Therapeutic Goods (Listing) Notice 2008 (No. 6)

The Notice rests on a small set of defined mechanisms and textual phrases. Lay out below are those concepts as they appear in the instrument and their operational role as instructions.

• Delegated power under subsection 9A(5) of the Act: The Notice is issued by a delegate of the Minister, named in the instrument as Rohan Hammett, exercising a specific statutory power to "require" inclusion of goods in the ARTG for listed goods. The presence of the subsection number indicates the legal source of the delegate's authority within the Therapeutic Goods Act 1989.

• Requirement to include in the ARTG for listed goods: The core directive is inclusion of particular preparations "in the part of the Australian Register of Therapeutic Goods ('the ARTG') for listed goods." The ARTG is the statutory register for therapeutic goods; this Notice compels that given items be listed within the ARTG's listed-goods section rather than being excluded or left unlisted.

• Preparations described by reference to the Regulations: The Notice identifies the covered products by reference to "Item 3 of Part 1 of Schedule 4 of the Therapeutic Goods Regulations 1990." It therefore anchors product scope to an existing schedule and item in the Regulations; the Notice does not elaborate the content of that schedule item, but applies to preparations described "for the purposes of Item 3 of Part 1 of Schedule 4" and limited to "oral use."

• Therapeutically active ingredient qualifier: Inclusion is limited to preparations that "contain [the named substance] as a therapeutically active ingredient." The Notice therefore links the requirement to the functional formulation of the product, not merely to presence of the chemical in any amount or context. The phrase "therapeutically active ingredient" is used as the qualifier for both dimethyl sulfone and vegetable oil phytosterol esters.

• Labelling conditions for vegetable oil phytosterol esters: The Notice sets out mandatory labelling content applicable only to the vegetable oil phytosterol ester class. It requires product labels to include advisory statements "to the effect of the following" and then provides two statements. The notice thereby imposes content obligations for consumer information on that subset of products.

• Temporal operation: The Notice begins "from the day after it is registered on the Federal Register of Legislative Instruments." It also expressly contemplates termination under subsection 9A(6) of the Act: it "ceases to have effect on the day that amendments to the Regulations come into effect to require inclusion of the therapeutic goods listed in this Notice in the part of the ARTG for listed goods." Thus the instrument is framed as an interim measure pending regulatory amendment.

• Identification of the issuer and date: The Notice is signed by Dr Rohan Hammett, described as "National Manager, Therapeutic Goods Administration, delegate of the Minister for Health and Ageing," and dated 27 November 2008. The instrument embeds both the officeholder and a date-stamp.

These concepts together define the instrument's legal mechanics: a narrow, temporary requirement that named oral preparations containing certain therapeutically active ingredients be listed in the ARTG, with a label-information obligation for one class, implemented by an authorised delegate until the Regulations themselves are amended.

The Notice names particular products and imposes a duty to include those products in the ARTG for listed goods; that requirement touches several actor categories. All statements below refer to the Notice as the source of direction.

• Sponsors and applicants who list goods in the ARTG: The duty "require[s] the following therapeutic goods to be included in the part of the ARTG for listed goods" means the population of persons or entities responsible for submitting listings to the ARTG are the immediate operational addressees. Those parties will need to ensure the specified preparations are listed in the ARTG in accordance with the Notice.

• Manufacturers, packers and labellers of the specified preparations: For products that contain vegetable oil phytosterol esters as a therapeutically active ingredient, the Notice requires that the "product label must include advisory statements" of the specified content. That obliges organisations responsible for product packaging and labelling to change label content to include the two advisory statements (or statements "to the effect of" those statements).

• Retailers and distributors: Once the products are listed and labelled in the manner the Notice prescribes, downstream sellers will handle goods that carry the required advisory statements. While the Notice does not directly address retailers, their operations will be affected insofar as they must not supply products that are non-compliant with the ARTG listing and labelling requirements under this instrument.

