Therapeutic Goods (Listing) Notice 2015 (No. 1)

Administered by Department of Health, Disability and Ageing

Legislation au F2015L00119 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

THERAPEUTIC GOODS (LISTING) NOTICE 2015 (NO. 1)

Subsection 9A(5), Therapeutic Goods Act 1989

OUTLINE

Therapeutic Goods (Listing) Notice 2015 (No. 1) (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 revoking Therapeutic Goods (Listing) Notice 2012 (No.3 ) and requiring that therapeutic goods that contain ‘Ubiquinol-10’ 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 ‘Ubiquinol-10’ 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 changes to certain conditions associated with an ingredient specified in a notice under subsection 9A(5). The TGA evaluates such applications, 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.

‘UBIQUINOL-10’

Ubiquinol-10 is the reduced form of what is commonly known as 'coenzyme Q10' (CoQ10). In the mammalian body, including in humans, CoQ10 is a key component for energy production in all cells and also has other functions, including antioxidant properties. It is synthesised by the body and may be obtained through the diet, mainly through foods such as meat, poultry and fish.

Both the fully reduced (ubiquinol-10) and the fully oxidised (ubidecarenone/ ubiquinone-10) forms of CoQ10 exist in the body, where they are fully convertible. Ubiquinol-10 is the dominant form of CoQ10 found in the healthy human body.

In Australia, Therapeutic Goods (Listing) Notice 2012 (No. 3) permitted the use of ubiquinol-10 as an active ingredient in listed medicines for oral use subject to certain conditions, including that the maximum daily dose be restricted to 150 mg, and that a label advisory statement is required to warn against potential interaction with warfarin containing medicines.

In 2014, the TGA further considered the available information relating to ubiquinol-10, and an up-to-date safety risk assessment for ubiquinol-10 concluded that a maximum daily dose of 300 mg be of sufficiently low risk for use in listed medicines. The risk assessment also concluded that there is no impediment to the approval of combined use of ubiquinol-10 and ubidecarenone as an oral ingredient in listed therapeutic goods, provided that the total maximum daily dose of the two substances does not exceed 300 mg.

This daily limit is consistent with the daily dose considered safe by Health Canada for nutritional supplements containing ubiquinol-10 in its jurisdiction. Further, noting that ubiquinol-10 readily converts in the body to ubidecarenone, this daily limit acknowledges the interconversion of ubiquinol-10 and ubidecarenone.

While the risk assessment for ubiquinol-10 found that there is evidence to support the safe use of ‘ubiquinol-10’ as a therapeutically active ingredient, there is a potential that ubiquinol-10 may interact with warfarin-containing medicines. As such, the TGA considers ubiquinol-10 suitable for use in listed medicines, subject to a label warning statement that is also required for listed medicines containing ubidecarenone.

To that end, the delegate of the Minister has determined that therapeutic goods containing ubiquinol-10 as a therapeutically active ingredient be included in the part of the Register for listed goods when the preparations are:

for oral use only; and
the preparations provide not more than 300 mg ubiquinol-10 per daily dose; and

when used in combination with ubidecarenone, the preparations provide not more than 300 mg of ubiquinol-10 and ubidecarenone combined per daily dose; and

the container, and any other packaging, for the preparation is labelled with the following warning:

“Not to be taken, if on warfarin therapy, without medical advice”.

The current Listing Notice therefore replaces and revokes Therapeutic Goods (Listing) Notice 2012 (No. 3).

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 this Listing Notice is that sponsors wishing to use ‘ubiquinol-10’ 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 2015 (No. 1) – ‘ubiquinol-10’

