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

EXPLANATORY STATEMENT

Therapeutic Goods Act 1989

The Therapeutic Goods Act 1989 (“the Act”) provides for the establishment and maintenance of a national system of controls for the quality, safety, efficacy or performance, and timely availability of therapeutic goods that are used in, or exported from, Australia. The Act is administered by the Therapeutic Goods Administration (“the TGA”) within the Australian Government Department of Health, Disability and Ageing (“the Department”).

Section 61 of the Act provides that the Secretary may release specified kinds of therapeutic goods information to the public, and to certain organisations, bodies or authorities. Subsection 61(1) of the Act provides that therapeutic goods information means, for the purposes of the section, information relating to therapeutic goods, which is held by the Department and relates to the performance of the Department’s functions.

Subsection 61(5AA) provides that the Secretary may release to a person, body or authority that is specified, or is of a kind specified, under subsection 61(5AB) of the Act, therapeutic goods information of a kind specified under that subsection, for a purpose specified under that subsection. Subsection 61(5AB) relevantly provides that, for the purpose of subsection 61(5AA), the Minister may, by legislative instrument, specify a person, body or authority, the kinds of therapeutic goods information, and the purposes for which the information may be released.

Separately, subsection 61(5C) provides that the Secretary may release to the public therapeutic goods information of a kind specified under subsection 61(5D). Subsection 61(5D) relevantly provides that the Minister may, by legislative instrument, specify kinds of therapeutic goods information for the purpose of subsection 61(5C).

The Therapeutic Goods (Information Specification—Testing of Goods) Instrument 2025 (“the Instrument”) is a legislative instrument made under subsections 61(5AB) and 61(5D) of the Act. It specifies, for the purpose of subsections 61(5AA) and (5C) of the Act respectively:

the kinds of therapeutic goods information that the Secretary may release to specified persons, bodies or authorities, and the purposes for which the Secretary may do so; and
the kinds of therapeutic goods information that the Secretary may release to the public.

Specifically, the instrument specifies that information in a certificate issued by an analyst (“analyst’s certificate”) under subregulation 26(1) of the Therapeutic Goods Regulations 1990 (“the TG Regulations”), may be released to any of the following persons, bodies or authorities, for the purpose of informing them of the testing conducted on the sample, the results of that testing and any other information included in the analyst’s certificate:

the sponsor of the goods tested;
the person from whom the sample tested was taken, collected, received or otherwise obtained;
the person from whom access to the sample was obtained for the purpose of testing.

In addition, the Instrument repeals and replaces the Therapeutic Goods Information (Laboratory Testing) Specification 2017 (“the Former Specification”) to specify a range of therapeutic goods information pertaining to the TGA’s testing activities that may be released to the public. The specified kinds of therapeutic goods information include information relating to samples tested, being tested or that are intended to be tested, and information relating to the testing of such samples.

Background

TGA’s testing program

The TGA’s testing program plays an important role in the regulation of therapeutic goods and vaping goods in Australia. It is critical to a number of the TGA’s functions, including to support and inform:

the pre-market assessment of therapeutic goods for registration, listing or inclusion in the Australian Register of Therapeutic Goods (“the Register”), and batch release of vaccines for release for supply in Australia;
post-market monitoring of therapeutic goods, regardless of whether those goods are in the Register or supplied subject to a relevant exemption, approval or authority—including, for example, compliance testing to ensure that such goods comply with applicable standards or the essential principles;
the investigation of suspected offences against or contraventions of the Act or its regulations—including, for example, to determine whether goods are counterfeit therapeutic goods, or a person has unlawfully supplied therapeutic goods that do not comply with applicable standards; and
regulatory decision-making—including, for example, to assist the Secretary in deciding whether or not to suspend or cancel the registration, listing or inclusion of therapeutic goods in the Register, or to require therapeutic goods to be recalled.

Testing is primarily conducted by the TGA’s Laboratories Branch, which comprises Australian Public Service employees in the Department with qualifications across a broad range of disciplines. However, in some instances, the TGA may arrange for samples to be tested by another appropriate person or body, such as persons in other government departments or agencies, a university, or a laboratory or facility that is a corporate entity. The TGA may do this, for example, during periods of high-volume testing or in circumstances where the other person or body possesses specialised equipment or expertise to test the relevant goods or perform the appropriate tests.