• Consumers, with specific subgroup identified: The labelling requirement for vegetable oil phytosterol esters includes the advisory "Not suitable for pregnant or lactating women." That explicitly identifies pregnant or lactating women as the subgroup of consumers for whom the product is labelled as unsuitable. In addition, the advisory "There is no benefit from taking more than 3g/day of phytosterols from all sources" addresses consumers who may consume multiple sources of phytosterols, signalling an information duty directed at end-users to limit aggregate daily intake.

• Regulatory officeholders and decision-makers: The Notice is an instrument issued by a delegate under s9A(5) of the Act; it therefore affects the administrative responsibilities of the Therapeutic Goods Administration and the delegate named (Dr Rohan Hammett). The instrument also anticipates administrative action to amend the Regulations later; the Act and Regulations are named as the governing instruments.

• The Minister for Health and Ageing as principal: The Notice is issued by a delegate of the Minister for Health and Ageing. While the instrument itself does not specify steps for the Minister, the existence of delegation affects who is recorded as responsible for the direction.

The Notice restricts its scope to preparations "for oral use" and to preparations that contain the specified substances "as a therapeutically active ingredient." This scope means products that are topical, injectable, or otherwise non-oral, or those that contain the named substances in non-therapeutic roles, are not covered by the text of this instrument as written.

The Notice imposes a small set of discrete duties, and it records certain administrative rights by reference. The instrument itself does not create a broad rights catalogue; it focuses on mandated actions and an administrative timeline.

Primary duties imposed:

• Inclusion duty: The Notice "require[s] the following therapeutic goods to be included in the part of the ARTG for listed goods." That is the central duty. The entities responsible for ARTG entries must effect inclusion of the two classes of preparations described. The Notice frames this as a mandatory inclusion rather than a permissive or discretionary listing.

• Labelling duty for vegetable oil phytosterol esters: The Notice states, "The product label must include advisory statements to the effect of the following:" and supplies two specific advisory statements. This is a mandatory labelling requirement for the products in the vegetable oil phytosterol esters class. The labelling content requirement is phrased as "to the effect of," which imports some allowance for equivalent wording, but the content required is expressly prescribed.

Temporal obligations and transitions:

• Commencement obligation: The Notice "commences from the day after it is registered on the Federal Register of Legislative Instruments." That creates an operative start point for the duties. Parties must be ready to comply from that day forward.

• Cessation event: The Notice states it "ceases to have effect on the day that amendments to the Regulations come into effect to require inclusion of the therapeutic goods listed in this Notice in the part of the ARTG for listed goods." Thus the Notice creates a temporary duty that will lapse automatically upon a specified change to the Regulations. Parties should therefore intend the Notice as an interim mechanism until the Regulations are amended.

Rights and administrative authority:

• Delegated authority to require listing: The Notice records that it is made by "ROHAN HAMMETT, National Manager, Therapeutic Goods Administration, delegate of the Minister for Health and Ageing for the purposes of subsection 9A(5) of the Therapeutic Goods Act 1989 ... and acting under that provision." The instrument thereby evidences the delegate's right, under s9A(5) as cited, to require inclusion of specified goods in the ARTG. The Notice itself does not catalogue appeal rights, objection procedures, or other statutory rights of affected parties; it simply exercises the delegated power.

Matters not specified in the Notice:

• Enforcement consequences and sanctions are not articulated in the instrument. The Notice requires inclusion and prescribes labelling, but it does not state the consequences of failing to comply, nor does it establish a procedure for exemptions, variances, or reviews within the text provided.

In sum, the Notice sets binding duties to list the named oral preparations in the ARTG and, for one class, to include specified advisory statements on the product label, with the duties activated by the registration date and terminated by a specified regulatory amendment event.

The text of the Notice is concise and does not provide express penalties, infringement notices, or enforcement procedures. The instrument sets mandatory actions,requirement of inclusion in the ARTG and mandatory advisory labelling for vegetable oil phytosterol esters,but it does not itself specify the direct legal consequences of non-compliance, nor does it spell out the enforcement body beyond referencing the delegate who issued the Notice.

