanisms linking Commonwealth and State systems: where section 6AAE of the Therapeutic Goods Act results in goods being included in particular parts of the Register, this Act treats those goods "as if" they had been registered or listed under the relevant Commonwealth Part for charging purposes (s 4(3)-(5)). Similarly, licences issued under TGA sections operating with corresponding State laws are treated as issued under the Commonwealth Part 3‑3 for charging purposes (s 4(6)).

Administrative actors are also implicated:

• the Governor‑General is empowered to make regulations prescribing amounts and differentiations (s 5(1)-(2)); and
• the Secretary of the Department (via the TGA Act machinery referenced at s 4(6)) is the issuing authority for licences which the charging regime treats as attracting annual charges.

The Act’s definition that "amount includes a nil amount" (s 4(7)) means that, administratively, the regulations may impose zero charges; when that happens an otherwise affected person would formally be within the statutory class but carry no payment obligation.

The Act does not itself specify invoicing, collection, remission or dispute procedures, so those who are charge‑liable must look to the regulations or administrative practice for operational details. The Act therefore affects both regulated entities (sponsors, registrants, licence holders, conformity assessment bodies) and the regulatory decision‑makers who set charge levels by regulation (Governor‑General acting on regulations) and issue licences (Secretary).

The Act places a single, clear statutory duty at its core and foresees delegated responsibility for amount setting:

• Duty to pay an annual charge where the specified statuses are in force at any time during a financial year: the primary duty is that "annual charges of such amounts as are prescribed are payable" in respect of specified categories , registrations/listings, grouped registrations/listings, biologicals, kinds of medical devices, licences and conformity assessment determinations , whenever those items are in force at any time during a financial year (s 4(1), (1A), (1AA), (1B), (2), (2A)). The Act frames these as payable charges; it does not itself provide a billing timetable.
• Duty‑scope depends on TGA Act constructs: because the Therapeutic Goods Act is incorporated (s 3(1)), the duty to pay is linked to the definitions and statuses in that Act. The note to s 4(1) explicitly reiterates that references to registration include provisional registration as applied through s 3(1) and the TGA Act s 3(8).
• Duty follows particular treatments of suspensions and corresponding State effects: the Act makes explicit that certain suspensions under the TGA Act are to be taken, for the purposes of this Act, as including the goods in the Register (s 3(1A), (1B), (2), (3)). Those statutory treatments potentially continue or create charging exposure during suspension periods, because the Act ties charge liability to inclusion in the Register or to being "in force" (s 4).
• Right to nil charge: s 4(7) confirms that "amount includes a nil amount", which gives effect to a potential regulatory right not to be charged if the regulations prescribe a zero fee.
• Regulation‑set determinations: the Governor‑General, by regulation, determines the amount of annual charges and any differentiation among classes of goods, manufacturing steps or kinds of conformity assessment determinations (s 5(1)-(2)). The Act therefore confers a delegated administrative power rather than prescribing rights of registrants to challenge or appeal specified amounts within the Act itself.
• No express statutory remission, proration or dispute process: the Act is silent on procedural protections concerning the charging obligation, such as proration, remission, deferment, dispute resolution, or notice periods. Those matters are neither provided for nor implied by the text of the charging provisions (s 4) and so are left outside the Act’s express rights architecture.
• Interactional rights anchored in TGA Act: because the Therapeutic Goods Act is incorporated, any procedural or substantive rights that the TGA Act itself provides (for example, in relation to registration processes, suspensions, or administrative decision‑making) remain relevant to persons affected by the charging Act; the charging Act does not displace those provisions but situates charge liability against them (s 3(1)).

In summary, the Act creates a statutory duty to pay annual charges for a set of regulatory statuses whenever those statuses are in force during a financial year, delegates the determination of amounts to regulation, and leaves operational and dispute mechanisms to be found elsewhere.

