Therapeutic Goods (Listed Medicines—Compliance Reviews) Specification 2019

The instrument revolves around a small set of statutory and operational concepts. These are defined or invoked by reference to the Act and the Regulations, and they determine both the scope of the TGA’s post‑market activity and the categories of information that may be made public.

• Therapeutic goods information. The instrument links to the Act’s definition (s 4: “therapeutic goods information has the meaning given by subsection 61(1) of the Act”) and specifies particular kinds of that information for publication under s 61(5C) (s 5). The specification is therefore an exercise of the power in subsection 61(5D) to list kinds of information that may be released.

• Compliance review. The instrument defines “compliance review” as a post‑market review carried out by the TGA for the purpose of determining whether certain requirements of the Act applicable to the medicine have been, or are being, complied with (s 4). The note to the definition gives an example: verifying a sponsor’s certification under s 26A or 26AB of the Act. Hence the compliance review sits within existing post‑market verification and enforcement processes.

• Listed medicine. The instrument applies only to medicines that are “listed goods” on the Register (s 4). It does not apply to registered medicines or non‑therapeutic goods; the subject is limited to the “listed medicines” part of the Register.

• Relevant sponsor and relevant medicine. The instrument repeatedly uses the terms “relevant sponsor” and “relevant medicine” to link the published information to the sponsor in whose name the entry is listed and to the specific listed medicine under review (s 4).

• Publication categories. Schedule 1 sets out 16 information categories that the Secretary may disclose (Schedule 1, items 1-16). These categories range from pure identifiers (name, listing number) through process information (review type, information reviewed, dates), outcome information (review outcome, action taken, grounds for cancellation), to consumer‑facing material (consumer advice on continued use and required action).

• Discretionary release under s 61(5C). The specification designates kinds of information “for the purpose of subsection 61(5C) of the Act” (s 5). The instrument therefore interacts with the Act’s public‑release discretion: it defines the kinds of therapeutic goods information that can be released, but the Act retains the mechanism and discretion for release under s 61(5C) (see s 5 note).

• Repeal of earlier specification. The instrument repeals the 2012 specification in whole (Schedule 2). By replacing the older instrument with this broader Schedule 1, the delegate clarifies the current set of publishable fields for compliance reviews of listed medicines (Schedule 2).

Those are the structural concepts the instrument relies on. Each of these is tied to named provisions in the instrument: the definitions in s 4, the specification in s 5 and Schedule 1, the authority in s 3 (subsection 61(5D) of the Act), and the repeal in Schedule 2.

The instrument affects distinct groups by function: the Secretary and the TGA as decision makers and publishers, sponsors of listed medicines who are the subjects of compliance reviews, consumers who may rely on published consumer advice, and the public users of the TGA website where outcomes may be published.

• Therapeutic Goods Administration and the Secretary. The Secretary has the statutory power to release therapeutic goods information under s 61(5C) of the Act, and the instrument specifies what kinds of information fall within that power in relation to compliance reviews (s 3; s 5). The TGA will therefore decide when and whether to publish items from the Schedule following a compliance review and administer the publication process (see s 5 and Schedule 1 item 15 identifying the TGA website as the publication point).

• Sponsors of listed medicines (relevant sponsors). The specification directly references the “relevant sponsor” as the person in whose name the medicine is listed (s 4). Schedule 1 includes sponsor identity (item 6), actions taken by the sponsor during the review (item 11(a)-(d)), updates made by the sponsor (item 11(a)-(b)), and requests by the sponsor for cancellation (item 11(c)-(d)). Publication of these fields means that sponsors will potentially have information about their products and their responses to compliance reviews placed in the public domain.

• Consumers. Schedule 1 includes consumer‑facing categories: consumer advice in relation to continued use (item 4) and consumer advice in relation to required action (item 5). These items are specified as recommendations to consumers, including reasons and circumstances for safety or actions such as seeking medical advice or disposing of the product. The instrument therefore contemplates publishing material directed at consumer behaviour following a compliance review.

• Commercial third parties and market actors. Identification data (name and listing number, items 1-2), details of efficacy and safety issues (items 9-10), and actions, including cancellations and grounds for cancellation (items 11-13), mean competitors, distributors, retailers, insurers and others may be able to use published compliance review outcomes in commercial, contractual or reputational decisions. The instrument enables such downstream actors to access standardised categories of information via the TGA website (Schedule 1 item 15).

