Therapeutic Goods (Standard for Tampons) (TGO 103) Order 2019

Administered by Department of Health, Disability and Ageing

Legislation au F2019L00428 In force Legislative Instrument

Legislation content

 

Therapeutic Goods (Standard for Tampons) (TGO 103) Order 2019

made under subsection 10(1) of the

Therapeutic Goods Act 1989

Compilation No. 1

Compilation date: 9 December 2022

Includes amendments up to: F2022L01598

About this compilation

This compilation

This is a compilation of the Therapeutic Goods (Standard for Tampons) (TGO 103) Order 2019 that shows the text of the law as amended and in force on 9 December 2022 (the compilation date).

The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.

Uncommenced amendments

The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Legislation Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the series page on the Legislation Register for the compiled law.

Application, saving and transitional provisions for provisions and amendments

If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.

Modifications

If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the series page on the Legislation Register for the compiled law.

Selfrepealing provisions

If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.

 

 

 

Contents

1  Name

3  Authority

4  Definitions

5  Standard

6  Requirements

6A  Transitional arrangements relating to the Therapeutic Goods (Standard for Tampons) (TGO 103) Amendment Order 2022

Endnotes

Endnote 1—About the endnotes

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history

1  Name

 (1) This instrument is the Therapeutic Goods (Standard for Tampons) (TGO 103) Order 2019.

 (2) This instrument may also be cited as TGO 103.

3  Authority

  This instrument is made under section 10 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) label;

(b) sponsor;

(c) therapeutic goods.

  In this instrument:

Act means the Therapeutic Goods Act 1989.

Australian Standard means the Australian Standard AS 2869:2022 Tampons-Menstrual published by, or on behalf of, Standards Australia, as in force or existing at 30 November 2022.

tampons means therapeutic goods that are menstrual tampons.

5  Standard

 This instrument constitutes a standard for tampons.

6  Requirements

 The requirements in relation to tampons are:

 (a) those requirements specified in the Australian Standard; and

(b) the requirement that the label of the tampons must include the name and address of the manufacturer or sponsor of the tampons.

6A  Transitional arrangements relating to the Therapeutic Goods (Standard for Tampons) (TGO 103) Amendment Order 2022

 (1) Despite the amendments made by the Amendment Order, the requirements relating to labelling that are specified in the old Standard may continue to be complied with, as an alternative to the requirements relating to labelling that are specified in the new Standard, for the duration of the transitional period.

 (2) In this section:

Amendment Order means the Therapeutic Goods (Standard for Tampons) (TGO 103) Amendment Order 2022.

new Standard means the Australian Standard AS 2869:2022 Tampons-Menstrual published by, or on behalf of, Standards Australia, as in force or existing at 30 November 2022.

old Standard means the Australian Standard AS 2869-2008 Tampons-Menstrual published by, or on behalf of, Standards Australia, as in force or existing at 31 March 2019.

transitional period means the period beginning on the commencement of the Amendment Order and ending on 31 December 2024.

Endnotes

Endnote 1—About the endnotes

The endnotes provide information about this compilation and the compiled law.

The following endnotes are included in every compilation:

Endnote 1—About the endnotes

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history

Abbreviation key—Endnote 2

The abbreviation key sets out abbreviations that may be used in the endnotes.

Legislation history and amendment history—Endnotes 3 and 4

Amending laws are annotated in the legislation history and amendment history.

The legislation history in endnote 3 provides information about each law that has amended (or will amend) the compiled law. The information includes commencement details for amending laws and details of any application, saving or transitional provisions that are not included in this compilation.

The amendment history in endnote 4 provides information about amendments at the provision (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with a provision of the law.

Misdescribed amendments

A misdescribed amendment is an amendment that does not accurately describe how an amendment is to be made. If, despite the misdescription, the amendment can be given effect as intended, then the misdescribed amendment can be incorporated through an editorial change made under section 15V of the Legislation Act 2003.

If a misdescribed amendment cannot be given effect as intended, the amendment is not incorporated and “(md not incorp)” is added to the amendment history.