Testing under Part 5 of the Therapeutic Goods Regulations 1990

On 1 October 2025, the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025 (“the Amendment Regulations”) repeals and replaces Part 5 of the TG Regulations, which relates to the testing of samples of goods. The purpose of these amendments, broadly, is to improve the clarity and functionality of Part 5 and make it clearer that Part 5 does not preclude the TGA from testing, or arranging for the testing, of goods other than under that Part. New Part 5 of the TG Regulations includes regulations 23 to 26.

An analyst in the Department may select a sample of goods for testing under regulation 25 in Part 5 of the TG Regulations where the testing is for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations (subregulation 25(1) refers). If an analyst selects a sample of goods for testing under regulation 25, the analyst must test the sample themselves, arrange for another analyst to test the sample, or arrange for the sample to be tested by another appropriate person or body (subregulation 25(2) refers).

If a sample of goods is tested under regulation 25, including as arranged under subregulation 25(2), an analyst must issue a certificate (i.e., an analyst’s certificate) setting out the testing that was conducted and the results of the testing (subregulation 26(1) refers). The analyst’s certificate may also set out other information relating to the sample or the testing of the sample (subregulation 26(2) refers). In proceedings under the Act or its regulations (including proceedings for an offence against the Act or its regulations, or a contravention of a civil penalty provision), an analyst’s certificate is prima facie evidence of the matters set out in the certificate (subregulation 26(6) refers).

If the sample is of therapeutic goods that are registered, listed or included in the Register, a copy of the analyst’s certificate must be given to the person in relation to whom the goods are so registered, listed or included (subregulation 26(5) refers). This is an important transparency measure, as an analyst’s certificate may support and inform a range of regulatory decisions and actions that may affect that person’s interests or rights.

However, the requirement in subregulation 26(5) does not apply in relation to samples of therapeutic goods that are not registered, listed or included in the Register. This is because, in such cases, an analyst may not know, and may be unable to readily ascertain, the identity of the person responsible for, or who arranges, the importation or exportation of therapeutic goods, or the manufacturer of therapeutic goods for supply in Australia (i.e., the sponsor of the goods). Further in some cases, it may not be appropriate to provide the person from whom the sample of therapeutic goods was taken, collected or otherwise obtained with a copy of the certificate if, for example, it would impede investigation of suspected non-compliance with the Act.

Testing may also be conducted outside Part 5 of the Therapeutic Goods Regulations 1990

Importantly, as outlined above, Part 5 of the TG Regulations does not preclude the TGA from testing, or arranging for the testing, of goods other than under that Part (subregulation 23(2) refers). That is, an analyst may choose to test a sample of goods other than under regulation 25, such as where:

testing under that regulation is inappropriate because extraordinary, urgent testing is needed to be done by (or as arranged by) the TGA to address a public health emergency;
the TGA intends to test a sample of goods for a purpose that does not relate to the administration of the legislative framework (including, for instance, testing the TGA performs solely for the purpose of assisting a Commonwealth, state or territory agency in the administration of their own legislation).

Further, testing may also be conducted by an authorised person or authorised officer under certain provisions of the Act, and the TG Regulations and MD Regulations, when the authorised person or authorised officer enters premises and inspects the premises and goods on the premises. For example, it is a condition of the entry of therapeutic goods in the Register that the person in relation to whom the goods are so entered will relevantly allow an authorised person enter premises at which the person deals with the subject goods and, among other things, conduct tests on any therapeutic goods on those premises (paragraphs 28(5)(a), 32EA(1)(a) and 41FN(1)(a) of the Act refer).

Purpose

The purpose of this Instrument is to replace the Former Specification to enable the release of information relating to the testing of therapeutic goods to the public, and to provide for the release of information in an analyst’s certificate to certain persons, bodies or authorities from whom samples of goods are taken for testing.

Schedule 1 to the Instrument is consequential to the amendments made to Part 5 of the TG Regulations by the Amendment Regulations. It supplements subregulation 26(5) of the TG Regulations by enabling the Secretary under subsection 61(5AA) of the Act to release information included in the analyst’s certificate to any of the following persons, bodies or authorities, for the purpose of informing them of the testing conducted on the sample, the results of that testing and any other information included in the analyst’s certificate:

the sponsor of the goods tested;
the person from whom the sample tested was taken, collected, received or otherwise obtained;
the person from whom access to the sample was obtained for the purpose of testing.

