Therapeutic Goods (Information Specification—Testing of Goods) Instrument 2025
I, Lisa Kerr, as delegate of the Minister for Health and Ageing, make the following instrument.
Dated 25 September 2025
Lisa Kerr
Acting First Assistant Secretary Medical Devices and Product Quality Division Health Products Regulation Group Department of Health, Disability and Ageing
Contents
1 Name
2 Commencement
3 Authority
4 Definitions
5 Release of therapeutic goods information
6 Repeals
Schedule 1—Release of therapeutic goods information to persons, bodies or authorities
Schedule 2—Release of therapeutic goods information to the public
Schedule 3—Repeals
Therapeutic Goods Information (Laboratory Testing) Specification 2017
1 Name
This instrument is the Therapeutic Goods (Information Specification—Testing of Goods) Instrument 2025.
2 Commencement
(1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.
Commencement information
Column 1 Column 2 Column 3
Provisions Commencement Date/Details
The whole of this instrument 1 October 2025. 1 October 2025
Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.
(2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.
3 Authority
This instrument is made under subsections 61(5AB) and (5D) of the Therapeutic Goods Act 1989.
4 Definitions
Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:
(a) Commonwealth officer;
(b) directions for use;
(c) essential principles;
(d) included in the Register;
(e) manufacturer;
(f) presentation;
(g) product information;
(h) Register;
(i) Secretary;
(j) sponsor;
(k) supply;
(l) therapeutic goods.
(1) In this instrument:
Act means the Therapeutic Goods Act 1989.
analyst has the same meaning as in the TG Regulations.
analyst’s certificate means a certificate issued by an analyst under subregulation 26(1) of the TG Regulations.
instructions for use has the same meaning as in the MD Regulations.
MD Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002.
TG Regulations means the Therapeutic Goods Regulations 1990.
therapeutic goods information has the meaning given by subsection 61(1) of the Act.
(2) A reference in this instrument to a sample includes a reference to a part of a sample.
(3) For the avoidance of doubt, a reference in this instrument to a sample includes a sample accessed, taken, collected, received or otherwise obtained:
(a) under the Act; or
(b) under regulations made under the Act, including the TG Regulations and MD Regulations; or
(c) by, or at the request or on the instruction of, a Commonwealth officer (including in the exercise of the executive power of the Commonwealth).
(4) For the avoidance of doubt, a reference in this instrument to testing of a sample includes testing conducted, being conducted or to be conducted (as relevant):
(a) under the Act; or
(b) under regulations made under the Act, including the TG Regulations and MD Regulations; or
(c) by, or at the request or on the instruction of, a Commonwealth officer (including in the exercise of the executive power of the Commonwealth).
5 Release of therapeutic goods information
(1) 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.
Note: Under subsection 61(5AA) of the Act, the Secretary may release to a person, body or authority that is specified, or is of a kind specified, under subsection 61(5AB), specified kinds of therapeutic goods information for a specified purpose.
(2) For the purpose 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.
Note: Kinds of therapeutic goods information specified under subsection 61(5D) of the Act may be released by the Secretary to the public under subsection 61(5C).
6 Repeals
Each instrument that is 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
Note: See subsection 5(1).
Therapeutic goods information that may be released
Column 1 Column 2 Column 3 Column 4
Item Kinds of information Persons, bodies or authorities Purposes
1 information in an analyst’s certificate, including a copy of the certificate itself any of the following:(a) the sponsor of the goods tested;(b) the person from whom the sample tested was taken, collected, received or otherwise obtained;(c) the person from whom access to the sample was obtained for the purpose of testing to inform one or more of the persons, bodies or authorities in column 3 of the testing conducted on the sample, the results of that testing, or any other information included in the analyst’s certificate
Schedule 2—Release of therapeutic goods information to the public
Note: See subsection 5(2).
Therapeutic goods information that may be released to the public
Column 1 Column 2
Item Kinds of therapeutic goods information
1 information relating to a sample tested, being tested, or that is intended to be tested (as relevant), including but not limited to the following:(a) information about the goods, including:(i) information that describes or identifies the goods;(ii) information about the nature, presentation or characteristics of the goods; and(iii) information about any ingredient or component that was, or was purported to have been, used in the manufacture of the goods;(b) information about the sample, including:(i) the condition or state of the sample;(ii) a description of the sample;(iii) the date of manufacture or expiry of the sample; and(iv) the batch number or lot number of the sample;(c) information about how the sample was obtained, accessed or received by, or given to, the Department or person conducting the testing;(d) 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;(e) product information, instructions for use, directions for use, operational manuals, advertising material and packaging information, and information contained in any of these documents;(f) information relating to the manufacture or supply of the goods, including in relation to the quality, safety, efficacy or performance of the goods or the sample
2 information relating to the testing of a sample, including but not limited to the following:(a) the reason(s) for testing the sample;(b) the name and description of the test(s), information relating to the scope of the testing, and any applicable standards or essential principles relevant to the testing;(c) information about when, where and by whom the testing was conducted;(d) the results of the testing, including whether or not the goods were found to comply with any applicable standards or the essential principles;(e) the outcome of the testing, including:(i) further testing that is required;(ii) any decision or action taken under the Act, the TG Regulations or the MD Regulations; and(iii) any action taken by the sponsor or the manufacturer of the goods, or a Commonwealth officer
Schedule 3—Repeals
Note: See section 6.
Therapeutic Goods Information (Laboratory Testing) Specification 2017