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 2015 (No. 1) (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 ‘ubiquinol-10’ 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 2015 (No. 1) was enacted under subsection 9A(5) of the Therapeutic Goods Act 1989, aiming to address the inclusion of therapeutic goods containing 'Ubiquinol-10' as a therapeutically active ingredient in the Australian Register of Therapeutic Goods. This notice, published by the delegate of the Minister for Health, revokes the Therapeutic Goods (Listing) Notice 2012 (No. 3) and requires these goods to be listed in the Register for listed goods, subject to certain conditions. The Therapeutic Goods Administration (TGA) is responsible for administering the Act, and the enactment of this notice facilitates a more accessible process for including such goods in the Register, allowing for the listing rather than the more rigorous registration process. This change aims to provide a more streamlined pathway for manufacturers to bring these products to market, while maintaining safety and quality standards. The notice commenced on the day after its registration on the Federal Register of Legislative Instruments, and its introduction fills a gap in the regulatory framework by providing specific guidelines for the inclusion of ubiquinol-10 in listed medicines, reflecting the latest safety assessments and aligning with international standards. This legislative instrument, deemed minor and of a machinery nature with low compliance costs, has been assessed as compatible with human rights as it does not engage any of the applicable rights or freedoms.

Scope and Application

The Therapeutic Goods (Listing) Notice 2015 (No. 1) is a directive issued under subsection 9A(5) of the Therapeutic Goods Act 1989 by the delegate of the Minister for Health, aimed at modifying the requirements for listing certain therapeutic goods in the Australian Register of Therapeutic Goods (ARTG). This notice mandates that therapeutic goods containing 'Ubiquinol-10' as a therapeutically active ingredient be included in the ARTG for listed goods, provided they meet specific conditions. This legislative instrument applies to manufacturers, sponsors, and suppliers of therapeutic goods that contain Ubiquinol-10, which is the reduced form of coenzyme Q10, a key component for energy production in human cells. The scope of the notice is national, aligning with the Commonwealth's responsibility to regulate therapeutic goods across Australia to ensure their quality, safety, and efficacy. The notice revokes the previous Therapeutic Goods (Listing) Notice 2012 (No. 3), allowing for an increased daily dose of Ubiquinol-10, up to 300 mg per day, when used in combination with ubidecarenone, provided the total combined dose does not exceed 300 mg. Additionally, it mandates a warning label advising against use by individuals on warfarin therapy without medical advice. The notice does not extend its application to therapeutic goods not containing Ubiquinol-10, or those that do not meet the specified conditions. The Therapeutic Goods Administration (TGA) evaluates applications for listing based on safety and quality, ensuring that the ingredients meet the required standards for inclusion in listed medicines.

Key Provisions

The Therapeutic Goods (Listing) Notice 2015 (No. 1) (the Notice) is a regulatory instrument made under subsection 9A(5) of the Therapeutic Goods Act 1989 (the Act). This Notice revokes the Therapeutic Goods (Listing) Notice 2012 (No.3) and mandates that therapeutic goods containing ‘Ubiquinol-10’ as a therapeutically active ingredient must be included in the part of the Australian Register of Therapeutic Goods (the Register) designated for listed goods, subject to specific conditions (sections 1(1) and 1(2)). The Notice imposes certain conditions for the inclusion of goods containing Ubiquinol-10 in the Register. These include that the preparations must be for oral use only, provide not more than 300 mg of Ubiquinol-10 per daily dose, and if used in combination with ubidecarenone, the total combined daily dose of both substances must not exceed 300 mg (section 1(3)(a)-(c)). Additionally, any packaging must bear a label advisory statement warning against potential interaction with warfarin-containing medicines (section 1(3)(d)). These conditions are designed to ensure the safety and efficacy of the therapeutic goods. The Notice does not explicitly outline specific offences, penalties, or consequences for breach within its text. However, under the Therapeutic Goods Act 1989, breaches of the Act or regulations can result in both civil and criminal penalties. For instance, supplying therapeutic goods that do not comply with the Act or regulations can lead to fines and imprisonment (section 32). The maximum penalties can vary significantly depending on the severity of the breach, but they may include substantial fines and imprisonment terms. Failure to comply with the listing requirements can also lead to the goods being deemed illegal and subject to enforcement actions by the Therapeutic Goods Administration (TGA). Overall, the Notice aims to streamline the process for including therapeutic goods containing Ubiquinol-10 in the Register by allowing a listing process rather than requiring full registration. This approach reduces the regulatory burden and costs for sponsors, facilitating quicker access to the market for these goods, provided they meet the specified conditions.

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