Therapeutic Goods (Medicines and Biologicals—Ingredients and Components Information) Specification 2020

The instrument rests on a small set of tightly defined concepts. Each concept is given a statutory definition within the instrument (s 4) or is adopted from the Act or the Regulations. The main concepts are:

• Relevant goods. A "relevant medicine" is a medicine included in the Register as a registered good or a listed good. A "relevant biological" is a biological included in the Register (s 4). The instrument applies only to goods that meet those definitions, so goods outside the Register fall outside the specification.

• Therapeutic goods information. The instrument ties into the Act by adopting the statutory phrase "therapeutic goods information" as defined by subsection 61(1) of the Act (s 4, note). The instrument does not redefine that phrase, instead it specifies particular "kinds" of therapeutic goods information for the purpose of subsection 61(5C) via subsection 61(5D) of the Act (s 3 and s 5).

• Active ingredient and active component. For medicines, the instrument uses the term "active ingredient", which is given the same meaning as in the Regulations (s 4). For biologicals, the instrument defines "active component" as a therapeutically active component in the final formulation that is responsible for the biological's physiological action (s 4). The Schedule requires disclosure, for relevant goods, of the name and amount of each active ingredient/component (Schedule 1 Part 1 item 1; Part 2 item 1).

• Other ingredient and other component. The instrument distinguishes "other" ingredients/components from active ones, and explicitly excludes proprietary colours, flavours and fragrances from the "other" category (s 4). For relevant goods, the Schedule requires disclosure of the name of each other ingredient/other component, but does not require amounts for those "other" items (Schedule 1 Part 1 item 2; Part 2 item 2).

• Proprietary colour, flavour, fragrance. These are defined as formulations identified as proprietary ingredients in TGA Business Services for the purpose of providing colour, flavour or fragrance to a therapeutic good (s 4). Where such a proprietary ingredient is present, the Schedule specifies that the information released is limited to the single word "colour", "flavour" or "fragrance" respectively (Schedule 1 Part 1 items 3 to 5; Part 2 items 3 to 5). The instrument therefore operationalises a distinction between named ingredients/components and proprietary formulations that are registered in a particular way in the TGA Business Services portal.

• TGA Business Services as the register of proprietary status. The instrument expressly references TGA Business Services as the locus where a formulation is identified as a proprietary ingredient (s 4). This ties the legal effect of being "proprietary" to an administrative record, rather than to a substantive test of confidentiality or trade secret under the instrument itself.

• Link to the Act. The instrument is explicit that it serves the purpose of subsection 61(5C) via the specification power in subsection 61(5D) of the Act (s 3 and s 5). The instrument contains a note clarifying that kinds specified under subsection 61(5D) may be released by the Secretary under subsection 61(5C) (note following s 5).

Taken together, these concepts create a structured disclosure regime: active moieties are exposed by name and amount, non-active ingredients/components are exposed by name only, and proprietary formulation elements recorded in TGA Business Services are revealed only by a single generic word. The definitions centralise the TGA's administrative records as determinative of whether a formulation is "proprietary" in the sense used by the specification.

The instrument affects identifiable groups in the therapeutic goods regulatory ecosystem, by changing what kinds of ingredient and component information the Secretary may make public under the Act. The core affected parties are:

• Sponsors and manufacturers of medicines and biologicals that are included in the Register. A "relevant medicine" is a medicine included in the Register as a registered good or a listed good, and a "relevant biological" is a biological included in the Register (s 4). For those sponsors, the Schedule determines which ingredient/component information the Secretary can release under s 61(5C). Practically, sponsors are the actors who maintain the entries on the Register and in TGA Business Services, and so the instrument affects their record-keeping choices, particularly whether to have formulations identified as "proprietary" in TGA Business Services.

• The Therapeutic Goods Administration and the Secretary. The instrument directly influences administrative practice by specifying the categories of information that the Secretary may disclose under the Act. The Secretary retains the decision to release or withhold under subsection 61(5C) of the Act, but the instrument defines the specific kinds of information that are available for public release under that statutory pathway (s 3 and s 5). The TGA Business Services function is implicated as the administrative reference point for proprietary identification (s 4).

