Therapeutic Goods (Information Specification—Testing of Goods) Instrument 2025

The instrument rests on a small number of definitional and operational concepts that determine its application.

• “Therapeutic goods information,” the central subject, is the term given by subsection 61(1) of the Act. This instrument specifies categories and instances of such information that the Secretary may release under the Act (section 5(1) and (2)).

• “Analyst’s certificate” is treated as a discrete kind of therapeutic goods information. The instrument uses the term in Schedule 1, item 1, and defines it by reference to the TG Regulations (section 4(1)). That certificate is the means by which an analyst records testing conducted under the TG Regulations, and the instrument allows information in that certificate, including a copy, to be released to named parties.

• “Sample” is defined expansively. Section 4(2) treats a sample as including part of a sample. Sections 4(3) and 4(4) extend the definition of a sample and testing to cover samples and testing obtained or conducted under the Act, under the TG Regulations or MD Regulations, and samples or testing performed by or at the request or instruction of a Commonwealth officer, including under the exercise of executive power. This framing means the information power covers testing that arises through regulatory sampling and testing, and testing initiated by Commonwealth officers.

• Discretion versus obligation. The instrument uses permissive language, emphasising that specific kinds of information “may be released” (section 5(1) and 5(2)). The Secretary’s power to disclose is exercised under the Act; this instrument specifies the kinds of information and recipients. The instrument does not, on its face, convert that permissive power into an obligation to disclose in particular circumstances. The structure therefore separates the specification of information types from the decision to disclose.

• Scope of public disclosure. Schedule 2 is broad in the types of information that may be released to the public. It covers: descriptive identification of goods; presentation and composition; ingredient or component information; detailed sample descriptors (including condition, dates, batch/lot numbers); provenance or chain of custody matters; sponsor, manufacturer or supplier identity; product information and instructions; and information about the conduct, scope, results and outcomes of testing (Schedule 2, items 1 and 2). The instrument therefore contemplates public disclosures that are both technical and commercially sensitive.

• Repeal of prior specification. Schedule 3 repeals the Therapeutic Goods Information (Laboratory Testing) Specification 2017 in full. The repealed instrument is not preserved in part; the entire prior instrument is removed from the statutory framework as of commencement.

Those concepts determine the operational reach of the instrument: what documents and data fall within the disclosure regime, who may receive them, and the broad content categories for public release.

The instrument directly affects a defined set of actors by designating recipients of information and by defining the classes of information that may be released.

• The Secretary of the Department of Health, Disability and Ageing is the decision-maker who may release therapeutic goods information under the instrument. Section 3 records the authority for the instrument as subsections 61(5AB) and (5D) of the Act; section 5 implements the Secretary’s power by identifying what may be released and to whom.

• Sponsors of therapeutic goods are an explicit recipient in Schedule 1, item 1(b). Schedule 2 also contemplates public disclosure of information relating to sponsors (item 1(d)). Sponsors therefore may receive analyst’s certificates and may have identifying and product information disclosed to the public.

• Persons from whom a sample was taken, collected, received or otherwise obtained are designated recipients under Schedule 1, item 1(b). The instrument therefore provides for direct communication of analyst’s certificate information back to the source of the sample.

• Persons who provided access to a sample for testing are named recipients under Schedule 1, item 1(c). The instrument contemplates that parties who assisted in obtaining access to a sample may be informed of testing conducted, results, or other information in an analyst’s certificate.

• Manufacturers, suppliers and, if applicable, persons in relation to whom goods are registered, listed or included in the Register are affected insofar as Schedule 2 expressly lists information about the sponsor, manufacturer or supplier as information that may be released to the public (item 1(d)). This includes potential disclosure of product information, instructions, packaging, and manufacturing or supply-related information (item 1(e) and (f)).