What the Notice states:

• It "require[s]" inclusion and stipulates labelling obligations. The Notice uses mandatory language ("must include") for the advisory statements tied to vegetable oil phytosterol esters.

What the Notice does not state:

• There is no provision within the instrument text that sets out offences, civil penalties, administrative sanctions, or compliance notices for failure to include goods in the ARTG or failure to include the specified labelling. The Notice does not set out a compliance timetable beyond the commencement and cessation triggers described.

Operational inference from the instrument itself:

• Because the Notice is an exercise of the delegate's power under subsection 9A(5) of the Act, any determination of sanctions, prosecutions, or regulatory enforcement would, if necessary, proceed under the broader statutory and regulatory framework referenced (the Act and the Regulations). The Notice itself does not purport to replace or restate any such enforcement provisions; it simply imposes the requirement. The instrument also contemplates a regulatory amendment that would make the inclusion requirement permanent by updating the Regulations, at which point enforcement and penalty rules embedded in the Act or Regulations for non-compliance with the Regulations would presumptively govern, but the Notice does not itself set those rules out.

Practical consequence for affected parties:

• Affected sponsors, manufacturers and labellers will need to act to list the relevant goods and include the required advisory labelling for vegetable oil phytosterol esters from the commencement date. Because the Notice lacks an express sanctions clause, parties should consult the broader statutory regime (the Act and the Regulations) to determine enforcement measures and penalties that might attach to non-compliance; however, that determination lies outside the language of this instrument.

In short, the Notice imposes mandatory duties but does not contain within its text an express enforcement mechanism or enumerated penalties; it operates as a delegated administrative requirement whose enforcement implications derive from the wider legal framework rather than from clauses in the instrument itself.

The Notice explicitly situates itself in relation to two statutory instruments and their relevant provisions. The instrument is not a freestanding law; it is an administrative notice that operates within the framework of the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990 and the ARTG regime established by those instruments.

Direct statutory references in the Notice:

• Therapeutic Goods Act 1989: The Notice is made "for the purposes of subsection 9A(5) of the Therapeutic Goods Act 1989" and expressly invokes subsection 9A(6) for its termination rule. The text therefore anchors both the delegation of authority to the signatory and the temporal termination to two subsections of the Act.

• Therapeutic Goods Regulations 1990: The products covered are described by reference to "Item 3 of Part 1 of Schedule 4 of the Therapeutic Goods Regulations 1990." The Notice does not restate the content of that Schedule item; it uses the Schedule item as the definitional reference for the products to be included.

Interaction with ARTG listing regime:

• The Notice requires inclusion "in the part of the Australian Register of Therapeutic Goods ('the ARTG') for listed goods." That places the listed preparations into the ARTG's listed-goods category; the Notice thereby changes the set of products required to be recorded in that part of the register.

Temporal interaction with Regulations:

• The Notice is expressly temporary and self-terminating: it "ceases to have effect on the day that amendments to the Regulations come into effect to require inclusion of the therapeutic goods listed in this Notice in the part of the ARTG for listed goods." This clause indicates that the Notice is intended as an interim administrative measure pending a formal amendment of the Regulations. Once the Regulations themselves are amended to require the inclusion, the need for the delegate's Notice ends automatically.

Scope-limiting references:

• By tying coverage to "Item 3 of Part 1 of Schedule 4," the instrument interacts with that Schedule’s definitions and scope. The Notice does not alter or replace Schedule 4; it sets the obligation only for goods that fall within that regulatory description and are "for oral use."

Label information and broader consumer-safety frameworks:

• The labelling obligations in the Notice apply only to the vegetable oil phytosterol esters class and require advisory statements on limits and unsuitability for a subgroup. The Notice does not reference other labelling laws or standards; however, its imposition of labelling text interacts practically with other labelling obligations under the broader legal framework (that is, if there are other statutory labelling rules, those would coexist with the Notice’s requirement). The instrument itself does not identify any conflict-resolution rules or indicate precedence.