• Consumers, health professionals and intermediaries. The categories defined in the Schedule determine what information stateside users can expect to find in any public release by the Secretary. For example, active ingredients/components will be available by name and amount, while other ingredients/components will be available by name only, and proprietary colours, flavours and fragrances will be described only generically (Schedule 1).

• Competitors and researchers. The instrument has competitive and research implications because it prescribes which composition details may be disclosed publicly. Where a formulation element is recorded as a "proprietary" ingredient in TGA Business Services, the release will not reveal the specific identity of that formulation, only that a proprietary colour, flavour or fragrance is present (s 4 and Schedule 1 items 3 to 5). That mechanism determines the degree to which product composition is publicly available for market comparison, safety research, or labelling analysis.

• Regulators and auditors. Although the instrument itself does not create enforcement obligations, its definitions and linkage to the Register and TGA Business Services mean that auditors and inspectors will treat these administrative records as determinative for the purpose of the public release categories (s 4 and s 5).

Who is not affected by this instrument, on its own terms, is also important. The instrument is limited to medicines and biologicals included in the Register; therapeutic goods not included in the Register, or information outside the specified categories, are not addressed. The instrument does not itself require sponsors to submit particular data to the Register; it specifies what may be released under subsection 61(5C) if such data exists in the Register or in TGA Business Services. The instrument therefore chiefly affects those who already participate in the Register and TGA Business Services infrastructure.

The specification is an enabling and categorising instrument rather than a source of freestanding duties or criminal sanctions. Nonetheless, it creates discrete administrative effects that translate into duties and practical rights within the existing statutory framework.

Duties, as implied by the instrument and the way it is framed, include:

• Maintain accurate Register entries and TGA Business Services identifications. The instrument defines "proprietary colour", "proprietary flavour" and "proprietary fragrance" by reference to identification in TGA Business Services (s 4). If a sponsor wishes an ingredient to be treated as a proprietary formulation for the purpose of public release under subsection 61(5C), the instrument requires that the formulation be identified as a proprietary ingredient in TGA Business Services. The instrument does not set out the process for identification, but the legal effect of "proprietary" depends on that identification.

• Understand the content categories that may be released. For relevant medicines and biologicals, the Schedule specifies what kinds of information are within scope for release under s 61(5C): name and amount of active ingredients/components, name of other ingredients/components, and the single-word indication for proprietary colour/flavour/fragrance (Schedule 1 Part 1 and Part 2). Sponsors therefore have a practical duty to recognise that active ingredient/component names and amounts may be made publicly available via the Secretary under the Act.

• Ensure consistency between Register data and product labelling/regulatory submissions. Because the Schedule ties public-release content to the Register and to TGA Business Services identifiers, sponsors have a practical obligation to ensure that those records reflect the composition they are willing to have potentially released.

Rights established or clarified by the instrument include:

• Right to have certain proprietary formulations indicated generically. The instrument creates a legal mechanism by which the presence of a proprietary colour, flavour or fragrance, if identified in TGA Business Services, will be represented in any public release only by the words "colour", "flavour" or "fragrance" (Schedule 1 Part 1 items 3 to 5 and Part 2 items 3 to 5). That constitutes a right, in the sense that sponsors holding proprietary formulations that carry the relevant administrative designation will have a defined limitation on what is disclosed about those formulations under the subsection 61(5C) release pathway.

• Right to expect names and amounts of active moieties to be available for relevant goods. The Schedule makes clear that active ingredient/component names and amounts are the kinds of information the Secretary may disclose under s 61(5C). Sponsors therefore have a limited expectation that these items are the categories likely to be released; conversely, the public has a corresponding right to access those categories of information if the Secretary proceeds to release.

What the instrument does not do, and therefore does not impose, is to create new enforcement powers, civil causes of action, or criminal penalties. It also does not itself mandate submission of ingredient lists or quantities; those submission obligations, and penalties for false or misleading entries, if any, would reside in the Act, the Regulations, or other instruments outside this specification. The instrument is explicitly a specification for the purpose of s 61(5C) via s 61(5D) of the Act (s 3 and s 5), and its operative effect is therefore to delineate what "therapeutic goods information" may be released, not to create standalone duties or sanctions.