• Analysts and laboratories fall within the instrument’s scope indirectly. The instrument identifies “analyst’s certificate” as a specified kind of information (Schedule 1, item 1). Analysts will continue to prepare certificates under the TG Regulations; those documents are now explicitly captured as potentially releasable to specified parties.

• Commonwealth officers and bodies involved in testing or sample collection are both sources and recipients. Sections 4(3) and 4(4) explicitly include samples and testing “by, or at the request or on the instruction of, a Commonwealth officer (including in the exercise of the executive power of the Commonwealth).” Schedule 2 item 2(c) also contemplates that information on when, where and by whom testing was conducted may be disclosed, which can include Commonwealth officers.

• The public at large is a recipient under Schedule 2. The Schedule specifies a wide range of information that may be released to the public, from product descriptors and batch identifiers to testing results and regulatory actions taken.

• Persons who provided access to samples, sponsors and manufacturers may bear reputational and commercial effects because the instrument contemplates public release of detailed identifying and technical information (Schedule 2). The instrument therefore affects the information environment in which those private parties operate, with consequences for communications, record-keeping and response protocols.

Actors not explicitly mentioned in the instrument,such as importers other than sponsors, downstream distributors, clinicians, or consumers,may be affected indirectly as recipients of public disclosures, but the instrument’s text identifies sponsors, sample sources or accessors, manufacturers, suppliers, analysts, Commonwealth officers and the public as the primary categories directly targeted.

The instrument sets out what kinds of therapeutic goods information may be released and to whom, but it does not impose new criminal offences or direct statutory duties beyond specifying permitted disclosures under the Act. The following points capture the principal duties and rights that arise from the text.

• Secretary’s discretion to release information. The operative phrasing in section 5(1) and 5(2) is permissive: particular kinds of information “may be released” to specified recipients or to the public. The instrument therefore defines the scope of lawful disclosure under the Act but does not itself require disclosure in specific circumstances. The Secretary retains decision-making authority within the parameters set by the Act and this instrument.

• Right of certain parties to receive analyst’s certificate information. Schedule 1, item 1 expressly lists “information in an analyst’s certificate, including a copy of the certificate itself” as a kind of information that may be released to the sponsor, the person from whom the sample was taken, or the person who provided access to the sample. Those parties therefore have a designated pathway to receive laboratory-certificate information, subject to the Secretary’s exercise of discretion.

• Public disclosure rights. Schedule 2 lists broad categories of information that the Secretary may make public. The categories include identification and descriptive details of goods, sample characteristics and identifiers, chain-of-custody details about how the sample was obtained, product information and instructions for use, and testing-related information (reasons for testing, test descriptions and scope, who performed the testing, results, compliance findings and outcomes such as further testing requirements or regulatory actions). The practical effect is that the public may be provided with comprehensive data about tested goods and testing processes.

• No express private right to prevent disclosure in this instrument. The instrument does not create a statutory right for a sponsor or other party to prevent disclosure. It specifies what may be released but does not set out mechanisms for challenging a proposed release, for redaction, for confidential treatment or for delay. Those procedural elements, if any, would derive from the Act or other legal regimes, not from this instrument’s text.

• Interaction with TG Regulations. The instrument explicitly references the analyst’s certificate as defined in subregulation 26(1) of the TG Regulations (section 4(1)). Analysts preparing certificates under the TG Regulations therefore generate documents that the Secretary may release to named recipients. The instrument does not alter how analyst’s certificates are produced; it identifies them as a releasable class of information.

• Definitions that expand reach. Sections 4(2) to 4(4) expand the definition of “sample” and “testing” to include samples obtained or testing conducted under the Act, the TG Regulations or the MD Regulations, or by or at the instruction of a Commonwealth officer. That expansion affects the range of testing events and sample-sources covered by the Secretary’s disclosure discretion.

• Repeal of previous specification. Schedule 3 repeals the 2017 instrument in full. Any rights or expectations created by that prior specification are displaced by the present instrument as of commencement.