The Act’s text contains no provisions that create offences, stipulate penalties, set out enforcement mechanisms, or specify debt‑recovery procedures. A plain reading of the statutory text shows:

• No criminal or civil penalty clauses: there are no sections that establish offences, attach fines, imprisonment, or civil sanctions for non‑payment or late payment within the Act itself.
• No collection or enforcement apparatus specified: the Act does not prescribe how the Commonwealth will invoice, demand, recover or enforce payment of the annual charges it creates. There are no provisions dealing with interest on overdue amounts, administrative garnishee powers, or suspension of regulatory status for non‑payment contained in this text.
• Reliance on subsidiary instruments or other statutory powers: because the Act delegates the setting of amounts to regulations (s 5), and because it incorporates the Therapeutic Goods Act (s 3(1)), the operational enforcement mechanisms for charging (billing, recovery, interest, powers to suspend or cancel registrations for non‑payment, appeal rights) would need to be located in the regulations made under this Act, in the TGA Act, or under other Commonwealth administrative or financial law. The Act itself supplies no such mechanisms.

Consequences for stakeholders are therefore procedural and legal uncertainty about how non‑payment will be treated under this Act unless and until regulations or other statutory instruments provide operational detail. Practitioners should note that the Act creates the substantive charging liability but contains no enforcement clauses; enforcement outcomes and penalties, if any, must be looked for outside the Act’s text.

This Act is constructed to operate in close textual and functional relationship with the Therapeutic Goods Act 1989. The primary interactions in the text are:

• Direct incorporation: Section 3(1) requires the Therapeutic Goods Act 1989 to be "incorporated, and is to be read as one, with this Act." That incorporation imports the TGA Act’s interpretive provisions and statutory architecture for determining what counts as registration, listing, provisional registration and related statuses. The note to s 3 points readers to the TGA Act s 3(8) to illustrate the import (that a reference to registration includes provisional registration).
• Suspension treatments: The Act modifies, for charging purposes, the operation of certain suspension provisions of the TGA Act by providing that where a suspension of registration or listing has effect under Part 3‑2, the goods are "taken to be included in the Register under that Part" for the purposes of this Act (s 3(1A)). Parallel treatments apply to biologicals suspended under Part 3‑2A (s 3(1B)), to kinds of medical devices suspended under Chapter 4 (s 3(2)), and to suspended conformity assessment body determinations under regulations made for purposes of Part 4‑4A (s 3(3)). These provisions create a statutory interface by which TGA Act suspension phenomena are given a specific charging treatment.
• Corresponding State law linkages: The Act recognises the TGA Act’s cross‑jurisdictional mechanisms. If section 6AAE of the Therapeutic Goods Act has the effect of inclusion in a particular part of the Register, this charging Act treats the goods "as if" they had been registered under the Commonwealth Part for charging purposes (s 4(3)-(5)). Similarly, where the Secretary issues a licence under TGA Act provisions that correspond to Part 3‑3 because of sections 6AAA-6AAC, this Act treats those licences as if issued under Part 3‑3 (s 4(6)). Those clauses ensure that the charging regime aligns with the TGA Act’s mechanisms for recognising State or corresponding law effects.
• Delegation to regulations consistent with Act: Section 5 delegates to the Governor‑General power to make regulations "not inconsistent with this Act" prescribing charge amounts and differentiations (s 5(1)). The regulations made under that power must operate within the Act’s scope , they cannot alter the core triggers set out in s 4 , but they can prescribe amounts, distinctions between classes, manufacturing steps for licensing charges, and kinds of conformity assessment determinations (s 5(2)).
• Definitions linkage: s 4(7) expressly defines "Therapeutic Goods Act" for the charging Act’s purposes as the Therapeutic Goods Act 1989, making theAct’s cross‑referencing explicit.

What this text does not do is to set out interactions with other Commonwealth financial or debt recovery laws, or to identify relevant administrative law remedies. Those interactions are not articulated in the charging Act itself and therefore must be sought in the regulations or in other statutes and administrative instruments that operate alongside the TGA Act and the Commonwealth’s financial management framework. In short, the charging Act relies on and is to be read with the TGA Act for definitional and status questions and leaves operational and enforcement interactions to subordinate instruments and other laws.