The instrument contains no penalty or enforcement provisions. It is a specification made under subsection 61(5D) of the Act that identifies kinds of information for potential public release under subsection 61(5C) (s 3 and s 5). There is no clause within the instrument that creates offences, civil remedies, or administrative sanctions.

Consequently, enforcement and penalties, if any, must be sought in the Act and the Regulations. The instrument refers to the Act for the meaning of "therapeutic goods information" (s 4), and it relies on the Act's release mechanism in subsection 61(5C) and the specification power in subsection 61(5D) (s 3 and s 5). Any coercive enforcement against incorrect Register entries or misuse of TGA Business Services will therefore have to be located in those primary statutes or in other subordinate instruments that expressly create offences or sanctions. The specification itself neither authorises enforcement actions nor prescribes compliance penalties.

Operationally, this means:

• The Secretary has discretion under the Act to release specified kinds of information, but the instrument does not authorise or constrain enforcement action against a sponsor for the content or omission of entries. Any consequences for inaccurate information on the Register will arise under other provisions of the Act or the Regulations, not under this specification.

• Administrative practice and compliance management by the TGA will determine how the identification of proprietary ingredients is treated in records and whether sponsors are required by other instruments to provide supporting documentation. The instrument does not set evidentiary standards or documentation requirements for establishing that a formulation is proprietary in TGA Business Services.

• The specification implicitly allocates risk over confidentiality and exposure. Sponsors whose entries are inaccurate or incomplete may face commercial or reputational costs when the Secretary exercises release powers under the Act. But the instrument itself does not create investigative, audit or sanctioning powers to rectify such inaccuracies; those would be found elsewhere in the statutory framework.

For those seeking to challenge a disclosure made by the Secretary under subsection 61(5C), the instrument does not create a separate statutory appeal pathway. Remedies or review of decisions to release information would depend on the Act, administrative law principles and any review mechanisms contained in the Act or other primary legislation. The instrument simply identifies the categories of information that the Secretary may release under s 61(5C); it does not set review or appeal rights.

The specification is deliberately narrow and rests explicitly on provisions of the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990. The instrument interacts with other laws principally by reference, not by creating standalone obligations.

Primary statutory linkages and interactions within the instrument are:

• Therapeutic Goods Act 1989. The instrument is made under subsection 61(5D) of the Act (s 3). It uses the Act's terms "Register", "included in the Register", "therapeutic goods", and "therapeutic goods information" by reference to the Act. The core operational interaction is that this instrument supplies the content categories that the Secretary may release under subsection 61(5C) of the Act (s 5 and the Note following s 5). Because the Act defines the overall release power and any limitations, the instrument functions as a subordinate specification within the Act's release framework.

• Therapeutic Goods Regulations 1990. The instrument adopts the Regulations' definition of "active ingredient", by stating that "active ingredient has the same meaning as in the Regulations" (s 4). That means that, for the purpose of determining what information is an "active ingredient" and therefore subject to the name and amount disclosure requirement, one must consult the Regulations.

• Administrative record-keeping and portals. The instrument makes TGA Business Services the determinative administrative record for whether an ingredient is a "proprietary colour", "proprietary flavour" or "proprietary fragrance" (s 4). That creates an interaction with any procedural or legal rules governing TGA Business Services, including user agreements, access controls, and any separate guidelines that govern how proprietary status is recorded in that portal. The instrument itself does not create those procedural rules.

• Register entries and regulatory submissions. The specification ties the public-release categories to goods "included in the Register" (s 4). The legal obligations to list goods, and any standards for information to be included on the Register, will be found in the Act and Regulations. This instrument therefore interacts with the broader regime governing Register entries, including any obligations on sponsors to provide compositional information.

• Other information-disclosure regimes. The instrument is silent on interaction with freedom of information, privacy, trade secret or consumer protection laws. It does not displace or reconceive those regimes. Any overlap, for example between a public disclosure under subsection 61(5C) and a right to confidentiality claimed under another statute or on commercial grounds, would have to be reconciled by reference to the Act and to other applicable laws. The instrument provides no mechanism for resolving conflicts between the Act's release power and other legal regimes.