In short, the instrument delineates which categories of testing-related documentation and information fall within the Secretary’s power to disclose, identifies likely recipients, and defines the boundaries of covered samples and testing, while retaining the Secretary’s discretion to decide when disclosure is appropriate. The instrument does not on its face create procedural safeguards or new enforcement mechanisms in relation to the disclosure power.

The instrument does not create criminal offences, civil penalties, or an enforcement regime. Its text confines itself to specification of kinds of therapeutic goods information that may be released in the exercise of powers under the Therapeutic Goods Act 1989.

• Absence of penalty provisions. Nowhere in the instrument (sections 1 to 6, or in Schedules 1 to 3) are offences, fines, sanctions or penalty frameworks created or described. The instrument is a specification of information categories and recipients, not a penal provision.

• Enforcement of disclosure decisions. The instrument proceeds from the Secretary’s existing powers under the Act, in particular subsections 61(5AB), 61(5C) and 61(5D) as identified in sections 3 and 5. The instrument sets out what may lawfully be disclosed. Any enforcement of obligations or penalties that may arise from the underlying Act or the TG Regulations is not specified in the instrument. The instrument does not describe appeal rights, administrative review mechanisms or judicial review waivers; those procedural matters must be located in the Act or other statutory or common law processes, which are not reproduced in this instrument.

• Compliance obligations on analysts. The instrument identifies the analyst’s certificate as a releasable document (Schedule 1, item 1). Analysts’ obligations to prepare such certificates originate in the TG Regulations (subregulation 26(1)), a source referenced by the instrument. The instrument itself does not state that analysts have additional disclosure obligations beyond producing the certificate under the TG Regulations, nor does it create penalties for failure to produce certificates.

• Implications for confidentiality and information protection. The instrument authorises release of potentially sensitive commercial and technical information, including batch numbers, manufacturing and expiry dates, product information and instructions (Schedule 2, item 1). The instrument does not set out sanctions for misuse of information after release, nor does it mandate redaction, privacy safeguards or limitation on secondary use. Any remedy or sanction for misuse would therefore depend on other statutory regimes, contract law, or common law causes of action, not on provisions of this instrument.

• Repeal as an enforcement reset. By repealing the 2017 specification in full (Schedule 3), the instrument vacates the earlier specification’s content. If the prior instrument contained procedural details that had been relied upon, those are no longer in effect as of commencement. The instrument itself does not create transitional penalty or compliance enforcement steps as part of the repeal.

In summary, the instrument is regulatory in specifying disclosure categories and recipients, but it does not establish penalties or an internal enforcement regime. Enforcement and remedies relevant to disclosure or misuse of released information must be sought in the Act and other laws that are outside the instrument’s text.

The instrument is expressly connected to the Therapeutic Goods Act 1989 and to the associated regulations. Its operation must be read against those instruments to understand the full legal regime for testing, certificates, and disclosures.

• Authority under the Act. Section 3 states that the instrument is made under subsections 61(5AB) and (5D) of the Act. Section 5 implements subsection 61(5AA) by specifying the kinds of information that may be released to particular persons, bodies or authorities, and subsection 61(5C) by specifying kinds of information that may be released to the public. The instrument therefore functions as a specification required or permitted by those subsections of the Act.

• Reference to TG Regulations. The instrument refers to the Therapeutic Goods Regulations 1990 (TG Regulations) in its definitions. Section 4(1) notes that “analyst” has the same meaning as in the TG Regulations and that “analyst’s certificate” has the meaning given by subregulation 26(1) of the TG Regulations. That linkage means that the content and form of analyst’s certificates are governed by the TG Regulations, while this instrument governs whether and to whom the resulting certificate information may be released.

• Reference to MD Regulations. The instrument also refers to the Therapeutic Goods (Medical Devices) Regulations 2002 (MD Regulations) in defining “instructions for use” and in clarifying that samples and testing undertaken under those regulations fall within the disclosure specification (section 4(1) and 4(3)-(4)). Product documentation required under the MD Regulations (for example instructions for use) is explicitly included among the kinds of information that may be released publicly (Schedule 2, item 1(e)).

