Therapeutic Goods (Listing) Notice 2010 (No. 4)

Administered by Department of Health, Disability and Ageing

Legislation au F2010L03305 Not in force Legislative Instrument

Select Document

EXPLANATORY STATEMENT

THERAPEUTIC GOODS (LISTING) NOTICE 2010 (NO. 4)

Docosahexaenoic acid (DHA)-rich oil derived from microalgae Schizochytrium sp.

Subsection 9A(5), Therapeutic Goods Act 1989

OUTLINE

Therapeutic Goods (Listing) Notice 2010 (No. 4) (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 requiring that therapeutic goods that are oral preparations containing ‘Docosahexaenoic acid (DHA)-rich oil derived from microalgae Schizochytrium sp.’ as a therapeutically active ingredient in combination with other ingredients and that are presented in a therapeutic dosage form for therapeutic use 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.

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 medicines. It does not currently cover oral preparations that contain DHA-rich oil derived from microalgae Schizochytrium sp. as a therapeutically active ingredient in combination with other ingredients and that are presented in a therapeutic dosage form for therapeutic use.

Subsection 9A(5) of the Act authorises the Minister for Health and Ageing 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 and allowing the Minister to specify conditions to which such an inclusion is to be subject. 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 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 approved for inclusion as an active ingredient in listed medicines through the making of a subsection 9A(5) notice. 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.

DHA-RICH OIL DERIVED FROM MICROALGAE SCHIZOCHYTRIUM SP.

An application was received for DHA-rich oil derived from microalgae Schizochytrium sp. to be made available for use in listed medicines. This substance is the purified form of the oil that is produced by the organism Schizochytrium sp. under closed, sterile conditions. In nature Schizochytrium sp. is widely distributed in marine environments.

The oil is primarily a mixture of triglycerides enriched in the omega-3 fatty acid DHA and also contains relatively high levels of the omega-6 fatty acid docosapentaenoic acid. The oil is manufactured in a process similar to that used for edible vegetable oils.

Other marine oils containing triglycerides rich in omega-3 fatty acids that are currently approved active ingredients in listed medicines for oral use include oils from a range of fish species and Euphausia superba (Antarctic krill). These substances are available for use in listed medicines without restriction. The DHA-rich oil derived from microalgae Schizochytrium sp. alone was considered safe for use as a novel food by the then Australia New Zealand Food Authority (now Food Standards Australia New Zealand) in 2002.

The delegate of the Minister for Health and Ageing has made the Listing Notice, which is a legislative instrument for the purposes of the Legislative Instrument Act 2003, to require that oral preparations that contain DHA-rich oil derived from microalgae Schizochytrium sp. as a therapeutically active ingredient in combination with other ingredients and that are presented in a therapeutic dosage form for therapeutic use, be included in the part of the Register for listed goods. This will have the effect of permitting the use of DHA rich oil derived from microalgae Schizochytrium sp. in oral listed medicines in combination with other ingredients (such as, for example, binders, fillers and other excipients) when the medicine is presented in a therapeutic dosage form for therapeutic use.

The TGA has also prepared a physico-chemical description of DHA-rich oil derived from microalgae Schizochytrium sp. in the form of compositional guidelines. Compositional guidelines are intended to assist applicants for inclusion of therapeutic goods on the Register that are or include goods of the kind described in a subsection 9A(5) notice in identifying the specific forms or types of ingredients or substances where, as in this case, there is no standard in the British Pharmacopoeia or other acceptable monographs in relation to the ingredient or substance.

The draft compositional guidelines for DHA-rich oil derived from microalgae Schizochytrium sp. will be available on the TGA’s internet site (www.tga.gov.au) for consultation for six months from the date of registration of the Listing Notice. The guidelines will then be published on the website in their final form.

