This instrument is the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.

(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
1. 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Note: This table relates only to the provisions of this instrument as originally made.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 the Therapeutic Goods Act 1989.

4 Schedules

Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1—Amendments relating to testing of goods

Part 1—Amendments

Therapeutic Goods Regulations 1990

1 Regulation 2 (definition of analysis)

Repeal the definition.

2 Regulation 2

Insert:

analyst: see subregulation 24(1).

3 Regulation 2 (definition of sample)

Repeal the definition.

4 Subparagraph 20(b)(iv)

Omit “control;”, substitute “control.”.

5 Paragraph 20(c)

Repeal the paragraph.

6 Part 5

Repeal the Part, substitute:

Part 5—Testing of goods

23 Purpose of this Part

(1) This Part is made for the purposes of subsection 63(1) and paragraphs 63(2)(d) and (g) of the Act.

(2) This Part does not preclude the testing of goods other than under this Part.

24 Nomination of analysts

(1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.

(2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.

25 Testing of samples of goods

(1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:

(a) ascertaining whether or not the goods are therapeutic goods or vaping goods;

(b) assessing the quality, safety, efficacy or performance of therapeutic goods or vaping goods;

(c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;

(d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.

(2) If an analyst selects a sample of goods for testing under this regulation, the analyst must:

(a) test the sample or arrange for another analyst to test the sample; or

(b) arrange for the sample to be tested by another appropriate person or body.

Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.

(3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:

(a) the sample is not required to be tested under this regulation; and

(b) if testing of the sample has already commenced—the testing may be ceased.

(4) A sample of goods may be tested under this regulation:

(a) regardless of how or where the sample was obtained or accessed by, or given to:

(i) the Department or an analyst; or

(ii) another person or body as arranged under paragraph (2)(b); and

(b) whether or not the goods are registered, listed or included in the Register.

(5) To avoid doubt:

(a) more than one test may be conducted on a particular sample of goods; and

(b) more than one analyst or other person or body may test a particular sample of goods; and

(6) A reference in this regulation to a sample of goods includes a reference to a part of a sample of goods.

26 Certificate of analyst

Analyst to issue certificate

(1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:

(a) the test that was conducted; and

(b) the results of the testing.

(2) The certificate may also set out other information relating to the sample or the testing of the sample.

(3) The certificate may cover:

(a) more than one test conducted on the sample; and

(b) tests conducted on the sample by different analysts or other persons or bodies; and

(4) More than one certificate may be issued under subregulation (1) in relation to a particular sample.

Providing certificate to certain persons

(5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.

Use of certificate in proceedings

(6) In:

(a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or

(b) any other proceedings under the Act or regulations made under the Act;

a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.

Document purporting to be certificate

(7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.

References to a sample of goods

(8) A reference in this regulation to a sample of goods includes a reference to a part of a sample of goods.

7 Regulation 44

Omit “analyse”, substitute “test”.

8 Regulation 44

Omit “analysis”, substitute “testing”.

9 Regulation 46B

Repeal the regulation, substitute:

46B Protected persons

Immunity from civil actions

(1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:

(a) an analyst;

(b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);

(c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.

Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.

Protection from criminal responsibility

(2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:

(a) a person to whom powers or functions are delegated under subsection 57(1A) of the Act;

(b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);

(c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;

(d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.

Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.

10 Subdivision D of Division 12 of Part 9

Repeal the Subdivision.

11 Regulation 101

Repeal the regulation.

12 Schedule 5 (table item 3, column 2, paragraph (d))

Omit “analysis or”.

13 Schedule 5A (table item 4, column 3, subparagraph (g)(iv))

Omit “or a person who is an authorised officer for the purposes of a provision of Part 5 of these Regulations”.

14 Schedule 5A (table item 8, column 3, subparagraph (f)(iv))

Omit “or a person who is an authorised officer for a provision of Part 5 of these Regulations”.

15 Schedule 5A (table item 10, column 3, subparagraph (h)(iv))

Omit “or a person who is an authorised officer for the purposes of a provision of Part 5 of these Regulations.”.

16 Schedule 5A (table item 11, column 3, subparagraph (g)(iv))

Omit “or a person who is an authorised officer for the purposes of a provision of Part 5 of these Regulations.”.

17 Schedule 5A (table item 12, column 3, subparagraph (g)(iv))

Omit “or a person who is an authorised officer for the purposes of a provision of Part 5 of these Regulations.”.

Part 2—Application, transitional and saving provisions

Therapeutic Goods Regulations 1990

18 In the appropriate position in Part 9

Insert:

Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025

112 Definitions

In this Division:

amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.

commencement day means the day this Division commences.

113 Sampling and testing

(1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:

(a) taken before the commencement day under paragraph 24(1)(c) as in force immediately before the commencement day; or

(b) delivered before the commencement day under paragraph 28(5)(h) or subsection 41FN(2) of the Act;

as if the repeal had not occurred.

(2) Despite the repeal of regulations 29 and 30 by the amending regulations:

(a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and

(b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;

as if the repeal had not occurred.

(3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.

(4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:

(a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and

(b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.

(5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.

114 Protected persons

The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.

Schedule 2—Other amendments

Therapeutic Goods (Medical Devices) Regulations 2002

1 Subregulations 11.54(2) and (6)

Omit “26 May 2026”, substitute “31 December 2028”.

Therapeutic Goods Regulations 1990

2 Regulation 2 (definition of mercury‑added products)

Omit “Part 1”, substitute “Part I”.