Schedule 1 to the Instrument facilitates transparent communication with stakeholders whose goods are the subject of testing under Part 5 of the TG Regulations by, or as arranged by, the TGA. Release to these specified persons, bodies or authorities may, in some cases, be appropriate as they may have an interest in the results of the testing of a particular sample of therapeutic goods. This is particularly the case where the results of the testing identify that the goods are unlawful or indicate that urgent action ought to be taken by one or more of the specified persons, bodies or authorities to resolve or mitigate a potential threat to public health or safety. However, the discretionary nature of this power reflects that, in some cases, it may not be appropriate to release information in the analyst’s certificate to such persons – for example, because it may impact the investigation of non-compliance with the therapeutic goods regulatory framework.

Schedule 2 to the Instrument essentially replaces the Schedule to the Former Specification. It specifies a range of therapeutic goods information relating to the testing of samples that the Secretary may release to the public under subsection 61(5C) of the Act. Broadly, the specified kinds of information include information relating to samples tested, being tested or intended to be tested (as applicable), as well as information relating to the testing of such samples. The purpose of this Schedule is to support transparency and understanding of the regulation of therapeutic goods in Australia, promote consumer confidence in the quality, safety and efficacy or performance of therapeutic goods, and encourage industry compliance with legislative requirements. Publication or release of such information complements other information the TGA publishes, such as early warnings, safety alerts, product recalls, adverse event notifications and general educational material about the safety of therapeutic goods.

The therapeutic goods information specified in Schedule 2 to the instrument is substantively the same as the information specified in the Former Specification, with drafting updates having been made principally to improve clarity and readability. Importantly, like the Former Specification, the therapeutic goods information specified in Schedule 2 to the Instrument encompasses information relating not only to samples of therapeutic goods that are tested under Part 5 of the TG Regulations, but also to information relating to samples tested outside that Part. That is, the Secretary may release information of a kind specified in Schedule 2 regardless of whether the testing of the sample in question was conducted under Part 5 of the TG Regulations.

Consultation

The TGA undertook public consultation between June and September 2024 in relation to proposed amendments to Part 5 of the TG Regulations, in which it was noted that consideration would be given to permitting the release of an analyst’s certificate to persons under section 61 of the Act. The TGA received 34 responses to that consultation, including from sponsors, manufacturers industry organisations and peak and professional bodies.

A small number of respondents raised concerns about the proposal to release information in an analyst’s certificate under section 61 of the Act. In particular, two respondents were broadly concerned that the discretionary nature of such a power may result in situations where a sponsor is not provided with a copy of an analyst’s certificate relating to the testing of their goods, meaning that the sponsor may have little to no visibility of the samples tested or the tests that were performed on those samples.

However, as outlined above, the discretionary nature of the power to release information in an analyst’s certificate to the specified persons, bodies or authorities reflects that, in some cases, it may not be appropriate to release such information. For example, where the release of the information may impact the investigation of non-compliance with the therapeutic goods regulatory framework. Further, the TGA may not always know, or be able to readily ascertain, the identity of the specified persons, bodies or authorities.

Schedule 2 to the Instrument replaces the Former Specification without substantively changing the effect of the Former Specification and Schedule 2 is consistent with the TGA’s existing practices and procedures concerning the publication of therapeutic goods information relating to the testing of therapeutic goods under subsection 61(5C). As such, no consultation was undertaken in relation to the Schedule 2 to the Instrument, or the repeal of the Former Specification.

Details of the Instrument are set out in Attachment A.

The Instrument is compatible with human rights and freedoms recognised or declared under section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011. A full statement of compatibility is set out in Attachment B.

The Instrument is a disallowable legislative instrument for the purposes of the Legislation Act 2003 and commences on 1 October 2025.

Attachment A

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

Section 1 – Name

This section provides that the name of the instrument is the Therapeutic Goods (Information Specification—Testing of Goods) Instrument 2025 (“the Instrument”).

Section 2 – Commencement

This section provides that the Instrument commences on 1 October 2025.

Section 3 – Authority

This section provides that the Instrument is made under subsections 61(5AB) and 61(5D) of the Therapeutic Goods Act 1989 (“the Act”).

Section 4 – Interpretation

Subsection 4(1) provides definitions for a number of terms used in the Instrument. These terms include, among others, ‘analyst’, ‘analyst’s certificate’, ‘instructions for use’ and ‘therapeutic goods information’.

Subsection 4(2) provides that a reference in the Instrument to a sample includes a reference to a part of a sample.