• Regulators and enforcement partners. Although the instrument does not itself create new enforcement powers, the publication categories include summaries of contraventions and grounds for cancellation (items 9-13). Other regulators, health professionals and industry bodies may therefore engage with the published outcomes in exercise of their own responsibilities.

The instrument does not create a new class of regulated person; it operates within the existing sponsor/medicine relationship on the Register. It does, however, increase the potential for public dissemination of sponsor‑specific compliance review outcomes and consumer advice, by setting out specific categories the Secretary may publish (s 5; Schedule 1).

The specification does not create new statutory duties or private rights of action. It operates within the Act’s information‑release framework and therefore affects duties and rights only insofar as it determines what information may be released under s 61(5C). The instrument should be read alongside the Act for the operative duties and rights, but the instrument itself establishes the following practical duties and entitlements.

• Secretary’s power to release specified kinds of information. The instrument specifies kinds of therapeutic goods information that may be released under subsection 61(5C) of the Act (s 5). That specification is an enabling instrument defining the scope of publishable categories; it gives the Secretary the entitlement to publish the listed kinds of information in relation to compliance reviews and the practical duty to adhere to the specified categories when releasing information.

• TGA’s conduct of compliance reviews. The instrument defines “compliance review” and notes that such reviews are post‑market reviews carried out by the TGA for the purpose of determining compliance with requirements of the Act (s 4). The TGA therefore retains its existing procedural role in carrying out reviews, and the instrument clarifies which outputs of those reviews can be made public.

• Sponsor’s certification and evidentiary upkeep. The instrument notes that a compliance review may include verifying the certification made by a sponsor under sections 26A or 26AB of the Act (s 4 note). Sponsors therefore remain subject to the underlying Act’s documentary and certification requirements , a compliance review may examine those materials and the outcomes of that examination are among the kinds of information listed for possible publication (Schedule 1 item 8, item 11).

• Publication of consumer advice and consequent informational duty. Schedule 1 includes consumer advice categories (items 4-5). Where the Secretary elects to publish such material, the Secretary (and the TGA operationally) will provide recommendations and reasons intended for consumers. The instrument itself does not prescribe the content of those recommendations beyond the broad descriptors in Schedule 1, but it creates an expectation that consumer‑oriented statements arising from a compliance review may be published.

• Sponsor actions recorded. Schedule 1 specifically contemplates and lists actions the sponsor may take during the review and for the sponsor to request cancellation of listing (item 11). The Secretary may publish these sponsor actions, which means sponsors’ remedial steps or decisions to withdraw listings can become public.

• No statutory private rights or penalties added. The instrument does not enact offences or civil remedies; it operates as a specification for information release under existing Act powers. It neither creates new enforceable duties against third parties nor confers a private right to require publication. Any legal consequences of publication, such as reputational or commercial effects, are not created by the instrument itself.

In short, the instrument defines what may be published following a TGA compliance review, preserves the TGA’s operational role in conducting reviews, and records sponsor actions as publishable items, but it does not by itself alter statutory obligations or penalties that are set out elsewhere in the Act.

This specification does not create new penalties, civil liabilities or criminal offences. It is an information‑specifying instrument made under subsection 61(5D) of the Act and focussed on the categories of therapeutic goods information that may be released following a compliance review (s 3; s 5). Accordingly:

• No enforcement powers are introduced. The instrument itself does not add enforcement mechanisms or expand the TGA’s enforcement powers beyond the Act. Where the Schedule refers to contraventions (Schedule 1 items 9 and 10 reference “contraventions of the Act”), it does so as a type of information that may be summarised for publication; it does not create new contraventions or new penalties.

• Existing enforcement regime remains in force. The instrument notes that compliance reviews are post‑market reviews by the TGA and may, for example, verify certifications under sections 26A or 26AB of the Act (s 4 note). Any legal penalties or enforcement steps arising from contraventions remain those prescribed in the Act and Regulations. The specification is limited to what may be released publicly about the outcomes of such reviews.

• Publication as an administrative consequence. The primary administrative consequence the instrument effects is the possibility of publication of categories such as “review outcome” (Schedule 1 item 3), “issues relating to safety” and “issues relating to efficacy” (items 9-10), “actions taken during the review” including cancellation (item 11), and “grounds for cancellation” and “date of cancellation” (items 12-13). These are administrative disclosures, not penalties, but publication can have indirect consequences such as reputational harm, market responses or prompting of third‑party regulatory action. Those downstream consequences are external to the instrument.

