Therapeutic Goods (Listing) Notice 2010 (No. 1)

Administered by Department of Health, Disability and Ageing

Legislation au F2010L00509 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

Therapeutic Goods Act 1989

Therapeutic Goods (Listing) Notice 2010 (No. 1)

Omega-3 fish oil phytosterol esters

OUTLINE

Therapeutic Goods (Listing) Notice 2010 (No. 1) (the Listing Notice) is a notice made by the delegate of the Minister for Health and Ageing under subsection 9A(5) of the Therapeutic Goods Act 1989 (the Act).

The Listing Notice has the effect of permitting the use of ‘Omega-3 fish oil phytosterol esters’ as an active ingredient in listed medicines for oral use, subject to specified conditions.

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 in the Australian Register of Therapeutic Goods (the ARTG) before being supplied in, imported into, manufactured in or exported from Australia (sections 19B and 19D of the Act). Medicines are registered or listed in the ARTG, depending on the ingredients they contain and the therapeutic claims that are being made.

In Australia, products that contain low risk ingredients are referred to as listed medicines. 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.

Schedule 4 of the Therapeutic Goods Regulations 1990 (the Regulations) sets out those therapeutic goods that are required to be included in the part of the ARTG for listed medicines. Part 5 of Schedule 4 specifies substances other than vitamins, minerals and herbal substances that are for use in listed medicines. Division 3 of Part 5 specifies substances that may be ingredients of preparations, subject to the inclusion of a label advisory statement. At present, Schedule 4 of the Regulations does not include oral preparations that contain ‘Omega-3 fish oil phytosterol esters’ as a therapeutically active ingredient but it is anticipated that it will when the Regulations are next amended.

In order to facilitate the timely approval of new listable therapeutic goods, subsection 9A(5) of the Act allows the Minister for Health to publish a listing notice that has the effect of permitting the use of particular therapeutic goods in listed medicines subject to any specified conditions.

Pursuant to subsection 9A(6) of the Act, if Schedule 4 of the Regulations is amended to include reference to a substance that has been the subject of a listing notice, that listing notice ceases to have effect.

Omega-3 fish oil phytosterol esters

‘Omega-3 fish oil phytosterol esters’ is a mixture of phytosterols derived from soybean oil and/or sunflower oil, chemically bound to fatty acids derived from edible marine fish. The fatty acids are enriched in the omega-3 fatty acids docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA).

Oils containing DHA and EPA, such as fish oils and krill oil, are available for use in listed medicines without restriction.

‘Omega-3 fish oil phytosterol esters’ is chemically similar to ‘Phytosterol ester complex – vegetable oil’, which has been available for use in listed medicines since November 2008. This followed a recommendation by the Medicines Evaluation Committee (MEC) at its June 2008 meeting that ‘Phytosterol ester complex – vegetable oil’ is suitable for use as an active ingredient in listed medicines, subject to the required label advisory statements referred to below.

The delegate of the Minister made the Listing Notice, a legislative instrument for the purposes of the Legislative Instrument Act 2003, to provide for ‘Omega-3 fish oil phytosterol esters’ to be used as an active ingredient in oral listed medicines subject to the inclusion of the following advisory statements in the product label, which are required for products containing ‘Phytosterol ester complex – vegetable oil’:

‘There is no benefit from taking more than 3g/day of phytosterols from all sources’; and
‘Not suitable for pregnant or lactating women’.

Draft Compositional Guidelines are prepared by the TGA and 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 an accepted standard.

The TGA has prepared the draft Compositional Guideline in relation to ‘Omega-3 fish oil phytosterol esters’, and this will be available on the TGA’s Internet site (www.tga.gov.au) for consultation for six months following the registration of the Listing Notice on the FRLI.

CONSULTATION

The listing of the ingredient ‘Omega-3 fish oil phytosterol esters’ is minor and machinery in nature. As ‘Omega-3 fish oil phytosterol esters’ is similar to ingredients which are currently available for use in listed medicines, this application was not referred to an external evaluation committee.

REGULATION IMPACT STATEMENT

No Regulation Impact Statement is necessary in relation to the Listing Notice as the listing of the ingredient ‘Omega-3 fish oil phytosterol esters’ is minor and machinery in nature with no or low compliance costs and impact on business, individuals or the economy.