Subsection 4(3) provides that, for the avoidance of doubt, a reference in the Instrument to a sample includes a sample accessed, taken, collected, received or otherwise obtained:

under the Act; or
under regulations made under the Act, including the Therapeutic Goods Regulations 1990 (“the TG Regulations”) and Therapeutic Goods (Medical Devices) Regulations 2002 (“the MD Regulations”); or
by, or at the request or on the instruction of, a Commonwealth officer (including in the exercise of the executive power of the Commonwealth).

This would include, for example, samples that are:

 delivered by a person in relation to whom the goods are entered in the Australian Register of Therapeutic Goods (“the Register”), in compliance with a condition in paragraph 28(5)(h), subsection 32EA(2) or subsection 41FN(2) of the Act;

 taken by an authorised person from the premises of:

 a manufacturer who holds a licence issued under Part 3-3 of the Act, in accordance with the condition mentioned in paragraph 40(4)(b)(ii) of the Act;

 a manufacturer of a medical device in respect of whom a conformity assessment certificate has been issued—which the manufacturer must allow, in compliance with a condition imposed by the Act in respect of that certificate;

 a sponsor of a therapeutic good—which the sponsor must allow, in compliance with a condition imposed by the Act in respect of the registration, listing, or inclusion of the therapeutic good in the Register;

 delivered by a person seeking the registration, listing, or inclusion of a therapeutic good in the Register, as required by the Act, and in a manner approved by the Secretary;

 obtained by persons other than Therapeutic Goods Administration (“TGA”) officers who may be required to exercise powers or functions under the Act or regulations made under the Act (including, for example, Australian Border Force officers);

 taken or obtained by another entity (e.g., a regulator, health or law enforcement agency, or other authority) through the exercise of powers under their own legislation, which are then provided to the TGA for testing;

 purchased from an online or physical retailer;

 collected from the National Medical Stockpile;

 obtained from a state or territory health authority, where the authority requests that the TGA test the sample; or

 obtained from a user or consumer of a therapeutic good, where the user or consumer complains to the TGA about the safety or quality of a good and voluntarily sends a sample of the good the subject of their complaint to the TGA for testing.

Subsection 4(4) provides that, for the avoidance of doubt, a reference in the Instrument to testing of a sample includes testing conducted, being conducted or to be conducted (as relevant):

under the Act; or
under regulations made under the Act, including the TG Regulations and MD Regulations; or
by, or at the request or on the instruction of, a Commonwealth officer (including in the exercise of the executive power of the Commonwealth).

This is intended to include testing conducted under Part 5 of the TG Regulations, testing conducted under another provision of the Act, the TG Regulations or the MD Regulations, or testing conducted not under a provision of the Act, the TG Regulations or the MD Regulations (for example, if a TGA officer tests a sample outside of Part 5, such as under the executive capacity of the Commonwealth).

The note to this section also makes it clear that a number of expressions used in the Instrument have the same meaning as in the Act. These include ‘Commonwealth officer’, ‘directions for use’, ‘essential principles’, ‘included in the Register’, ‘manufacturer’, ‘presentation’, ‘product information’, ‘Register’, ‘Secretary’, ‘sponsor’, ‘supply’ and ‘therapeutic goods’.

Section 5 – Release of therapeutic goods information

This section provides that, for the purpose of subsection 61(5AA) of the Act, in relation to each item in the table in Schedule 1, the kinds of therapeutic goods information specified in column 2 may be released to a person, body or authority (or kinds of persons, bodies or authorities) specified in column 3, for the purposes specified in column 4.

This section also provides that, for the purposes of subsection 61(5C) of the Act, the kinds of therapeutic goods information specified in column 2 of the table in Schedule 2 may be released to the public.

Section 6 – Repeals

This section provides that each instrument specified in Schedule 3 is repealed as set out in the applicable items in that Schedule.

Schedule 1 – Release of therapeutic goods information to persons, bodies or authorities

This Schedule specifies the kinds of therapeutic goods information, the persons, bodies or authorities (or kinds of persons, bodies or authorities), and the purposes for which the information may be released under subsection 61(5AA) of the Act.