• No substitution of labelling or advertising law. The instrument does not change labelling, advertising or product information obligations. It only specifies what the Secretary may release publicly under the Act's information-release provisions. Any separate obligations on labels, leaflets, or advertising remain governed by the Act, the Regulations, or other consumer protection legislation.

In effect, the specification operates as an administrative taxonomy, slotting itself under the Act's release power, drawing on the Regulations for technical definitions, and anchoring the term "proprietary" to the TGA Business Services portal. Users seeking to understand the full legal consequences of disclosure or non-disclosure must therefore consult the Act, the Regulations and any administrative policies or guidelines governing TGA Business Services and Register entries.

The instrument records a minimal amendment history within the text supplied. It identifies the original making and commencement details and contains a standard note about the table of commencement.

Key points about amendment history and provenance extracted from the instrument are:

• Date and maker. The instrument is dated 7 February 2020, and bears the signature and delegation of Jane Cook, First Assistant Secretary, Medicines Regulation Division, Health Products Regulation Group, Department of Health, acting as delegate of the Minister for Health. The instrument states that it is made under subsection 61(5D) of the Therapeutic Goods Act 1989 (s 3 and the heading material).

• Commencement. Section 2 contains a commencement table that states "the whole of this instrument" commences "the day after this instrument is registered" (s 2(1) and the table). There are the usual drafting notes that the table relates only to the provisions as originally made and will not be amended to deal with later amendments of the instrument (s 2 note).

• No recorded subsequent amendments in the instrument text. The body of the instrument itself contains a specific note that commencement information as given relates to the instrument "as originally made" and will not be amended in the instrument to reflect later amendments. The text supplied contains no later amendment entries, no amending instruments, and no repeal provision. Therefore, on the face of the instrument, its operative content is the original specification made on 7 February 2020.

• No transitional or saving provisions included. The instrument contains no specific transitional arrangements, grandfathering, or saving clauses for existing Register entries or existing public disclosures. Its commencement clause brings the specification into effect the day after registration, but it is silent on how previously made disclosures or prior administrative practices are to be treated going forward.

• Administrative flexibility. The instrument leaves substantive administrative processes to the Act and the TGA. Its definition of "proprietary" by reference to TGA Business Services means that any changes to that portal's operation, or later administrative guidance about how to record proprietary formulations, will affect how the specification functions in practice. The specification itself does not include procedural amendment mechanisms or a schedule of review.

For a reader investigating later legislative history or subsequent amendments, the instrument's internal notes caution that the commencement table is confined to the original form, and it contains no retrospective amendment record. Any later changes to the specification or to the Act's disclosure regime would need to be found in later instruments, amending regulations or Acts, none of which are present in the instrument supplied here.

The instrument itself contains no references to litigation, and it records no litigation history within its text. It is a delegated specification made under subsection 61(5D) of the Act (s 3) and its legal role is to supply categories of information that the Secretary may release under subsection 61(5C) of the Act (s 5). The instrument does not create offences, appeal mechanisms, or direct rights of action that would typically generate a body of case law.

Consequently:

• No cases are cited in the instrument. The instrument does not reference judicial decisions, and the text provided here does not identify any litigation challenging its validity, interpretation, or application.

• No reported challenges within the instrument. The instrument contains no express records of stakeholders' challenges, judicial review actions, or administrative appeals against decisions under the instrument.

• Practical implications. Any litigation that might arise in relation to the public release of information under subsection 61(5C) of the Act, which this specification informs, would be brought against actions by the Secretary pursuant to the Act. Such litigation would therefore be governed by the Act, administrative law principles, and any applicable doctrines of official discretion, procedural fairness, statutory interpretation and statutory duty. The specification itself would be a subordinate instrument that a court would construe in light of the Act, but the instrument does not record any judicial interpretation.

• Where to look for disputes. If a reader wishes to locate litigation connected to the practical operation of this specification, the appropriate search path is to examine litigation records concerning s 61(5C) disclosures by the Secretary under the Act, or judicial review challenges to TGA publication practices generally. Those cases, if any, would be reported separately to this instrument and are not referenced in the document provided.