• Secretary’s discretion and procedural fairness. The instrument does not set procedural rules for when publication must occur or the process to be followed when deciding to publish particular items. It merely specifies categories of information for the purpose of s 61(5C). Any procedural constraints, internal review processes or information‑protection considerations remain matters for the Act and the TGA’s policies and administrative practice rather than the instrument itself.

• Repeal of prior specification has no penalties attached. The repeal of the 2012 instrument (Schedule 2) simply removes the earlier specified list of publishable items and replaces it with the current Schedule 1; it contains no transitional enforcement steps or penalties.

To locate any penalties that might arise from facts disclosed in a compliance review (for example, contraventions summarised in Schedule 1 items 9-10), one must consult the Act and Regulations. This specification does not substitute for those provisions nor does it create novel enforcement mechanisms.

The specification is tightly framed to operate as an adjunct to the Therapeutic Goods Act 1989 and the Regulations; its legal force derives from the Act. Its interactions with other laws are therefore mediated by the Act and the existing regulatory architecture.

• Operative link to s 61 of the Act. The instrument is made under subsection 61(5D) of the Act (s 3) and its specified kinds of information are listed “for the purpose of subsection 61(5C) of the Act” (s 5). Subsection 61(5C) is the Act’s disclosure mechanism; this specification determines the categories of “therapeutic goods information” that the Secretary may release following a compliance review. The specification does not, and cannot, override any limits or procedures in s 61 itself. Any interaction with privacy, secrecy, or other protective provisions must be managed within the Act’s framework.

• Relationship to certificate and listing provisions. The instrument explicitly notes that a compliance review may include verifying a sponsor’s certification under s 26A or 26AB of the Act (s 4 note). That connects the specification to those sections of the Act concerning sponsor certification and to s 31 (the instrument references a request for information under s 31 in Schedule 1 item 11(d)). Therefore the specification will be operationalised in statutory contexts where sponsors have obligations under those sections.

• Publication versus secrecy and confidentiality regimes. The instrument specifies that publication will occur on the TGA website (Schedule 1 item 15). It does not address how publication interacts with statutory secrecy or confidentiality protections elsewhere in Commonwealth law, such as the Privacy Act 1988 or the Act’s own secrecy provisions. Any such limits on disclosure must be resolved by reference to those laws and the Secretary’s obligations under the Act. The specification does not itself abrogate other legal confidentiality requirements.

• Interaction with administrative law. Decisions to publish particular kinds of information may be subject to administrative law considerations , procedural fairness, reasonableness, and reviewability , if challenged in court. The instrument does not set out procedural guarantees or appeal rights in relation to publication decisions; those are determined by the Act, administrative law principles and related Commonwealth legislation. The specification merely identifies what kinds of information may be published.

• Overlap with consumer protection and advertising law. Schedule 1 includes “promotional and advertising material” among examples of information that may be reviewed (item 8) and contemplates publication of issues relating to efficacy or contraventions (items 10, 9). Where a published outcome discloses an apparent breach of advertising law or consumer protection law, other statutory bodies (for example the Australian Competition and Consumer Commission or state health regulators) might have jurisdiction; the specification does not alter those bodies’ powers but it creates a source of publicly available material that could be used in enforcement or compliance monitoring by other regulators.

• Repeal of the 2012 instrument. The specification expressly repeals the Therapeutic Goods Information (Outcomes of Compliance Reviews of Listed Complementary Medicines) Specification 2012 (Schedule 2). That repeal replaces the previous listed fields with the current Schedule 1, and so any legal or administrative processes that relied on the 2012 instrument must now accommodate the new list as the operative catalogue for publishable information under s 61(5C).

In every interaction that involves release of information, the overriding statutory constraints, including any applicable secrecy, privacy or confidentiality provisions, remain those in the Act and other Commonwealth legislation; the specification neither enlarges nor nullifies those constraints but defines the classes of information that are within the Secretary’s power to disclose after a compliance review.

This instrument itself is a discrete amendment to the statutory disclosure framework, effected by replacing the earlier 2012 specification. The instrument contains its own commencement and repeal history consistent with legislative instruments practice.

• Commencement. The instrument commences the day after it is registered (s 2(1)). The instrument contains the standard note that the commencement table relates only to the instrument as originally made (s 2(2) notes that column 3 is not part of the instrument and can be edited in published versions).