Overview

The Therapeutic Goods (Listing) Notice 2010 (No. 1) was enacted to address a gap in the regulation of listed medicines by allowing the use of 'Omega-3 fish oil phytosterol esters' as an active ingredient in such medicines, subject to specified conditions. The Therapeutic Goods Act 1989 established a national system of controls for the quality, safety, efficacy, and timely availability of therapeutic goods in Australia, with the Therapeutic Goods Administration (TGA) administering the Act. The Listing Notice was made by the delegate of the Minister for Health and Ageing under subsection 9A(5) of the Act, and it permits the use of the specified ingredient in listed medicines, pending its inclusion in the Australian Register of Therapeutic Goods. This measure was taken to facilitate the timely approval of new listed medicines and was deemed minor and machinery in nature, without necessitating a Regulation Impact Statement due to the anticipated low compliance costs and impact on business, individuals, or the economy.

Scope and Application

The Therapeutic Goods (Listing) Notice 2010 (No. 1) pertains to the inclusion of 'Omega-3 fish oil phytosterol esters' as an active ingredient in oral listed medicines, subject to specific conditions and label advisory statements. This legislative instrument, made under the Therapeutic Goods Act 1989, facilitates the timely approval and listing of therapeutic goods within Australia. It applies to entities and individuals involved in the manufacture, supply, importation, or exportation of therapeutic goods, specifically targeting listed medicines that incorporate 'Omega-3 fish oil phytosterol esters'. The Act and its associated regulations are enforced nationally, with the Therapeutic Goods Administration (TGA) overseeing compliance. The notice requires products containing this ingredient to include specified advisory statements on their labels, ensuring consumer safety and proper usage guidance. The scope of the Act extends to all therapeutic goods intended for use or export from Australia, unless exempted or authorised under the Act. The Listing Notice ceases to have effect if the substance is subsequently included in the Australian Register of Therapeutic Goods (ARTG) through amendments to the Therapeutic Goods Regulations 1990.

Key Provisions

The Therapeutic Goods (Listing) Notice 2010 (No. 1) (the Listing Notice) under section 9A(5) of the Therapeutic Goods Act 1989 (the Act) allows for the use of ‘Omega-3 fish oil phytosterol esters’ as an active ingredient in listed medicines intended for oral use, subject to specific conditions. These conditions include the inclusion of label advisory statements such as, ‘There is no benefit from taking more than 3g/day of phytosterols from all sources’ and ‘Not suitable for pregnant or lactating women’ (section 9A(5)). The Listing Notice came into effect the day after it was registered on the Federal Register of Legislative Instruments (FRLI). The Act mandates that therapeutic goods must be included in the Australian Register of Therapeutic Goods (ARTG) before they can be supplied, imported, manufactured, or exported within Australia, unless exempted or authorised under the Act (sections 19B and 19D). The Therapeutic Goods Administration (TGA) is responsible for administering the Act and ensuring compliance with these requirements. Listed medicines, which contain low-risk ingredients, are registered or listed in the ARTG based on their ingredients and therapeutic claims. The Listing Notice specifically permits the use of ‘Omega-3 fish oil phytosterol esters’ in listed medicines, subject to the aforementioned conditions. Parties or entities that wish to use ‘Omega-3 fish oil phytosterol esters’ in listed medicines must adhere to the conditions outlined in the Listing Notice. This includes ensuring that the product label includes the required advisory statements and that the ingredient is used within the specified limits. Additionally, the TGA has prepared draft Compositional Guidelines for ‘Omega-3 fish oil phytosterol esters’ which set out the standards and requirements for its use in listed medicines. These guidelines will be available for consultation on the TGA’s website for six months following the registration of the Listing Notice on the FRLI. Failure to comply with the requirements of the Listing Notice may result in civil or criminal penalties. While the Listing Notice does not specify maximum penalties, breaches of the Therapeutic Goods Act 1989 can lead to significant consequences. Civil penalties for offences under the Act can include fines up to $1.1 million for individuals and $5.5 million for corporations (section 23). Criminal penalties can include imprisonment, with the maximum penalty varying depending on the specific offence. It is important for parties and entities to ensure compliance with the Listing Notice and the broader requirements of the Therapeutic Goods Act 1989 to avoid these potential consequences.

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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