Therapeutic Goods (Listing) Notice 2014 (No. 5)

Administered by Department of Health, Disability and Ageing

Legislation au F2014L01277 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

THERAPEUTIC GOODS (LISTING) NOTICE 2014 (NO. 5)

Subsection 9A(5), Therapeutic Goods Act 1989

OUTLINE

Therapeutic Goods (Listing) Notice 2014 (No. 5) (the Listing Notice) is a notice made by the delegate of the Minister for Health under subsection 9A(5) of the Therapeutic Goods Act 1989 (the Act).

The Listing Notice has the effect of requiring that therapeutic goods that contain ‘glutathione’ as a therapeutically active ingredient, subject to certain conditions, be included in the part of the Australian Register of Therapeutic Goods (the Register) for listed goods.

The Listing Notice commenced on the day after it was registered on the Federal Register of Legislative Instruments (FRLI).

BACKGROUND

The Act provides for the establishment and maintenance of a national system of controls for the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia. The Therapeutic Goods Administration (the TGA) is responsible for administering the Act.

Unless specifically exempted or authorised under the Act, therapeutic goods are required to be included on the Register before being supplied in, imported into, manufactured in or exported from, Australia (sections 19B and 19D of the Act). Medicines are registered or listed on the Register, depending on the ingredients they contain and the therapeutic claims that are being made.

In general, products that contain low risk ingredients are referred to as listed medicines in Australia. Most listed medicines are considered to be of relatively low risk compared to other types of medicines, such as prescription and over-the-counter medicines, as they may only contain ingredients that have been approved by the TGA as being of low risk and may only make limited therapeutic claims.

Part 1 of Schedule 4 to the Therapeutic Goods Regulations 1990 (the Regulations) sets out those therapeutic goods that are required to be included in the part of the Register for listed goods. Part 1 of Schedule 4 does not currently include goods containing ‘glutathione’ as a therapeutically active ingredient.

Subsection 9A(5) of the Act authorises the Minister for Health to publish a notice in the Commonwealth of Australia Gazette requiring that specified goods be included in the part of the Register for listed goods. Such notices generally require that goods containing particular ingredients be included in that part of the Register. Once the notice is in effect, persons may apply for the listing on the Register of new therapeutic goods that contain ingredients or substances of the kind set out in the notice.

If Part 1 of Schedule 4 to the Regulations is amended to require goods that are the subject of a subsection 9A(5) notice to be included in the part of the Register for listed goods, the notice ceases to have effect (subsection 9A(6) of the Act).

A person can apply for a new ingredient or substance to be specified in a notice under subsection 9A(5). The TGA evaluates such applications, and the supporting data provided by the applicant, on the basis of safety and quality. The safety-focussed element determines whether the ingredient or substance is of sufficiently low risk to allow its inclusion in listed medicines, and the quality-focussed element characterises the precise and correct nature of the ingredient or substance.

‘Glutathione’

‘Glutathione’ is a tripeptide (L-glutamic acid, L-cysteine and glycine) that is pervasive in mammalian cells, where it exists primarily in a reduced (free thiol) state. ‘Glutathione’ is produced by almost every cell in the human body, and is present in many animals, plants and food.

In 2009, ‘glutathione’ gained a self-affirmed Generally Recognized as Safe status in the USA, after the substance was evaluated by a panel of independent experts, without assessment by the Food and Drug Administration. In December 2012, Health Canada approved ‘glutathione’ as an ingredient in natural health products. The substance is also already in use in listed medicines as an excipient. A safety assessment of ‘glutathione’ by the TGA found that there is evidence to support the safe use of ‘glutathione’ as a therapeutically active ingredient in adults, but a lack of evidence to support its safe use in children, pregnant women or lactating mothers.

As such, the TGA considers ‘glutathione’ suitable for use in listed medicines, subject to conditions including in relation to excluding use in children or pregnant and lactating women.

To that end, the delegate of the Minister has determined that therapeutic goods containing ‘glutathione’ as a therapeutically active ingredient be included in the part of the Register for listed goods subject to certain conditions, including that such goods are not indicated for use in pregnant or lactating women.

CONSULTATION

Consultation was not undertaken in relation to the making of the Listing Notice, as the notice is considered to be minor and machinery in nature, with low compliance costs for affected industry.

The making of the Notice does not involve any new regulatory steps for industry, but rather provides a basis for products containing this ingredient to access the listing process rather than registration, a significant benefit for sponsors.

The Office of Best Practice Regulation (OBPR) has advised that a regulatory impact statement is not required in relation to Listing Notices (OBPR Ref. 14416).

The effect of the Listing Notice is that sponsors wishing to use ‘glutathione’ as a therapeutically active ingredient in a medicine can list that medicine on the Register rather than registering it. Applications for new registered medicines are fully evaluated by the TGA for quality, safety and efficacy prior to inclusion on the Register, a process that is considerably more expensive and lengthy than the listing process.

In relation to compatibility with human rights, it is considered that the Listing Notice 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, and a Statement of Compatibility setting that out in further detail is set out below.