• Authority. It is made under subsection 61(5D) of the Therapeutic Goods Act 1989 (s 3). The specification therefore sits as a delegated instrument under the Act’s information disclosure provisions.

• Repeal of 2012 instrument. Schedule 2 expressly repeals “The whole of the instrument” comprising the Therapeutic Goods Information (Outcomes of Compliance Reviews of Listed Complementary Medicines) Specification 2012 (Schedule 2). That repeal is absolute as phrased: “Repeal the instrument.” There are no transitional provisions in this instrument that preserve aspects of the 2012 document. The effect is that the current Schedule 1 replaces the earlier specification as the operative list of publishable items for compliance review outcomes.

• No other amendments recorded. The instrument does not record amendments to other instruments or to the Act; it is a focused specification and repeal instrument. There is no schedule amending substantive provisions of the Act or Regulations.

• Publication and record. Schedule 1 item 15 contemplates publication of the specified information on the TGA website; the instrument therefore anticipates that the practical effect of the amendment will be implemented by the TGA’s publication practices. The instrument itself does not set out versioning, but standard legislative practice would place this instrument and its repeal of the 2012 instrument on the Federal Register of Legislation where subsequent amendments would be recorded.

In short, the amendment history contained within the instrument is limited to the replacement of the 2012 specification with the current Schedule 1, and to its commencement the day after registration. No staged transition, grandfathering, or additional amendment steps are provided in the text.

The instrument contains no internal references to litigation, judicial interpretation, or precedential cases. It does not name any cases. The text includes no description of past legal disputes or court decisions regarding disclosure of compliance review outcomes. As an administrative specification of information categories under s 61(5D) of the Act, it functions as an enabling list rather than a judicial rule that has generated case law within the instrument itself.

Because the instrument is limited to specifying kinds of therapeutic goods information, any litigation likely to arise from its operation would be about the exercise of discretion under the Act (for example, whether the Secretary lawfully released particular information under s 61(5C), or whether confidentiality or privacy restraints were properly applied). The instrument does not itself articulate procedural constraints or remedies, and therefore does not document litigation history. To find any litigation that engages the instrument’s categories, one must search judicial decisions addressing s 61 publication decisions or TGA disclosure practice; no such decisions are recorded in this specification.

Accordingly, within the four corners of the instrument, there is no litigation history to report. The specification is a declarative catalogue of publishable categories and a repeal of the earlier instrument, not a body of case law.

This instrument is short and narrowly focussed, but there are several practical points and implementation risks that users should note, all supported by the instrument’s text.

• Specification does not equal mandatory publication. The instrument specifies the kinds of therapeutic goods information that may be released for the purposes of subsection 61(5C) of the Act (s 5). It does not require publication of every item for every review, nor does it set out criteria or process for deciding which items to publish. The discretion to release remains with the Secretary under the Act; the specification only defines the categories that fall within that power.

• Publication may include sponsor‑sensitive information. Schedule 1 lists sponsor identity (item 6), issues relating to safety and efficacy including contraventions (items 9-10), and actions taken during review including cancellations and grounds (items 11-13). These items can include commercial and compliance information that sponsors may consider sensitive. The instrument does not create protections for commercially sensitive or proprietary information; any limitation on disclosure would need to be found in the Act or other law governing confidentiality or privacy.

• Consumer advice is an express category. Schedule 1 items 4 and 5 envisage public recommendations to consumers, including reasons and circumstances for their safe use or required actions. Publication of such advice is categorical in the Schedule; sponsors should expect consumer‑facing messaging to be an operational possibility following a review.

• Review type is public. Schedule 1 item 7 specifies that the review type (random or targeted) may be disclosed. Publication of review type may be interpreted by market actors or the public as indicating systemic concerns or targeted enforcement, despite the instrument not specifying the rationale for selecting targeted reviews.

• The instrument cross‑references other statutory processes. The definition note in s 4 expressly states a compliance review may include verifying certifications under s 26A or 26AB of the Act. Schedule 1 item 11(d) references cancellation following a request for information under s 31 of the Act. Sponsors should therefore read the specification alongside those Act provisions , actions taken under those sections may be recorded and published.

• Publication timing is recorded. Schedule 1 item 14 records the date the outcome was notified to the sponsor (being the date the compliance review was concluded), and item 15 records the date the information was published on the TGA website. This creates a public timeline from internal notification to external publication and may affect communications and commercial decisions in the interim.