CONSULTATION

The making of the Listing Notice 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. 4), enacted under the authority of subsection 9A(5) of the Therapeutic Goods Act 1989, addresses the need to regulate the use of Docosahexaenoic acid (DHA)-rich oil derived from microalgae Schizochytrium sp. in oral therapeutic preparations in Australia. This legislation was introduced to ensure that these specific therapeutic goods are included in the Australian Register of Therapeutic Goods (ARTG) for listed goods. The enactment body responsible for this notice is the delegate of the Minister for Health and Ageing, acting on behalf of the Australian Government. The policy objective is to maintain a national system of controls that ensures the quality, safety, efficacy, and timely availability of therapeutic goods in Australia, including those that are exported from the country. The notice facilitates the inclusion of DHA-rich oil derived from microalgae Schizochytrium sp. in listed medicines, provided it is presented in a therapeutic dosage form, thus enabling its use in oral preparations alongside other therapeutically active ingredients. This legislative instrument also mandates the preparation of compositional guidelines for the substance in question, to be published on the Therapeutic Goods Administration's website for public consultation. These guidelines will assist applicants in ensuring that the DHA-rich oil meets the necessary standards for inclusion on the ARTG. The Listing Notice is considered minor in nature, with minimal compliance costs and impact on business, individuals, or the economy, ensuring that the introduction of this new therapeutic ingredient is managed in a controlled and transparent manner.

Scope and Application

The Therapeutic Goods (Listing) Notice 2010 (No. 4) is a legislative instrument made by the delegate of the Minister for Health and Ageing under subsection 9A(5) of the Therapeutic Goods Act 1989. This notice mandates the inclusion of oral preparations containing docosahexaenoic acid (DHA)-rich oil derived from microalgae Schizochytrium sp. as a therapeutically active ingredient, when combined with other ingredients and presented in a therapeutic dosage form for therapeutic use, in the part of the Australian Register of Therapeutic Goods (the Register) designated for listed goods. The notice came into effect on the day following its registration on the Federal Register of Legislative Instruments. This legislative instrument applies to entities and individuals involved in the supply, importation, manufacture, or export of therapeutic goods in Australia, specifically targeting those producing or distributing oral preparations containing the specified DHA-rich oil. The notice extends to all oral preparations intended for therapeutic use that meet the criteria outlined, including those presented in a therapeutic dosage form. The scope of this notice is national, applying across the Commonwealth of Australia. There are no explicit exclusions or exemptions detailed in the notice itself, though any existing exemptions or authorisations under the Therapeutic Goods Act 1989 would apply. The notice is subject to cessation if Part 1 of Schedule 4 to the Therapeutic Goods Regulations 1990 is amended to include the specified goods in the Register for listed goods, as per subsection 9A(6) of the Act.

Key Provisions

The Therapeutic Goods (Listing) Notice 2010 (No. 4) requires that oral preparations containing Docosahexaenoic acid (DHA)-rich oil derived from microalgae Schizochytrium sp. as a therapeutically active ingredient be included in the Australian Register of Therapeutic Goods (the Register) for listed goods (subsection 9A(5) of the Therapeutic Goods Act 1989). This inclusion permits these oral preparations to be supplied in, imported into, manufactured in, or exported from Australia when they meet the conditions specified in the notice (sections 19B and 19D of the Act). The notice ensures that such preparations are subject to the regulatory requirements applicable to listed medicines, including safety and quality standards enforced by the Therapeutic Goods Administration (TGA). The Listing Notice imposes several obligations on parties involved in the supply, importation, manufacture, or export of these oral preparations. Firstly, these preparations must comply with the requirements for listing on the Register, which includes providing detailed information about the composition, manufacturing process, and intended use of the preparations. Secondly, any entity seeking to supply these preparations in Australia must ensure they are listed on the Register before any such supply takes place. Thirdly, manufacturers and importers are required to maintain records and documentation that demonstrate compliance with the Act and the associated regulations. Breach of the obligations imposed by the Listing Notice can result in significant consequences. Under the Therapeutic Goods Act 1989, unauthorised supply of therapeutic goods not included on the Register constitutes an offence, with potential criminal penalties. For individuals, the maximum penalty includes a fine of up to $162,000 or imprisonment for up to five years, or both (section 36(1) of the Act). For corporations, the maximum penalty can be up to $810,000 (section 36(2) of the Act). Additionally, civil penalties may apply, including fines for non-compliance, which can vary based on the severity and frequency of the breach. The Act also empowers the TGA to take enforcement actions, such as seizing non-compliant goods or issuing compliance notices.

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

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.

Legislation content