Therapeutic Goods (Listing) Notice 2014 (No. 4)

Administered by Department of Health, Disability and Ageing

Legislation au F2014L01275 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

THERAPEUTIC GOODS (LISTING) NOTICE 2014 (NO. 4)

Subsection 9A(5), Therapeutic Goods Act 1989

OUTLINE

Therapeutic Goods (Listing) Notice 2014 (No. 4) (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 ‘urea’ 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 ‘urea’ 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.

‘Urea’

Urea is a well-characterised, naturally occurring nitrogen metabolite that has widespread use in agriculture and cosmetics industries. It is present in humans, being a key end product of protein metabolism. It is secreted by the kidneys and is a major component of urine. Urea can also be produced synthetically.

In medicines in Australia, urea is currently used as an active ingredient in registered products, but is also used for non-medicinal roles in registered and listed products.

Primarily, urea may be used to hydrate and/or exfoliate skin, and soften nails. Therefore, medically it is mostly used in managing skin disorders such as psoriasis and dermatitis, and nail conditions. However, from the review of clinical studies it is recognised there is a potential for skin irritation when urea is present at concentrations at more than 10% when combined with some types of ingredients.

Noting this, the delegate of the Minister has determined that therapeutic goods containing ‘urea’ as a therapeutically active ingredient be included in the part of the Register for listed goods, when the preparations are for topical use only and contain no more than 10% (w/w) urea.

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 ‘urea’ 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 goods 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 2014 (No. 4) – ‘urea’

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. 4) (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 topical therapeutic goods containing ‘urea’ 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 2014 (No. 4) was enacted by the delegate of the Minister for Health under subsection 9A(5) of the Therapeutic Goods Act 1989. This notice was introduced to address the need for therapeutic goods containing 'urea' as a therapeutically active ingredient to be included in the Australian Register of Therapeutic Goods (the Register). Urea, while having therapeutic uses primarily in skin and nail care, can cause skin irritation at concentrations exceeding 10% when combined with certain ingredients. The notice mandates that such products be listed in the Register, rather than undergoing the more extensive registration process, provided they are for topical use and contain no more than 10% urea. This change aims to streamline the regulatory process for these products, reducing the burden on sponsors without compromising safety and quality. The Therapeutic Goods Administration (TGA) is responsible for overseeing the implementation of the Therapeutic Goods Act, which governs the quality, safety, and timely availability of therapeutic goods in Australia. The notice streamlines the regulatory process for topical therapeutic goods containing urea, allowing them to be listed in the Register rather than registered, provided the specified conditions are met. This legislative instrument was deemed to have low compliance costs and did not require extensive consultation. Furthermore, it was assessed as compatible with human rights, as it does not engage any of the applicable rights or freedoms outlined in the Human Rights (Parliamentary Scrutiny) Act 2011.

Scope and Application

The Therapeutic Goods (Listing) Notice 2014 (No. 4) is a notice made by the delegate of the Minister for Health under subsection 9A(5) of the Therapeutic Goods Act 1989, which mandates the inclusion of therapeutic goods containing 'urea' as a therapeutically active ingredient in the Australian Register of Therapeutic Goods (the Register) for listed goods. This applies to topical goods that contain no more than 10% (w/w) urea. The scope of this notice is national, as it applies across Australia under the national regulatory system for therapeutic goods overseen by the Therapeutic Goods Administration. The Notice facilitates sponsors in listing their products on the Register rather than registering them, which is a more rigorous and time-consuming process, thus offering a streamlined pathway for compliance. The notice does not involve new regulatory steps for industry but rather provides an alternative, less burdensome process for including certain therapeutic goods on the Register. This legislative instrument does not raise any human rights issues and 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.

Key Provisions

The Therapeutic Goods (Listing) Notice 2014 (No. 4) (the Listing Notice) was made under subsection 9A(5) of the Therapeutic Goods Act 1989 (the Act) and requires that therapeutic goods containing 'urea' as a therapeutically active ingredient, when used topically and containing no more than 10% urea, be included in the part of the Australian Register of Therapeutic Goods (the Register) for listed goods (section 1). This means that instead of undergoing a lengthy and costly registration process, sponsors can now apply to list these goods on the Register. This provision streamlines the process for listing specific therapeutic goods and facilitates their inclusion on the Register (section 2). Entities and parties subject to the Act must comply with the Listing Notice by ensuring that any therapeutic goods containing 'urea' for topical use and with a concentration of no more than 10% urea are listed on the Register. This involves adhering to the specific conditions set out in the Listing Notice and submitting the necessary applications and documentation to the Therapeutic Goods Administration (TGA) for listing approval (section 3). Compliance with this requirement ensures that these therapeutic goods meet the safety and quality standards set by the Act. The Act does not explicitly outline specific offences or penalties for non-compliance with the Listing Notice. However, general provisions within the Act may apply. Non-compliance with the Act's requirements could potentially result in civil or criminal penalties, depending on the nature and severity of the breach. For example, supplying therapeutic goods that do not comply with the Act could result in penalties under sections 86 to 88 of the Act, which may include fines of up to $222,200 for individuals and $1,111,000 for corporations, as well as potential criminal charges (section 4). The precise penalties would depend on the specific circumstances of the breach and any relevant provisions within the Act or other applicable legislation.

Area of Law: Medical Law
Instrument: Notice
Concepts: Definitions & Interpretation; Regulatory Standards; Licensing & Registration

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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