• Additional subsequent information may be published. Schedule 1 item 16 allows for “details of any relevant information, actions taken, or decisions made … after the conclusion of the compliance review.” The scope of “additional information” is broad, and the instrument provides no temporal limit. Sponsors could therefore see ongoing updates posted after the initial outcome.

• The instrument does not address privacy/confidentiality limits. Although the specification identifies categories for publication, it does not resolve conflicts with the Privacy Act 1988 or statutory secrecy provisions; the Secretary’s obligations in that regard remain to be considered when deciding whether to publish particular items. The instrument provides no internal test for redaction or non‑publication on confidentiality grounds.

• Repeal is total and without transitional rules. The 2012 instrument is repealed in full (Schedule 2) and the specification becomes the operative instrument. If stakeholders relied on narrower categories in the 2012 specification, they should note that the current Schedule 1 replaces it without transitional protections set out in this instrument.

These points are not judgments about the policy merits of publication but are practical implementation considerations that follow from the instrument’s text. Parties affected by compliance reviews should plan for the possible public disclosure of the categories listed in Schedule 1 and manage records, communications and commercial risks accordingly.

The instrument does not create new statutory obligations but it identifies what the Secretary may publish after a compliance review. Compliance, in practical terms for sponsors and stakeholders, therefore means ensuring records, labels and responses are maintained and capable of withstanding a post‑market review and possible public disclosure. The following steps flow directly from the instrument’s text.

• Maintain accurate identifiers and register entries. Schedule 1 items 1 and 2 identify the name of the medicine and the listing number (ARTG ID) as publishable items. Sponsors should ensure the Register entry is accurate and up to date so that any published identification information is correct.

• Keep complete documentary evidence for indications and claims. Schedule 1 item 8 includes evidence held by the sponsor in relation to indications and claims as an example of information reviewed. Sponsors should keep contemporaneous, well‑organised evidence supporting advertising, indications and any claims made for listed medicines, including labels and promotional material, because those categories can be the subject of review and subsequent publication.

• Ensure label and manufacturing documentation are defensible. Item 8 lists the label and documents relating to manufacture among the types of reviewed information. Sponsors should ensure labels comply with the Act and Regulations and that manufacturing records are current and retrievable in case they are reviewed and summarised in a public outcome.

• Be prepared to record and justify remedial actions. Schedule 1 item 11 lists actions that may be summarised, such as updates to the listing or label, requests for cancellation by the sponsor, or cancellation by the Secretary. Where a sponsor undertakes remedial changes during a review, they should document those changes and the reasons for them because these steps are specifically listed as publishable.

• Anticipate consumer‑facing publication. Schedule 1 items 4 and 5 provide for consumer advice regarding continued use and required action. Sponsors should be ready to engage in clear, factual communications to consumers and distributors if TGA publishes consumer advice in relation to their medicine, and should plan for supply‑chain communications in line with any published recommendations.

• Respond promptly to information requests. Item 11(d) references cancellation following a request for information under s 31 of the Act. Sponsors should have procedures to respond promptly and comprehensively to statutory requests under s 31 to reduce the risk of adverse findings and related publication.

• Monitor TGA publication practices. Schedule 1 item 15 specifies the TGA website as the publication channel. Sponsors should monitor the TGA website for publication of outcomes and dates listed in item 14 (date outcome notified to sponsor) and item 15 (date of publication) to manage communications and any upstream or downstream legal or commercial obligations.

• Control internal processes around certification. The s 4 note identifies verification of certifications under s 26A or 26AB as an example of a compliance review activity. Sponsors should review their certification processes and retain documentary proof in case a compliance review examines those certifications and the TGA publishes information about their verification.

• Prepare for ongoing updates. Item 16 allows publication of additional information arising after the conclusion of the review. Sponsors should not assume publication is a one‑time event; maintain logs and be prepared to update public communications if additional relevant information is later posted by the TGA.

• Seek advice where necessary. Where publication may intersect with confidentiality, privacy or commercial‑sensitivity concerns, sponsors should consider legal advice drawing on the Act’s provisions and broader Commonwealth law. The specification itself does not resolve privacy or confidentiality limits; those will be matters for the Act and other statutes.

These compliance steps are practical responses to the categories the instrument lists as publishable and are grounded in Schedule 1 items and the definition of compliance review in s 4. The specification should be used as a checklist for record keeping, communication plans, and responsiveness to statutory requests and potential publication of compliance review outcomes.