The copy of the Act supplied contains no amendment history notes, schedules or dates of subsequent amendments beyond the original commencement date stated in the text. From the Act text itself:

• The Act’s commencement provision states that "This Act commences on 1 July 1990" (s 2). That is the only temporal or historic datum supplied in the statutory text provided.
• The text as presented includes several subsections and paragraphs labelled with alpha‑numerals (for example s 3(1A), s 3(1B), s 4(1AA), s 4(1B), s 4(2A), s 4(3A), s 4(4A)), but the copy supplied does not annotate when those subsections were inserted or amended.
• There are no schedules attached to the supplied text listing amending Acts, nor are there notes indicating repeal or replacement of any provisions.

Given the absence of amendment metadata in the provided text, one cannot state from this source when particular subsections were added or modified. The Act as supplied should be treated as the operative text for the purposes of analysing content, but any practitioner needing the legislative history (dates of insertion, amending instruments, previous versions) will need to consult an official consolidating source or legislative history repository beyond the text supplied here. The Act itself establishes its short title (s 1) and commencement date (s 2), but it contains no running commentary or annotation of later amendments in the supplied material.

The supplied Act contains no references to judicial decisions, reviews, or litigation history. There are no cases named in the text, no references to judicial interpretation, and no citation of authority beyond the Therapeutic Goods Act 1989 which it incorporates.

Consequently, from the presented source alone:

• No litigated interpretations of this Act are recorded in the text; the Act does not cite any case law.
• There are no statutory notes indicating how courts have interpreted particular phrases such as "in force at any time during a financial year" or how tribunals have applied the charging provisions.
• Any related litigation that might bear on the construction, enforcement, or scope of this Act must be located outside the supplied text.

For practitioners seeking authoritative precedents about how courts treat the Act’s key phrases or the charging regime’s operation, an external case law search in the relevant databases would be necessary. The Act itself provides the statutory language but no reported adjudications.

Several concrete implementation, compliance and risk points flow from the Act’s wording and should be examined closely by practitioners and compliance officers:

• Temporal trigger creates potential full‑year exposure for part‑year statuses. The operative test is whether a registration, listing, licence or determination is "in force at any time during a financial year" (e.g. s 4(1), (2)). The Act contains no express provision for proration or part‑year reduction. Unless the regulations prescribe a proration mechanism or a nil amount for such circumstances, the statutory language can lead to liability for the full annual charge even where the status existed only for a short period within the financial year. The Act itself does not provide for refunds or crediting on cessation.
• Suspensions may not remove charge exposure. The Act expressly treats certain suspensions as inclusion in the Register for the charging Act’s purposes (s 3(1A), (1B), (2), (3)). That statutory treatment can result in charge exposure during a suspension period if the status is taken to be "included in the Register" under the relevant Part; the Act does not say that suspension negates charge liability.
• Grouped registrations create aggregated exposure. For "grouped therapeutic goods" covered by a single registration or listing number, s 4(1A) makes a single annual charge payable "in respect of all of the registrations or listings concerned". Practically, a single registration number that covers multiple goods can concentrate liability on the licence holder or sponsor responsible for that registration number. The Act does not specify how liability is to be allocated among commercial parties sharing interests in the grouped registration.
• Delegated discretion in regulation can create differential pricing. Section 5(2) authorises regulations to prescribe different charges for different classes of goods, different steps in manufacture (for licensing charges), and different kinds of conformity assessment determinations. That broad regulatory discretion can produce materially different cost profiles across products or businesses, depending on how regulations exercise it.
• Nil amount is possible but not automatic. Section 4(7) confirms that "amount includes a nil amount", allowing the regulations to set zero charges. However, the default statutory architecture leaves amounts to the regulations; nil charges require affirmative regulatory prescriptions.
• Corresponding State law effects can draw non‑Commonwealth statuses into Commonwealth charging. If the TGA Act’s section 6AAE produces an effect under corresponding State law, this Act treats those goods as if registered or listed under the relevant Commonwealth Part for charging purposes (s 4(3)-(5)). That mechanism can pull State‑related recognition into Commonwealth charge liability even where the primary regulatory entry happened through a State mechanism.
• Absence of enforcement and procedural details in the Act leaves operational uncertainty. The Act does not specify billing cycles, due dates, penalties for late payment, or appeal routes for disputing amounts. Those practical matters must be found in the regulations or in separate administrative frameworks; until they are located the charging consequences and remedies remain uncertain from the Act alone.
• Broadly framed terms may require cross‑Act readings. Because the Act imports the TGA Act by incorporation, questions about who is the legal person liable (sponsor, registrant, manufacturer) will require reference to the TGA Act’s definitions and allocation of roles (s 3(1); s 4(7)). Practically, compliance requires reading both Acts together.