Delegation chain:

• The Notice records that a delegate of the Minister, in the capacity of National Manager of the Therapeutic Goods Administration, issued the instrument under s9A(5). That reflects a delegated-administration relationship within the Act’s framework. The Notice does not identify any exercises of concurrent powers, nor does it attempt to expand a delegate’s authority beyond the specific subsections cited.

In sum, the Notice functions as a targeted, temporary administrative overlay on the existing Act/Regulations/ARTG architecture: it uses a delegation under the Act to require the inclusion of certain Schedule-4, Item-3 oral preparations in the ARTG and to require specific labelling for vegetable oil phytosterol esters, while explicitly deferring to an eventual amendment of the Regulations to make the inclusion requirement statutory and thereby terminate the Notice.

The instrument itself contains a limited internal record of its lifecycle and does not document prior amendments to the Notice. The Notice provides both its commencement trigger and its termination trigger, and it bears an issuance date. Specific elements are as follows.

Issuance and date:

• The Notice is dated and signed: "Dated this 27th day of November 2008" and "Signed by Dr Rohan Hammett, Delegate of the Minister for Health and Ageing." That is the instrument's date of signature and its formal authorisation date as presented in the text.

Commencement:

• The instrument "commences from the day after it is registered on the Federal Register of Legislative Instruments." The Notice does not specify the registration date itself in the body beyond the instruction that commencement follows registration; the date of signature (27 November 2008) is present but the text ties operation to registration on the Federal Register of Legislative Instruments, which is the operative start point.

Termination and supersession:

• The instrument expressly contemplates termination: "Pursuant to subsection 9A(6) of the Act this Notice ceases to have effect on the day that amendments to the Regulations come into effect to require inclusion of the therapeutic goods listed in this Notice in the part of the ARTG for listed goods." Thus the Notice is explicitly temporary and designed to remain in force only until the Regulations themselves are changed to enshrine the inclusion requirement. The instrument thereby sets its own amendment/expiry trigger in relation to future amendments of the Regulations.

Absence of further amendment records in text:

• The Notice does not record any subsequent amendments to itself. It neither lists prior instruments that it replaces nor contains a schedule of changes over time. The instrument as provided is a single-directional measure with a defined expiry condition rather than a gradually amended regulatory schedule.

Implication for users monitoring amendment history:

• Because the Notice is tied to the registration event to commence and to a future amendment of the Regulations to cease, affected parties will need to monitor (a) the Federal Register of Legislative Instruments for the Notice's registration to determine its exact commencement date, and (b) any subsequent amendment to the Therapeutic Goods Regulations 1990 that would render the Notice redundant. Those monitoring steps are implied by the Notice’s timing clauses but are not specified in detail in the instrument.

In short, the Notice contains no internal amendment history beyond its signature date and the two temporal clauses that govern when it begins and when it ends; it is expressly temporary and is intended to be replaced by a Regulations amendment at a later date.

The Notice itself contains no references to litigation, court decisions, or legal proceedings. The instrument is an administrative notice and does not cite cases, past disputes, or judicial determinations. Concretely:

• There are no judicial citations within the text of the Notice.
• The Notice does not purport to vindicate, respond to, or follow from any court ruling; it is an exercise of delegated power under subsection 9A(5) of the Act.

What the instrument does indicate:

• The Notice is a stand-alone administrative instrument issued by a delegate of the Minister and dated 27 November 2008. It does not document, reference, or hint at litigation as part of its rationale or legal history.

Consequences for practitioners and researchers:

• There is nothing inside the Notice to report as litigation history; those seeking judicial consideration of this instrument would need to consult external records (court files, tribunal determinations) outside the text of this instrument. The absence of litigation references in the Notice does not imply there has been none, only that the instrument itself does not record any.

In sum, the instrument contains no litigation history or related judicial references within its text.