Item 1 of the table in Schedule 1 specifies the following:

in column 2, as the therapeutic goods information that may be released by the Secretary—information in an analyst’s certificate issued under subregulation 26(1) of the TG Regulations, including a copy of the certificate itself;

in column 3, as the persons, bodies or authorities to which the information in the analyst’s certificate may be released—any the following:

 the sponsor of the goods tested;

 the person from whom the sample tested was taken, collected, received or otherwise obtained;

 the person from whom access to the sample was obtained for the purpose of testing;

in column 4, as the purpose for which the information in the analyst’s certificate may be released to the specified persons, bodies or authorities—to inform one or more of those persons, bodies or authorities of the testing conducted on the sample, the results of that testing, or any other information included in the analyst’s certificate.

This item supports the release of information in an analyst’s certificate to the specified persons, where appropriate and where those specified persons can be identified (noting that it may not always be possible to identify who imported, exported, manufactured or supplied therapeutic goods).

In limited circumstances, the information in an analyst’s certificate may include personal information. Such information would possibly include:

the name of the person in relation to whom the goods tested are registered, listed or included in the Register, or the sponsor, manufacturer or supplier of the goods, where that person is an individual; and
the trade name of the goods tested, where this includes the name of an individual (noting that trade names infrequently contain the names, or parts of the names, of sponsors and manufacturers).

Use and disclosure of such information in accordance with the Instrument would be consistent with the Department’s obligations under the Privacy Act 1988 (“the Privacy Act”). It would only be in very limited circumstances, for example, the name of a supplier of goods who is an individual, or the name of a sponsor or manufacturer of goods that are not entered in the Register if they are an individual. In both these cases, the names may otherwise be publicly available.

The TGA, as part of the Department of Health, Disability and Ageing, is an APP entity for the purposes of the Privacy Act. Any use or disclosure of personal information in accordance with this Instrument would be consistent with the Privacy Act. The collection and use of the information specified in the Instrument, and its disclosure, is critical to providing transparency in relation to the TGA’s testing activities, and to communicating matters concerning the quality, safety and efficacy or performance of therapeutic goods tested with the public.

Schedule 2 – Therapeutic goods information for release to the public

This Schedule specifies the kinds of therapeutic goods information that may be released to the public under subsection 61(5C) of the Act.

Item 1 of the table in Schedule 2 specifies information relating to a sample tested, being tested, or that is intended to be tested (as relevant), including but not limited to the following:

information about the goods, which could include information:

 that describes or identifies the goods—such as trade name, model, indications or intended purpose of the goods, and, if the goods are in the Register, the registration number, listing number, biological number or device number of the goods;

 about the nature, presentation or characteristics of the goods—such as the type of goods (e.g., medicine, biological or medical device), the group, class, kind or classification of the goods, and the strength, size, formulation, composition, design or labelling of the goods; and

 about any ingredient or component that is, or is purported to have been, used in the manufacture of the goods—such as information about the nature or characteristics of, or risk of harm posed by, such ingredients or components;

information about the sample, which could include:

 the condition or state of the sample—such as information about any damage to the sample, and whether that damage is likely to affect, or has affected, the integrity of the sample;

 a description of the sample—such as the physical appearance (including of the labelling or packaging) of the sample, and, if applicable, a description of how the sample functions or operates;

 the date of manufacture or expiry of the sample; and

 the batch number or lot number of the sample;

information about how the sample was obtained, accessed or received by, or given to, the Department or person conducting the testing, including, for example, whether the sample was:

 taken or tested by authorised persons or authorised officers under the Act, TG Regulations or MD Regulations—including, for example, under the entry, search and warrant powers in Part 6-2 of the Act;

 provided by the person in relation to whom the therapeutic goods are entered in the Register, in compliance with a condition of the entry of the goods in the Register pursuant to paragraph 28(5)(a), paragraph 32EA(1)(a) or paragraph 41FN(1)(a) of the Act;

 provided by a member of the public or another government department or authority (e.g., the Australian Border Force); or

 purchased by departmental officers, or voluntarily submitted to departmental officers, by the retailer of the goods;

information about the sponsor, the manufacturer or the supplier of the goods, and (if applicable) the person in relation to whom the goods are registered, listed or included in the Register;
product information, instructions for use, directions for use, operational manuals, advertising material and packaging information, and information contained in any of these documents;
information held by the Department in relation to the manufacture or supply of the goods, including in relation to the quality, safety, efficacy or performance of the goods or the sample.

