Therapeutic Goods (Listing) Notice 2013 (No. 7)

Administered by Department of Health, Disability and Ageing

Legislation au F2013L02033 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

THERAPEUTIC GOODS (LISTING) NOTICE 2013 (NO. 7)

Subsection 9A(5), Therapeutic Goods Act 1989

OUTLINE

Therapeutic Goods (Listing) Notice 2013 (No. 7) (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 ‘alanylglutamine’ 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 refer). Medicines are either 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 ‘alanylglutamine’ 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 refers).

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.

‘Alanylglutamine’

‘Alanylglutamine’ (L-alanyl-L-glutamine) is a compound formed from two different amino acids. It comprises a single alanine molecule linked to a glutamine molecule and is produced via fermentation using a genetically manipulated organism, Escherichia coli strain K12.

Both ‘alanylglutamine’ and its two amino acid constituents are natural products of protein digestion in the human gastrointestinal tract. ‘Alanylglutamine’ itself does not have any metabolic or physiological activity - rather it is a compound delivering its constituent amino acids, which are common building blocks of proteins found in the human body.

In Australia, glutamine and alanine are currently permitted for use in listed medicines without any regulatory restrictions. ‘Alanylglutamine’ has a history of use in food and medicines without concern in jurisdictions such as the EU, Canada and the USA.

To that end, the delegate of the Minister has determined that therapeutic goods containing ‘alanylglutamine’ as a therapeutically active ingredient be included in the part of the Register for listed goods, when the preparations are for oral use only.

Draft Compositional Guidelines are prepared by the TGA and are intended to set out the standards and requirements for the specific forms or types of substances for use in listed medicines where there is no monograph in the British Pharmacopoeia, European Pharmacopoeia or the United States Pharmacopeia – National Formulary in relation to the ingredient or substance in question.

As it has been established that the substance is of appropriate quality to allow its use in listed medicines, the TGA has finalised a draft Compositional Guideline in relation to ‘alanylglutamine’, which will be available on the TGA’s Internet site (www.tga.gov.au) for consultation for six weeks following the registration of the Listing Notice on the FRLI. The Compositional Guideline will then be published on the TGA website in its final form.

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 effect of this Listing Notice is that sponsors wishing to use ‘alanylglutamine’ in the formulation of a medicine can list the medicine on the Register rather than registering that medicine. 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.

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).

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 2013 (No. 7) – ‘alanylglutamine’

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 2013 (No. 7) (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 ‘alanylglutamine’ 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 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 2013 (No. 7) was enacted by the delegate of the Minister for Health under subsection 9A(5) of the Therapeutic Goods Act 1989. This legislative instrument aims to address a gap in the national regulatory system concerning the listing of therapeutic goods containing 'alanylglutamine' as a therapeutically active ingredient. Prior to the enactment of this notice, such goods were not required to be included in the Australian Register of Therapeutic Goods for listed goods. The policy objective is to streamline the process for listing these goods, providing a more cost-effective and less time-consuming pathway compared to registration, while ensuring that the quality and safety of these products remain within acceptable standards. The Therapeutic Goods Administration, responsible for administering the Act, determined that 'alanylglutamine', a compound formed from two different amino acids, is of sufficiently low risk for inclusion in listed medicines. The notice mandates that therapeutic goods containing this ingredient, intended for oral use only, be listed in the Register, facilitating easier access to the Australian market. This approach leverages the existing compositional guidelines and evaluation processes to ensure the safety and quality of these products. The notice reflects a minor regulatory change with low compliance costs, designed to enhance the efficiency of the therapeutic goods market without compromising public health.

Scope and Application

The Therapeutic Goods (Listing) Notice 2013 (No. 7) is a regulatory notice made by the delegate of the Minister for Health under subsection 9A(5) of the Therapeutic Goods Act 1989. The Notice mandates that therapeutic goods containing 'alanylglutamine' as a therapeutically active ingredient be included in the part of the Australian Register of Therapeutic Goods (the Register) designated for listed goods, provided they are intended for oral use. This Notice applies to entities and individuals involved in the supply, importation, manufacture, or exportation of such therapeutic goods in Australia. It facilitates a more streamlined process for listing these goods on the Register rather than undergoing the more rigorous and time-consuming registration process, thereby easing the burden on sponsors. The Notice commenced on the day after it was registered on the Federal Register of Legislative Instruments. The scope of the Notice is limited to Australia, impacting entities and individuals within the Commonwealth. The Notice does not involve any new regulatory steps for industry but rather simplifies the pathway for listing specific therapeutic goods, significantly benefiting sponsors by reducing both cost and time. The Notice does not contain any specific exclusions or thresholds beyond the conditions that the therapeutic goods must contain 'alanylglutamine' and be for oral use. The application and effect of the Notice may be further defined through subsidiary instruments, such as the draft Compositional Guidelines prepared by the Therapeutic Goods Administration (TGA). These guidelines will detail the standards and requirements for the specific forms or types of 'alanylglutamine' substances to be used in listed medicines. While the Notice itself does not raise any human rights issues, a Statement of Compatibility has been provided, affirming its alignment with the human rights and freedoms recognised in international instruments.

Key Provisions

The Therapeutic Goods (Listing) Notice 2013 (No. 7) (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 requires therapeutic goods containing 'alanylglutamine' as a therapeutically active ingredient to be included in the Australian Register of Therapeutic Goods (the Register) for listed goods, subject to certain conditions (sections 1 and 2). The Listing Notice came into effect on the day after it was registered on the Federal Register of Legislative Instruments (section 2). The primary purpose of this notice is to facilitate easier access to the market for listed medicines containing 'alanylglutamine' by allowing sponsors to use the listing process, which is less costly and time-consuming than the registration process (section 1). The Act mandates that therapeutic goods be included on the Register before being supplied, imported, manufactured, or exported in Australia (sections 19B and 19D). The Therapeutic Goods Administration (TGA) administers the Act and is responsible for evaluating the safety and quality of therapeutic goods (section 1). The Listing Notice specifies that therapeutic goods containing 'alanylglutamine' must meet the standards and requirements set out in the draft Compositional Guideline, which will be available for consultation on the TGA website (section 1). The TGA will evaluate applications for listing based on safety and quality, ensuring that the ingredient or substance is of low risk and correctly characterised (section 1). The Listing Notice does not introduce new regulatory steps for industry but provides a streamlined pathway for products containing 'alanylglutamine' to be listed on the Register rather than registered (section 1). The Office of Best Practice Regulation has advised that a regulatory impact statement is not required for this notice, given its minor and machinery nature (section 1). The Statement of Compatibility confirms that the Listing Notice is compatible with human rights and does not raise any human rights issues (section 4).

Area of Law: Medical Law
Instrument: Notice
Concepts: Definitions & Interpretation; Regulatory Standards; Reporting & Disclosure Obligations

Interactions

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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