This absence of litigation history in the instrument itself is consistent with its technical role as a subordinate specification. Any disputes over disclosure, the meaning of "proprietary" identifiers in TGA Business Services, or the sufficiency of Register entries would be litigated under the Act and general administrative law channels, not within this instrument's text.

This specification is short and technical, but it contains several provisions that can be overlooked or misunderstood. The following are concrete traps and precise points to watch for, all grounded in the instrument's text.

1. Proprietary status is administrative, not an abstract confidentiality test. The instrument defines "proprietary colour", "proprietary flavour" and "proprietary fragrance" as a formulation that is identified as a proprietary ingredient in TGA Business Services (s 4). That means the legal treatment in the Schedule depends on an administrative designation in a particular portal. If a sponsor believes a formulation is commercially sensitive but has not ensured it is identified appropriately in TGA Business Services, the Schedule will not treat it as proprietary for the purpose of subsection 61(5C).

2. Active versus other items have different disclosure scopes. For medicines, the Schedule requires the name and amount of each active ingredient, but only the name of each other ingredient (Schedule 1 Part 1 items 1 and 2). For biologicals, the same split applies: name and amount for active components, name only for other components (Schedule 1 Part 2 items 1 and 2). If a sponsor wants to avoid disclosure of amounts, that is only possible for non-active ingredients/components; the Schedule mandates amounts for active moieties.

3. The single-word representation for proprietary items is limited to colour, flavour and fragrance. Schedule items 3 to 5 in both Parts 1 and 2 state that where a relevant medicine or biological contains a proprietary colour, flavour or fragrance, the information released will be the single word "colour", "flavour" or "fragrance". The Schedule does not provide the same generic treatment for other categories of proprietary formulations. Sponsors cannot assume a blanket generic treatment for other proprietary excipients or carriers unless those are separately identified as proprietary colours, flavours or fragrances in TGA Business Services.

4. The instrument applies only to goods included in the Register. The definitions of "relevant medicine" and "relevant biological" are expressly tied to inclusion in the Register (s 4). The specification therefore does not apply to therapeutic goods not included in the Register; do not assume applicability to unregistered, unlisted or exempt goods.

5. The instrument does not create a duty to submit ingredient amounts to the Register. While the Schedule identifies amounts of active ingredients/components as kinds of information that may be released under subsection 61(5C), the instrument itself does not legislate the content of Register entries or prescribe submission obligations. Those obligations, and any penalties for omission or inaccuracy, are found in the Act and the Regulations. Do not look to this instrument for enforcement or submission detail.

6. TGA Business Services is the determinative administrative source. The instrument provides a specific internet reference for TGA Business Services and ties proprietary status to that service (s 4). Changes in how that portal operates, including access levels or procedural rules, will affect the practical operation of the specification. Administrative changes to the portal can thereby change the practical effect of the specification without amending the instrument.

7. The instrument is silent on format, timing and process for releases. It specifies kinds of information, but not the format for publication, the timing, or redaction processes, and it does not prescribe internal TGA decision-making criteria about when the Secretary will exercise the s 61(5C) disclosure power. Operational uncertainty as to those procedural matters remains and must be resolved by reference to the Act, TGA policies, or administrative practice.

8. No mention of amounts for "other" items. The instrument deliberately does not require the amounts of "other ingredients" or "other components" to be specified in any release; only names are in the Schedule (Schedule 1 Part 1 item 2; Part 2 item 2). If stakeholders expect quantitative disclosure across the board, that expectation will not be met under this specification.

9. The instrument does not override other legal claims to confidentiality. Because it simply specifies kinds of information for a statutory release power, it does not displace other legal protections or claims. If, for example, a sponsor seeks to assert that publicly releasing a particular ingredient name would breach some other statutory confidentiality, that is not resolved by the specification; the conflict must be addressed in the Act or other applicable law.

10. The instrument relies on definitions external to its text. It refers to the Act for the meaning of "therapeutic goods information" and to the Regulations for the meaning of "active ingredient" (s 4). Users must consult those instruments to interpret the specification fully. A failure to consult may lead to misapplication.