• Register and related statutory terms. Section 4’s note indicates that several expressions used in the instrument are defined in subsection 3(1) of the Act, including “Register”, “sponsor”, “manufacturer”, “product information” and “included in the Register”. Schedule 2 item 1(d) contemplates disclosure of information about the sponsor, manufacturer or supplier, and if applicable, the person in relation to whom the goods are registered, listed or included in the Register. Therefore, the instrument operates in a legal ecosystem where identities and regulatory statuses are governed by the Act and the Register provisions.

• Chain of custody and executive power. Sections 4(3)-(4) extend the instrument’s scope to samples or testing performed by or at the request or instruction of Commonwealth officers, including in the exercise of executive power. That cross-links with administrative decision-making and executive activity in other statutes and administrative practice, and it ensures that testing initiated under the government’s executive functions falls within the instrument’s disclosure reach.

• Repeal of prior specification. Schedule 3 repeals the Therapeutic Goods Information (Laboratory Testing) Specification 2017 in full. Where regulated entities previously relied on the 2017 instrument’s detail, they must now look to this instrument and to the Act and related regulations to determine what information may be released and under what authority.

• No express displacement of other secrecy or privacy laws. The instrument does not state that its operation displaces other statutory secrecy, privacy or confidentiality obligations. It does not refer to the Privacy Act or to specific secrecy provisions elsewhere. The instrument therefore sits as a specification of information release under the Act, and any interaction with privacy, secrecy or other disclosure-limiting laws must be determined by cross-reference to those laws outside the instrument.

In effect, the instrument is a targeted specification connected to s 61 powers of the Act and to the TG and MD Regulations. Its work is to define categories of testing-related information that fall within the Secretary’s disclosure discretion, while leaving procedural, privacy and enforcement interactions for the wider statutory scheme.

The instrument records its making and commencement, and the single formal amendment action it takes is repeal of the 2017 specification. The text provides the following concrete elements concerning amendment history.

• Date and maker. The instrument is dated 25 September 2025 and is signed by Lisa Kerr, Acting First Assistant Secretary, Medical Devices and Product Quality Division, Health Products Regulation Group, Department of Health, Disability and Ageing. Section 1 sets the name of the instrument as the Therapeutic Goods (Information Specification,Testing of Goods) Instrument 2025.

• Commencement. Section 2 contains a commencement table specifying that the whole of the instrument commences on 1 October 2025. The table includes a note that it relates only to the instrument as originally made and will not be amended in the table for later amendments.

• Basis in the Act. Section 3 states the legal authority under subsections 61(5AB) and (5D) of the Therapeutic Goods Act 1989.

• Change from prior instrument. Schedule 3, item 1 repeals in full the Therapeutic Goods Information (Laboratory Testing) Specification 2017. The text of Schedule 3 reads: “1 The whole of the instrument. Repeal the instrument.” That is a complete repeal rather than a partial replacement.

• No further amendments recorded. The instrument itself contains no schedule, note or provision that amends other instruments beyond the 2017 repeal. There are no transitional provisions recorded, no savings clauses and no staged commencement items apart from the single commencement date. Section 2(2) notes that any information in column 3 of the commencement table is not part of the instrument and may be edited or inserted in a published version, but that is a housekeeping note about the instrument’s published form rather than an amendment mechanism.

• No amendment history prior to 2025 is recorded in the instrument. The instrument replaces the 2017 specification as of its commencement. The instrument does not contain provisions for future amendment processes; those would follow the ordinary legislative or delegated instrument processes under the Act.

For users tracking regulatory history, the key amendment fact is that the 2017 instrument is repealed in full and the 2025 instrument takes effect from 1 October 2025 as the operative specification of testing-related disclosure categories under the Act.