The Notice is succinct but contains several drafting features and phrase choices that create practical compliance and interpretation issues for those affected. Below are specific points, each grounded in the Notice's wording.

1. Scope limited to "for the purposes of Item 3 of Part 1 of Schedule 4": The products required to be included are defined by reference to a particular item in Schedule 4 of the Regulations. The Notice does not define that item; therefore parties must confirm whether their product falls within the Schedule-4, Item-3 description. A product that contains dimethyl sulfone or vegetable oil phytosterol esters but does not meet the Schedule-4 Item-3 description is not captured by the Notice as worded.

2. Requirement restricted to "oral use": Both product classes are limited to "for oral use." Preparations containing the named substances for non-oral routes (topical, injectable, inhaled, etc.) are not captured by the Notice. Sponsors must confirm the route of administration to determine applicability.

3. The qualifier "as a therapeutically active ingredient": The Notice applies only when the named substance is present "as a therapeutically active ingredient." If an applicant's formulation lists the substance in a non-therapeutic role (for example, a stabiliser, excipient, or incidental contaminant), the Notice as worded does not mandate listing. Determination of "therapeutically active ingredient" will therefore be a threshold issue.

4. Labelling requirement phrased "to the effect of the following": For vegetable oil phytosterol esters the label "must include advisory statements to the effect of the following" followed by two statements. The phrasing permits some paraphrase so long as the content is consistent with the specified statements, but it leaves room for interpretation as to how literal or paraphrased the statements must be. Practitioners should note the exact wording provided in the instrument but also that the instrument itself uses the permissive "to the effect of" phrase.

5. Exact wording of advisories matters materially: The two advisories are:

   • "There is no benefit from taking more than 3g/day of phytosterols from all sources"; and
   • "Not suitable for pregnant or lactating women". The inclusion of "from all sources" in the first advisory imposes an aggregate-consumption framing. Manufacturers and label-preparers must consider other sources of phytosterols that a consumer might use, and the phrase may imply a need to instruct consumers about cumulative daily intake across products.

6. Different treatment of the two listed ingredients: Dimethyl sulfone and vegetable oil phytosterol esters are both required to be included in the ARTG when they are therapeutically active ingredients in oral preparations, but only the phytosterol esters class has explicit labelling conditions in the Notice. Sponsors of dimethyl sulfone preparations will thus face the inclusion duty but not the specific label-advisory duty set out here.

7. Temporary nature tied to Regulations amendment: The Notice "ceases to have effect on the day that amendments to the Regulations come into effect" to require inclusion. That makes the Notice an interim instrument pending a regulatory amendment. Parties must therefore monitor both the Federal Register for the Notice's registration date (to know its commencement) and the Regulations for amendments that will supersede the Notice.

8. Commencement date depends on registration: The Notice does not commence on signature; it commences "from the day after it is registered on the Federal Register of Legislative Instruments." The signature date (27 November 2008) is not necessarily the commencement date. Stakeholders must verify the registration date to determine when obligations become enforceable.

9. No penalties or enforcement details in the Notice: The instrument imposes duties but does not state what happens if a product is not included or labelled as required. Parties should not assume the Notice contains its own sanctioning mechanism; that question will be governed by the broader Act/Regulations or other administrative practice outside the Notice text.

10. Delegated signatory: The Notice is made by a delegate (the National Manager of the TGA) and not directly by the Minister. The instrument identifies the delegate and the statutory subsection authorising delegation (9A(5)). That matters for administrative responsibility and record-keeping: the delegate's signature formalises the Notice's authority under the cited subsection.

Those are the principal operational and interpretive "gotchas" directly derivable from the Notice's text.

Compliance with this Notice requires a limited set of concrete actions tied to the instrument's duties, timing clauses and labelling requirements. The steps below follow directly from the text of the Notice and highlight what actors need to do, and what they should verify, to meet its obligations.