These are practical, source-grounded points. They highlight places where a sponsor, regulator or adviser needs to check administrative records, submission practices, and the Act and Regulations to determine the actual disclosure outcome in any given case.

Compliance under this specification is procedural and record-focused, because the instrument specifies what kinds of information the Secretary may release under subsection 61(5C) of the Act and anchors "proprietary" status to the TGA Business Services portal. The specification itself does not create submission obligations, but it does create clear administrative consequences for how records are maintained. Steps for practical compliance, grounded in the instrument, are:

1. Audit Register entries and product dossiers. The Schedule ties public-release categories to goods "included in the Register" (s 4). Sponsors should confirm that the Register entries for each product accurately reflect active ingredients/components by name and amount, and the names of other ingredients/components. This is because the Schedule identifies these categories as the kinds of information the Secretary may release under s 61(5C) (s 5 and Schedule 1).

2. Identify proprietary colours, flavours and fragrances in TGA Business Services if generic disclosure is intended. The instrument defines proprietary colour, flavour and fragrance by reference to identification in TGA Business Services (s 4). If a sponsor expects, or desires, that the public disclosure reflect only the single-word generic indicator "colour", "flavour" or "fragrance", the sponsor must ensure the formulation is recorded as a proprietary ingredient in TGA Business Services in accordance with the portal's procedures.

3. Maintain consistent internal documentation linking TGA Business Services entries to Register data. Because the specification gives legal effect to the TGA Business Services identification, sponsors should ensure that internal records can show where and how a formulation has been identified in the portal. That will be relevant in any challenge to the Secretary's decision to treat a formulation as proprietary for release purposes.

4. Check the Regulations and the Act for submission and accuracy obligations. The specification defers to the Regulations for the meaning of "active ingredient" and to the Act for the meaning of "therapeutic goods information" and the power to release it (s 4 and s 5 notes). Sponsors should review the Act and Regulations to determine legal obligations to provide composition data to the Register and the consequences of inaccurate or misleading entries.

5. Coordinate product labelling and Register records. Because the specification bridges Register data and public disclosure, inconsistencies between product labels and Register entries could lead to undesirable public releases. Sponsors should align labelling information, regulatory submissions and Register entries to avoid inadvertent exposure.

6. Implement procedural checks for TGA Business Services submissions. Where proprietary formulations are sensitive, develop internal controls around who can make identifications in TGA Business Services, and maintain records of when and how those identifications were made. The instrument makes the portal the determinative source for proprietary status (s 4), so governance over entries in that portal is a compliance priority.

7. Prepare for active ingredient/component disclosure. The Schedule requires the name and amount of each active ingredient/component to be the kinds of information specified for release (Schedule 1 Part 1 item 1; Part 2 item 1). Sponsors should therefore be ready for such disclosures to be made by the Secretary, subject to the Act's decision to release under subsection 61(5C).

8. Seek clarity from the TGA on procedural matters not covered by the instrument. Because the specification does not set out the format, timing or decision criteria for release, sponsors with material commercial concerns should seek administrative guidance from the TGA about how the Secretary exercises s 61(5C) and how the TGA Business Services portal implements proprietary identifications.

9. Legal review where confidentiality overlaps with other regimes. If a sponsor believes there is a legal basis to prevent a particular public release under another statute or established confidentiality law, they should obtain legal advice because the specification itself does not resolve such conflicts. The instrument simply identifies the types of information available for release; any statutory conflicts must be assessed against the full legal framework.

10. Record retention and transparency. Maintain records sufficient to demonstrate that entries in the Register and TGA Business Services were accurate and properly authorised. Should a public release occur under the Act, well-kept records will be the primary evidence to explain the sponsor's position.

In short, compliance under this instrument means: ensure the Register and TGA Business Services accurately reflect the sponsor's composition data and proprietary identifications, be prepared for release of active ingredient names and amounts, and use the TGA Business Services portal deliberately when claiming proprietary status for a colour, flavour or fragrance. The specification delegates many procedural and enforcement matters to the Act, Regulations and administrative practice, so sponsors should align their regulatory record-keeping and corporate controls to those broader regimes.