 

Endnote 2—Abbreviation key

 

ad = added or inserted

orig = original

am = amended

par = paragraph(s)/subparagraph(s)

amdt = amendment

/subsubparagraph(s)

c = clause(s)

pres = present

C[x] = Compilation No. x

prev = previous

Ch = Chapter(s)

(prev…) = previously

def = definition(s)

Pt = Part(s)

Dict = Dictionary

r = regulation(s)/rule(s)

disallowed = disallowed by Parliament

reloc = relocated

Div = Division(s)

renum = renumbered

exp = expires/expired or ceases/ceased to have

rep = repealed

effect

rs = repealed and substituted

F = Federal Register of Legislation

s = section(s)/subsection(s)

gaz = gazette

Sch = Schedule(s)

LA = Legislation Act 2003

Sdiv = Subdivision(s)

LIA = Legislative Instruments Act 2003

SLI = Select Legislative Instrument

(md not incorp) = misdescribed amendment

SR = Statutory Rules

cannot be given effect

SubCh = SubChapter(s)

mod = modified/modification

SubPt = Subpart(s)

No. = Number(s)

underlining = whole or part not

o = order(s)

commenced or to be commenced

Ord = Ordinance

 

 

Endnote 3—Legislation history

 

Name

Registration

Commencement

Application, saving and transitional provisions

Therapeutic Goods (Standard for Tampons) (TGO 103) Order 2019

27 Mar 2019 (F2019L00428)

31 Mar 2019

Therapeutic Goods (Standard for Tampons) (TGO 103) Amendment Order 2022

8 Dec 2022 (F2022L01598)

9 Dec 2022

 

Endnote 4—Amendment history

 

Provision affected

How affected

s 2……………………………….

rep LA s 48D

s 4……………………………….

am F2022L01598

s 6A……………………………..

ad F2022L01598

s 7……………………………….

rep LA s 48C

Sch 1 ……………………………

rep LA s 48C

 

Overview

The Therapeutic Goods (Standard for Tampons) (TGO 103) Order 2019 was enacted to set a standard for tampons under the Therapeutic Goods Act 1989. This legislative instrument aims to ensure tampons meet specific health and safety standards, thereby protecting consumer health by mandating compliance with the Australian Standard AS 2869:2022 Tampons-Menstrual, including labelling requirements that specify the manufacturer or sponsor's name and address. This Order was made by the Therapeutic Goods Administration, an entity under the Australian Government's Department of Health and Aged Care, reflecting a policy objective to enhance the safety and quality of therapeutic goods available to consumers. The enactment of this Order addresses the need for updated regulatory standards to keep pace with advancements in product safety and manufacturing practices.

Scope and Application

The Therapeutic Goods (Standard for Tampons) (TGO 103) Order 2019 is made under the Therapeutic Goods Act 1989 and applies to tampons classified as therapeutic goods in Australia. This legislative instrument sets forth the standards and requirements that tampons must meet to be legally marketed and sold within the country. It mandates that tampons comply with the specific requirements outlined in the Australian Standard AS 2869:2022 Tampons-Menstrual, alongside the requirement that the label of the tampons must include the name and address of the manufacturer or sponsor. The Order also includes transitional arrangements that allow compliance with the older Australian Standard AS 2869-2008 Tampons-Menstrual during a transitional period ending on 31 December 2024. This ensures a smooth transition for manufacturers and sponsors adjusting to the updated standards. This Order applies across the Commonwealth of Australia, affecting manufacturers, sponsors, and entities involved in the production and distribution of tampons.

Key Provisions

The Therapeutic Goods (Standard for Tampons) (TGO 103) Order 2019 (sections 1-7) sets the standards for tampons as therapeutic goods in Australia, aligning with the Australian Standard AS 2869:2022 Tampons-Menstrual. The Order establishes that tampons must meet the requirements specified in this Australian Standard, as well as requiring that the label of the tampons includes the name and address of the manufacturer or sponsor (section 6). The Order also includes transitional arrangements to allow compliance with the old Standard during a specified period (section 6A). Entities involved in the manufacture, supply, or importation of tampons are obligated to ensure that their products comply with the standards outlined in the Australian Standard AS 2869:2022, including the labelling requirements specified in section 6. This involves adhering to the detailed technical specifications and quality controls set out in the Standard, and ensuring that the labels of the tampons include the necessary information about the manufacturer or sponsor. Failure to comply with the requirements set out in the Therapeutic Goods (Standard for Tampons) (TGO 103) Order 2019 can lead to various legal consequences. Under the Therapeutic Goods Act 1989, breaches may result in civil penalties, including fines up to a significant amount as stipulated by the Act. Additionally, serious non-compliance could also lead to criminal charges, with potential imprisonment for individuals responsible for the contravention. These penalties underscore the importance of adhering to the specified standards to ensure consumer safety and product quality.

Legal classification tags

Area of Law
Medical Law
Instrument
Legislative Instrument
Concepts
Definitions & Interpretation
Requirements
Transitional Provisions

Interactions

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.