Item 2 of the table in Schedule 2 specifies information relating to the testing of a sample, including but not limited to the following:

 the reason(s) for testing the sample—such as whether the testing is for the purpose of programmed (i.e., routine) compliance monitoring, or in response to a safety or quality signal (e.g., a complaint, adverse event report, or other issue identified by the TGA);

 the name and description of the tests—such as information relating to:

 the scope of the tests—including, for example, a description of the part(s) of the sample tested; a description of a particular sub-type of testing that was conducted on the sample (such as a variant of a particular test method); the standards against which the testing was done (such as an ASTM or ISO standard); or the sampling plan applied to the testing; or

 any applicable standards (for medicines or other therapeutic goods regulated under Chapter 3 of the Act), or essential principles (for medical devices regulated under Chapter 4 of the Act), that are relevant to the testing;

 information about when, where and by whom the testing was conducted—such as whether the testing was conducted by an analyst or other APS employee in the Department, or by another appropriate person or body (including as arranged by an analyst under subregulation 25(2) of the TG Regulations);

 the results of the testing—such as whether or not the goods were found to comply with any applicable standards or the essential principles;

 the outcome of the testing—such as further testing that is required, any decision or action taken under the Act, TG Regulations or MD Regulations, and any action taken by the sponsor or manufacturer of the goods (such as in house testing following the TGA’s testing), or a Commonwealth officer or State or Territory officer, based on the results of the testing.

In limited circumstances, information of a kind specified in this Schedule may include personal information. Such information would possibly include:

the name of the person in relation to whom the goods tested are registered, listed or included in the Register, or the sponsor, manufacturer or supplier of the goods, where that person is an individual; and
the trade name of the goods tested, where this includes the name of an individual (noting that trade names infrequently contain the names, or parts of the names, of sponsors and manufacturers).

Use and disclosure of information in accordance with the Instrument would be consistent with the Department’s obligations under the Privacy Act, as outlined above.

Schedule 3 – Repeals

This Schedule repeals the Therapeutic Goods Information (Laboratory Testing) Specification 2017.

Attachment B

Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

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

This disallowable legislative instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

Overview of the Legislative Instrument

The Therapeutic Goods (Information Specification—Testing of Goods) Instrument 2025 (“the Instrument”) is a legislative instrument made under subsections 61(5AB) and 61(5D) of the Therapeutic Goods Act 1989 (“the Act”). It specifies, for the purpose of subsections 61(5AA) and (5C) of the Act respectively:

the kinds of therapeutic goods information that the Secretary may release to specified persons, bodies or authorities, and the purposes for which the Secretary may do so; and
the kinds of therapeutic goods information that the Secretary may release to the public.

the sponsor of the goods tested;
the person from whom the sample tested was taken, collected, received or otherwise obtained;
the person from whom access to the sample was obtained for the purpose of testing.

Background

TGA’s testing program

the pre-market assessment of therapeutic goods for registration, listing or inclusion in the Australian Register of Therapeutic Goods (“the Register”), and batch release of vaccines for release for supply in Australia;
post-market monitoring of therapeutic goods, regardless of whether those goods are in the Register or supplied subject to a relevant exemption, approval or authority—including, for example, compliance testing to ensure that such goods comply with applicable standards or the essential principles;
the investigation of suspected offences against or contraventions of the Act or its regulations—including, for example, to determine whether goods are counterfeit therapeutic goods, or a person has unlawfully supplied therapeutic goods that do not comply with applicable standards; and
regulatory decision-making—including, for example, to assist the Secretary in deciding whether or not to suspend or cancel the registration, listing or inclusion of therapeutic goods in the Register, or to require therapeutic goods to be recalled.

Testing under Part 5 of the Therapeutic Goods Regulations 1990

Testing may also be conducted outside Part 5 of the Therapeutic Goods Regulations 1990

testing under that regulation is inappropriate because extraordinary, urgent testing is needed to be done by (or as arranged by) the TGA to address a public health emergency;
the TGA intends to test a sample of goods for a purpose that does not relate to the administration of the legislative framework (including, for instance, testing the TGA performs solely for the purpose of assisting a Commonwealth, state or territory agency in the administration of their own legislation).

Purpose

the sponsor of the goods tested;
the person from whom the sample tested was taken, collected, received or otherwise obtained;
the person from whom access to the sample was obtained for the purpose of testing.

Human rights implications

The Instrument engages the right to health in Article 12 of the International Covenant on Economic, Social and Cultural Rights (“the ICESCR”) and the right to protection against arbitrary and unlawful interferences with privacy in Article 17 of the International Covenant on Civil and Political Rights (“the ICCPR”).

