Therapeutic Goods Information (Laboratory Testing) Amendment Instrument 2023

I, Tracey Duffy, as delegate of the Minister for Health and Aged Care, make the following instrument.

Dated 8 November 2023

Tracey Duffy

First Assistant Secretary
Health Products Regulation Group
Department of Health and Aged Care

Contents

1 Name

2 Commencement

3 Authority

4 Schedules

Schedule 1—Amendments

Therapeutic Goods Information (Laboratory Testing) Specification 2017

1  Name

  This instrument is the Therapeutic Goods Information (Laboratory Testing) Amendment Instrument 2023.

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.

Note: This table relates only to the provisions of this instrument as originally made.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 subsection 61(5D) of 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  Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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

Therapeutic Goods Information (Laboratory Testing) Specification 2017

1  Section 4

Before “In this specification:”, insert “(1)”.

2  Section 4 (at the end of the definition of sample)

Add:

Note: See also subsection (2).

3  Section 4 (after paragraph (a) of the note)

Insert:

(aa) Commonwealth officer;

4  At the end of section 4

Add:

 (2) For the avoidance of doubt, a reference in this instrument to a sample includes a sample (or part of a sample) taken, collected or otherwise obtained:

 (a) under the Act; or

 (b) under regulations made under the Act (including the Therapeutic Goods Regulations 1990); 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).

 (3) For the avoidance of doubt, a reference in this instrument to a test includes a test, analysis or examination conducted or otherwise carried out:

 (a) under the Act; or

 (b) under regulations made under the Act (including the Therapeutic Goods Regulations 1990); 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).