The instrument does not record or reference any litigation history. There are no cases, judicial reviews, appeals, or determinations set out in the instrument’s text. It contains no annexed judicial decisions, no references to prior case authority, and no statutory findings of fact arising from litigation.

Because the instrument is a delegated instrument made under subsections 61(5AB) and (5D) of the Therapeutic Goods Act 1989, disputes about its operation, including judicial review of particular disclosure decisions made by the Secretary under the Act and this specification, would arise in external proceedings under administrative law or other legal causes of action. Those proceedings, if any, are not recorded in this instrument.

Practitioners seeking litigation-relevant material will need to consult the Act, the TG Regulations, the MD Regulations and any administrative decisions or court records outside the instrument. The instrument itself simply lists the categories of information that may be released and repeals the prior specification; it does not present or summarise any judicial construction or litigation outcome.

The instrument contains several concrete features that create legal and practical risks or points of friction. These are matters of drafting, scope and procedure grounded in the instrument’s text.

• Permissive language leaves discretion unarticulated. Sections 5(1) and 5(2) use “may be released.” The instrument specifies what kinds of information fall within the Secretary’s power to disclose but does not articulate criteria, timelines, notice requirements, or processes for deciding whether to disclose in any given case. The practical consequence is that disclosure decisions will be governed by the Act and by administrative practice, but the instrument itself does not provide procedural guardrails.

• Broad definition of “sample” and “testing.” Sections 4(2)-(4) treat a sample as including a part of a sample and include samples and testing obtained under the Act, the TG Regulations or the MD Regulations, or by or at the request or instruction of a Commonwealth officer. That wording means that samples obtained as part of regulatory interventions, as well as samples accessed by Commonwealth officers in the exercise of executive power, are within scope. The consequence is a wide net for what events may trigger disclosure.

• Analyst’s certificate as a releasable document. Schedule 1, item 1 explicitly allows information in an analyst’s certificate, including a copy of the certificate, to be released to sponsors and to persons involved in obtaining the sample. Analysts producing certificates under the TG Regulations should be aware their output may be shared beyond the regulatory file. The instrument does not specify redaction rules or chain-of-custody documentation requirements associated with such releases.

• Public release of potentially identifying and commercially sensitive data. Schedule 2 permits disclosure to the public of manufacturer, sponsor and supplier information, batch or lot numbers, dates of manufacture or expiry, and product documentation including instructions for use and packaging information. It also contemplates release of test results and outcomes, including actions taken under the Act or the Regulations. These items could produce reputational or commercial consequences for sponsors and manufacturers. The instrument does not set out notice periods, right to comment, or right to confidentiality when such information is released.

• No procedural protections specified for third-party confidential information. The instrument does not include mechanisms for stakeholders to apply for non-disclosure, confidentiality protections, or redaction of trade secrets or commercially sensitive elements before public release. If such procedural protections exist, they must be found in the Act or other instruments, not in this specification.

• Repeal of the 2017 instrument without transitional provisions. Schedule 3 repeals the 2017 instrument in full. The 2025 instrument contains no express transitional provisions. Entities that had established processes based on the 2017 instrument will need to map those processes to the 2025 specification from the commencement date.

• Potential for mismatch between analyst outputs and disclosure categories. The instrument ties to an analyst’s certificate as defined in the TG Regulations. If analyst certificates lack standardisation or contain variable levels of detail, the Secretary’s disclosure choices may produce inconsistent public disclosures. The instrument does not prescribe standard content or formatting beyond relying on the TG Regulations’ definition.

• Interaction with privacy and secrecy laws not specified. The instrument does not state whether or how privacy obligations under other legislation or confidentiality obligations under contracts or other statutes might limit disclosure. Practitioners should not assume the instrument displaces other legal duties; rather, these matters will require cross-reference to other legal regimes.