These are not normative judgments but concrete operational risks and compliance levers that derive from the way the Act is drafted. Each of these "gotchas" is a direct reading of the statutory text and the delegations it creates.

Compliance under this Act requires attention to statutory triggers, monitoring of register status, and an understanding of how regulations have set amounts and differentiated charges. The following steps follow from the statutory text:

• Identify whether any relevant status was "in force at any time during a financial year". Under s 4(1), (1A), (1AA), (1B), (2) and (2A), charges become payable if a registration, listing, grouped registration/listing, inclusion of a biological, inclusion of kinds of medical devices, licence, or conformity assessment body determination was in force during the financial year. Compliance first requires determining the periods during which those statuses were in force.
• Monitor suspensions and how they are treated. Section 3(1A), (1B), (2) and (3) treat certain suspensions, for the purposes of this Act, as inclusion in the Register. Organisations must therefore track not only active approvals but also suspensions that the TGA Act treats as continuing inclusion for charging purposes.
• For grouped therapeutic goods, determine the registration/listing number coverage. If goods are covered by a single registration or listing number, s 4(1A) makes an annual charge payable "in respect of all of the registrations or listings concerned". Assign internal responsibility for that registration number and ensure the invoicing and budgetary processes reflect that single, potentially aggregated exposure.
• Confirm whether your product falls under biological inclusion or medical device kinds. The Act specifically triggers charges for biological inclusion under Part 3‑2A (s 4(1AA)) and for kinds of medical devices included under Chapter 4 (s 4(1B)). That classification will determine whether the relevant annual charge applies.
• Account for licences and conformity assessment determinations. If your operations require a licence or a conformity assessment body determination, s 4(2) and s 4(2A) make those statuses subject to annual charges. Ensure licensing renewals and determinations are part of financial forecasting.
• Consult the regulations for amounts and differentiation. The Act delegates specification of amounts to regulations (s 5(1)). Regulations may prescribe differential charges by class of goods, by manufacturing steps (for annual licensing charges), or by kinds of conformity assessment determinations (s 5(2)). Compliance requires obtaining and applying the current regulations to compute payable sums.
• Note that "amount includes a nil amount". Under s 4(7), regulations may set a nil amount. Confirm whether a zero charge has been prescribed for any relevant category.
• Prepare for the absence of procedural detail in the Act. Because the Act does not itself lay out invoicing, proration, remission, appeal, or enforcement procedures, compliance should include checking subordinate instruments (the regulations) and administrative guidance from the TGA or relevant Department to understand timing of notices, payment methods, and dispute processes.
• Coordinate between Commonwealth and State regulatory statuses. If registrations or licences arise through corresponding State law mechanisms (see s 4(3)-(6)), identify which entities will receive the charge and ensure that inter‑jurisdictional recognition does not produce unforeseen duplicated obligations.
• Recordkeeping and audit readiness. Given that liability is triggered by on‑register status "at any time" within a financial year, maintain contemporaneous records of registration/listing dates, suspension periods, licence terms, and conformity assessment determinations to support any questions or challenges about charge liability.
• Budget for regulatory discretion. Because regulations may introduce different charge levels across classes and manufacturing steps (s 5(2)), include scenario budgeting for possible regulatory differentials and for the possibility that charges may be prescribed or adjusted by regulation.

These compliance steps follow directly from the Act’s structure: it creates the liability by reference to the in‑force status during a financial year, and it leaves amounts and differentials to be prescribed by regulation. Practical compliance therefore depends on careful tracking of register and licence status, consultation of the regulations prescribing amounts, and appropriate internal recordkeeping.