1. Confirm product scope against the Notice wording:

   • Verify that the product is a "preparation for the purposes of Item 3 of Part 1 of Schedule 4 of the Therapeutic Goods Regulations 1990." The Notice defines the applicable products by reference to that specific Schedule item and to "oral use." Confirm the product's classification under that Schedule item and that the route of administration is oral.
   • Confirm that the named substance (dimethyl sulfone or vegetable oil phytosterol esters) is present "as a therapeutically active ingredient." If the substance is present only as an excipient or otherwise non-therapeutic component, the Notice as written does not apply.

2. Prepare ARTG listing for listed goods:

   • For products that meet the scope, ensure that the goods are included "in the part of the ARTG for listed goods" as required by the Notice. The Notice requires inclusion; parties responsible for ARTG entries should prepare and submit whatever listing documentation and evidence the ARTG process requires (the Notice itself imposes the inclusion requirement and ties the timing to the registration date).

3. Implement labelling changes where applicable:

   • If the product contains vegetable oil phytosterol esters as a therapeutically active ingredient and is for oral use, ensure that the product label includes advisory statements "to the effect of the following" and include wording consistent with:
     • "There is no benefit from taking more than 3g/day of phytosterols from all sources"; and
     • "Not suitable for pregnant or lactating women".
   • Decide on the extent to which the label will adopt the wording verbatim or will paraphrase "to the effect of" the statements, recognising the Notice allows statements to be "to the effect of" the provided text. Keep a record of the final label text and the reasoning for its formulation as evidence of compliance.

4. Time compliance to the Notice's commencement:

   • The Notice "commences from the day after it is registered on the Federal Register of Legislative Instruments." Determine the registration date and ensure that all listing submissions and labelling changes are effective on or before the commencement date as required.

5. Monitor Regulations for the cessation event:

   • The Notice "ceases to have effect on the day that amendments to the Regulations come into effect to require inclusion of the therapeutic goods listed in this Notice in the part of the ARTG for listed goods." Monitor amendments to the Therapeutic Goods Regulations 1990. Once the Regulations themselves require inclusion, the Notice will terminate; regulatory amendments may alter the formal compliance pathway or the permanence of the listing obligation.

6. Document compliance steps:

   • Retain copies of ARTG listing submissions, confirmation of listing, final label artwork and proof of manufacture packaging that shows the advisory statements. Maintain dated records showing when label changes were implemented relative to the Notice's commencement date and any subsequent Regulations amendments.

7. Be attentive to aggregate-intake language:

   • For the phytosterol advisory stating "There is no benefit from taking more than 3g/day of phytosterols from all sources," consider how that statement will be presented so consumers can understand the "from all sources" aspect. Label text should make clear that the limit applies to combined daily consumption from multiple products; production and marketing teams should ensure the label is not misleading in that regard.

8. Distinguish obligations for dimethyl sulfone:

   • Products containing dimethyl sulfone as a therapeutically active ingredient and for oral use are required to be included in the ARTG under this Notice, but no specific labelling statements are prescribed in this instrument. Ensure listings for such products proceed, but do not assume the phytosterol labelling obligations apply to dimethyl sulfone.

9. Preserve administrative communications:

   • Keep copies of the Notice, the registration certificate from the Federal Register of Legislative Instruments showing the registration date, and any correspondence with TGA or the Minister's delegate. These documents will assist in proving compliance timelines and decisions.

10. Verify the delegate and authority:

• The Notice is signed by Dr Rohan Hammett and references subsection 9A(5) as the enabling provision. Organisations should retain the signed Notice as evidence of the delegate's direction and the statutory authority invoked.

These steps flow directly from the instrument’s text and lay out the immediate, operational obligations: confirm product coverage under the Schedule item and oral-use requirement, list the products in the ARTG for listed goods from the commencement date, include the required advisory labelling for vegetable oil phytosterol esters, and document all actions. The Notice’s termination upon a Regulations amendment means affected parties must also monitor and adapt to the eventual transfer of the requirement into the Regulations themselves.