• Absence of penalty or misuse safeguards in the instrument. The instrument does not include sanctions for post-release misuse of information nor do its terms restrict secondary uses. Any enforcement or remedy for misuse of disclosed information must be sought under other statutory or common law avenues.

Those features are concrete drafting elements that will determine how disclosure powers are exercised and resisted in practice.

Compliance under this instrument is primarily about readiness for disclosure and about record-keeping, communications and operational adjustments that follow from the instrument’s specified disclosure categories. The instrument does not draft new offences or procedural duties, but it does identify what the Secretary may release. Practical compliance steps that flow directly from the instrument are as follows.

• Review and update record-keeping for product identifiers and documentation. Schedule 2 item 1(a)-(c) contemplates public disclosure of information that identifies goods and the sample, including batch/lot numbers, date of manufacture or expiry, descriptions and ingredients. Sponsors, manufacturers and suppliers should ensure their records, including batch records and product information files, are current, accurate and accessible to enable prompt response if the Secretary intends to release material.

• Prepare to receive analyst’s certificates. Schedule 1, item 1 permits release of information in an analyst’s certificate, including copies, to sponsors and to persons from whom a sample was taken or access was obtained. Sponsors and sample-providers should confirm contact points for receipt of such certificates and set internal protocols for reviewing and responding to analyst reports.

• Ensure product information, instructions and packaging files are inspection-ready. Schedule 2 item 1(e) lists product information, instructions for use, directions for use, operational manuals, advertising material and packaging information as items that may be released. Sponsors and manufacturers should maintain up-to-date versions of these materials and track where they differ between markets, as disclosures may reference the specific documents associated with the tested sample.

• Document chain of custody and sampling procedures. Schedule 2 item 1(c) contemplates disclosure of how the sample was obtained, accessed or received by the Department or the testing person. Entities involved in sample collection, supply chain custody or access should maintain clear logs and documentation to establish provenance and to be able to comment if public statements draw on those records.

• Coordinate legal and communications planning. Because the instrument permits public disclosure of test results and related outcomes, sponsors and manufacturers should prepare communication strategies and legal briefings that can be deployed quickly in the event of public release. The instrument does not guarantee notice, so practical arrangements for rapid engagement with the Department and for public communications are prudent.

• Confirm compliance with TG and MD regulatory obligations. The instrument hinges on materials generated under the TG Regulations and MD Regulations, and on analyst’s certificates created under subregulation 26(1) of the TG Regulations. Manufacturers and testing laboratories should ensure they meet those regulatory obligations so that any documents the Secretary may disclose are supported by proper regulatory processes.

• Audit contractual confidentiality clauses. Entities with confidentiality obligations to third parties should review contracts governing supply chains and testing arrangements, particularly where those agreements could be affected by public disclosure. The instrument does not displace contractual rights; however, it creates a public law route for release that parties should factor into contractual risk allocation.

• Put in place internal redaction and review protocols. Although the instrument does not prescribe redaction rules, parties likely to be the subject of disclosures should identify what parts of their records might be commercially sensitive and prepare internal templates for rapid legal review. That will facilitate faster engagement with the Department if there is a question of confidential content in documents the Secretary proposes to release.

• Monitor Department publications and points of contact. Given that Schedule 2 contemplates public release of detailed testing information, sponsors and manufacturers should monitor the Department’s public channels and maintain updated contact details to ensure timely receipt of any analyst’s certificates or advance notice if provided.

• Seek legal advice on procedural remedies. If a party considers the Secretary’s exercise of disclosure power to be improper in a particular case, remedies will lie, if at all, under the Act, administrative law or other legal mechanisms. Parties should consult counsel promptly to identify whether there are administrative review processes, judicial review grounds or other legal avenues.

These compliance steps are practical responses to the categories of information and recipients the instrument identifies. They are grounded in the instrument’s content and in the reasonable anticipation that the Secretary may exercise disclosure powers under the Act in respect of the listed items.