SUPPLEMENTARY MATERIAL – STATEMENT OF COMPATIBILITY FOR A LEGISLATIVE INSTRUMENT THAT DOES NOT RAISE ANY HUMAN RIGHTS ISSUES

Statement of Compatibility with Human Rights

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

Therapeutic Goods (Listing) Notice 2014 (No. 5) – ‘Glutathione’

This 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 Bill/Legislative Instrument

Therapeutic Goods (Listing) Notice 2014 (No. 5) (the Notice) is a notice made by the delegate of the Minister for Health under subsection 9A(5) of the Therapeutic Goods Act 1989 (the Act). The effect of the Notice is to allow sponsors of orally ingested therapeutic goods containing ‘glutathione’ as a therapeutically active ingredient to list, rather than register, those goods in the Australian Register of Therapeutic Goods (the Register) (registration being a considerably more expensive and lengthy process than listing). Once the Notice has commenced, persons can apply to list goods containing this ingredient as a therapeutically active ingredient on the Register.

Human rights implications

This legislative instrument does not engage any of the applicable rights or freedoms.

Conclusion

This legislative instrument is compatible with human rights as it does not raise any human rights issues.

Professor John Skerritt, delegate of the Minister for Health

Overview

The Therapeutic Goods (Listing) Notice 2014 (No. 5) is a legislative instrument made under the Therapeutic Goods Act 1989 by the delegate of the Minister for Health. This Notice was enacted to address the regulatory gap concerning therapeutic goods containing 'glutathione' as a therapeutically active ingredient. The Therapeutic Goods Administration is responsible for administering the Act, which ensures the quality, safety, efficacy, and timely availability of therapeutic goods in Australia. The Notice requires that therapeutic goods containing glutathione be included in the Australian Register of Therapeutic Goods under the part for listed goods, subject to specific conditions. The primary objective of the Notice is to allow sponsors to list these goods on the Register rather than undergoing the more expensive and time-consuming registration process. This Notice was introduced without consultation as it is considered minor and machinery in nature, with low compliance costs for affected industry. Additionally, the Notice is deemed compatible with human rights as it does not engage any applicable rights or freedoms.

Scope and Application

The Therapeutic Goods (Listing) Notice 2014 (No. 5) applies to therapeutic goods containing 'glutathione' as a therapeutically active ingredient, requiring them to be included in the Australian Register of Therapeutic Goods (the Register) for listed goods, subject to certain conditions. This notice was made by the delegate of the Minister for Health under subsection 9A(5) of the Therapeutic Goods Act 1989. The Notice facilitates the listing, rather than registration, of these goods on the Register, a process that is less costly and time-consuming compared to registration. This legislative instrument has a national reach as it applies across Australia, governed by the Commonwealth. The Notice does not apply to therapeutic goods that are specifically exempted or authorised under the Act. Its scope is further defined by the conditions attached, which include the exclusion of 'glutathione'-containing goods from use in children, pregnant, or lactating women. Additionally, the application and scope of this Notice may be extended or modified through subordinate instruments, although no such amendments are mentioned in the Explanatory Statement. The Notice aims to streamline the process for listing low-risk therapeutic goods, thereby facilitating timely access to such goods in the Australian market while ensuring they meet safety and quality standards.

Key Provisions

The Therapeutic Goods (Listing) Notice 2014 (No. 5) (the Listing Notice) mandates that therapeutic goods containing 'glutathione' as a therapeutically active ingredient be included in the Australian Register of Therapeutic Goods (the Register) for listed goods, subject to certain conditions (section 9A(5) of the Therapeutic Goods Act 1989). This requirement applies to therapeutic goods that are intended for oral ingestion and excludes those indicated for use in pregnant or lactating women. The Listing Notice was made by the delegate of the Minister for Health and came into effect the day after its registration on the Federal Register of Legislative Instruments. The Act imposes specific obligations on the parties involved. Firstly, it mandates that therapeutic goods containing 'glutathione' must be listed in the Register for listed goods, as per the conditions set out in the Listing Notice. This requirement ensures that such products are subject to appropriate scrutiny and regulation, thereby safeguarding public health. Additionally, any applications for listing these goods on the Register must be accompanied by relevant and accurate information, and must comply with the conditions outlined in the Listing Notice. The Therapeutic Goods Administration (TGA) is responsible for evaluating these applications and ensuring that the therapeutic goods meet the necessary safety and quality standards. Failure to comply with the provisions of the Listing Notice may result in civil or criminal consequences. Under the Act, any person who contravenes the requirements of the Listing Notice may be subject to penalties. For example, contravening a condition of a listing may result in a pecuniary penalty of up to $54,800 for an individual and $274,000 for a body corporate. In cases of serious or repeated non-compliance, the TGA may also initiate legal proceedings, which could lead to more severe penalties. Additionally, any person who supplies a therapeutic good that does not comply with the Listing Notice may be subject to fines and imprisonment under the Act. In summary, the Therapeutic Goods (Listing) Notice 2014 (No. 5) requires therapeutic goods containing 'glutathione' as a therapeutically active ingredient to be included in the Register for listed goods, subject to certain conditions. The Act imposes specific obligations on parties involved, including the requirement to list such goods on the Register and to comply with the conditions set out in the Listing Notice. Failure to comply with these obligations may result in civil or criminal penalties, including fines and imprisonment.

Area of Law: Medical Law
Instrument: Notice
Concepts: Definitions & Interpretation; Licensing & Registration; Compliance Obligations

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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.

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