Right to Health

Article 12 of the ICESCR promotes the right of all individuals to enjoy the highest attainable standard of physical and mental health and includes an obligation to take reasonable measures within available resources to progressively secure broader enjoyment of the right.

In General Comment No. 14: The Right to the Highest Attainable Standard of Health (Art. 12) (2000), the United Nations Committee on Economic, Social and Cultural Rights states that health is a ‘fundamental human right indispensable for the exercise of other human rights’, and that the right to health is not to be understood as the right to be healthy, but includes the right to a system of health protection which provides equal opportunity for people to enjoy the highest attainable level of health.

The Instrument takes positive steps to promote the right to health by facilitating transparency and public awareness in relation to the testing activities of the TGA. It does so by enabling the Secretary to release information relating to the testing of a sample of therapeutic goods to specified persons, bodies or authorities for the purpose (broadly) of informing them of the results of the testing. This may be appropriate as the specified persons, bodies or authorities may also have an interest in the results of the testing of a particular sample – particularly where the results of the testing indicate that the goods are unlawful, or that urgent action is required by one or more of the persons, bodies or authorities to resolve or mitigate a potential threat to public health or safety.

The Instrument also ensures that members of the public are able to access important information regarding the quality, safety and efficacy of therapeutic goods that are imported into, exported from, or manufactured or supplied in, Australia. By enabling the Secretary to release the kinds of therapeutic goods information specified in Schedule 2, the Instrument promotes consumer confidence in the quality, safety and efficacy of therapeutic goods, and supports measures to encourage industry compliance with the legislative requirements for therapeutic goods that are imported into, exported from, or manufactured or supplied in Australia.

Right to protection against arbitrary and unlawful interferences with privacy

Article 17 of the ICCPR provides for the right of every person not to be subjected to arbitrary or unlawful interference with privacy. The prohibition on interference with privacy prohibits unlawful or arbitrary interferences with a person’s privacy, family, home and correspondence. It also prohibits unlawful attacks on a person’s reputation. Limitations on the right to privacy must be according to law and not arbitrary, meaning that limitations must be reasonable and necessary in the particular circumstances, as well as proportionate to the objectives the limitations seek to achieve.

In limited circumstances, the therapeutic goods information specified in the Instrument may include personal information. Such information would possibly include:

the name of the person in relation to whom the goods tested are registered, listed or included in the Register, or the sponsor, manufacturer or supplier of the goods (“the relevant person”), where that person is an individual; and
the trade name of the goods tested, where this includes the name of an individual (noting that trade names infrequently contain the names, or parts of the names, of sponsors and manufacturers).

In most instances, the relevant person is a company, meaning that the release of the information outlined above would not result in the release of personal information. In relation to goods registered, listed or included in the Register, the name of the sponsor and manufacturer of the goods are publicly searchable elements of the Register on the TGA’s website. Further, in cases where the goods tested are not registered, listed or included in the Register, the sponsor or trade name of the goods may already be publicly available on the label of the goods.

However, if none of these circumstances exist, the release of this information may result in the release of personal information that is not otherwise publicly available. This may include, for example, the name of a supplier of goods who is an individual, or the name of a sponsor or manufacturer of goods that are not entered in the Register if they are an individual.

The TGA, as part of the Department of Health, Disability and Ageing, is an APP entity for the purposes of the Privacy Act 1988 (“the Privacy Act”). Any use or disclosure of personal information in accordance with this Instrument would be consistent with the Privacy Act. The collection and use of the information specified in the Instrument, and its disclosure, is critical to providing transparency in relation to the TGA’s testing activities, and to communicating matters concerning the quality, safety and efficacy or performance of therapeutic goods tested with the public.

Importantly, the name of an individual would only be released to the public in accordance with this Instrument if it is necessary and proportionate to the objective of protecting or supporting public health and safety in Australia. As such, the disclosure of the information would not be an arbitrary or unlawful interference with a person’s privacy under Article 17 of the ICCPR, as the disclosure would be reasonable given it is appropriate and justified for the public to know the identity of the sponsor, manufacturer or supplier.

Conclusion

The Instrument is compatible with human rights because it promotes the right to health in Article 12 of the ICESCR and any engagement with the right to privacy in Article 17 of the ICCPR is reasonable, necessary and proportionate. The Instrument does not raise any other human rights issues.

Administered by Department of Health, Disability and Ageing

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