Therapeutic Goods (Listing) Notice 2013 (No. 2)

Administered by Department of Health, Disability and Ageing

Legislation au F2013L00777 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

THERAPEUTIC GOODS (LISTING) NOTICE 2013 (NO. 2)

 

Subsection 9A(5), Therapeutic Goods Act 1989

 

OUTLINE

Therapeutic Goods (Listing) Notice 2013 (No. 2) (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 ‘squid oil’ 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 ‘squid oil’ 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 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 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 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 substance.

 

Squid oil

 

‘Squid oil’ is obtained from trimmings of squid (order Teuthida, class Cephalopoda) used in food production. Like many other marine oils, ‘squid oil’ contains omega-3 fatty acids such as docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA). The oil is purified and deodorised with the possible addition of suitable antioxidants.

 

‘Squid oil’ is similar to a range of other permitted marine organism-derived oils, e.g., ‘Fish oil, rich in omega-3 acids’, and this compositional similarity means that the safety of  squid oil as a therapeutically active ingredient in listed medicines (subject to the conditions set out in the Listing Notice) is considered to have been established.

To that end, the delegate of the Minister has determined that therapeutic goods containing ‘squid oil’ as a therapeutically active ingredient be included in the part of the Register for listed goods when:

 

  • the preparations are for oral use only;
  • the ‘squid oil’ is obtained from species of the order Teuthida of the class Cephalopoda;
  • the squid oil is in combination with other ingredients;
  • the preparations are presented in a therapeutic dosage form for therapeutic use; and
  • the container, and any other packaging for the goods, is labelled with the warning:
    “DERIVED FROM SEAFOOD”.

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 ‘squid oil’. This will be available on the TGA’s website (www.tga.gov.au) for consultation for six weeks following the registration of the Listing Notice. The Compositional Guideline will then be published on the TGA’s website in its final form.

Compositional guidelines are intended to assist applicants for the listing of therapeutic goods in the Register that are goods of a kind described in a listing notice in identifying the specific forms or types of ingredients or substances where, as in this case, there is no monograph in the British Pharmacopoeia, United States Pharmacopoeia-National Formulary or European Pharmacopoeia in relation to the ingredient or substance in question.


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 ‘squid oil’ 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 Office of Best Practice Regulation (OBPR) has advised that a regulatory impact statement (RIS) 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 attached as Supporting material.

 

Overview

The Therapeutic Goods (Listing) Notice 2013 (No. 2) was enacted to address the gap in the Therapeutic Goods Act 1989 concerning the inclusion of therapeutic goods containing squid oil as a therapeutically active ingredient in the Australian Register of Therapeutic Goods (ARTG). This notice, made by the delegate of the Minister for Health under subsection 9A(5) of the Act, aims to ensure that such goods, subject to specified conditions, are listed in the ARTG for listed goods. This initiative facilitates a more streamlined process for listing these goods compared to the more rigorous and time-consuming registration process required for other therapeutic goods. The notice came into effect the day after its registration on the Federal Register of Legislative Instruments, underscoring the government’s commitment to efficiently manage the quality, safety, and efficacy of therapeutic goods in Australia.

Scope and Application

The Therapeutic Goods (Listing) Notice 2013 (No. 2) pertains to the regulation of therapeutic goods containing 'squid oil' as a therapeutically active ingredient. This notice, made under subsection 9A(5) of the Therapeutic Goods Act 1989, mandates the inclusion of such goods in the Australian Register of Therapeutic Goods (ARTG) for listed goods, subject to specific conditions. It applies to entities and individuals involved in the supply, import, manufacture, or export of therapeutic goods containing squid oil, ensuring compliance with national standards for quality, safety, and efficacy. The notice's jurisdiction extends across Australia, impacting industries involved in the production and distribution of listed medicines. The notice specifies that squid oil must be derived from species of the order Teuthida of the class Cephalopoda, be used in combination with other ingredients, and presented in a therapeutic dosage form. Additionally, the packaging must include a warning stating "DERIVED FROM SEAFOOD." The notice came into effect on the day after its registration on the Federal Register of Legislative Instruments. It is noteworthy that the notice does not require consultation as it is considered minor and machinery in nature, with low compliance costs for the industry. The Therapeutic Goods Administration (TGA) is responsible for evaluating applications for the listing of these goods on the ARTG, providing a more streamlined process compared to the full evaluation required for registered medicines.

Key Provisions

The Therapeutic Goods (Listing) Notice 2013 (No. 2) (Listing Notice), issued under subsection 9A(5) of the Therapeutic Goods Act 1989 (the Act), mandates that therapeutic goods containing 'squid oil' as a therapeutically active ingredient be listed in the Australian Register of Therapeutic Goods (the Register). The Listing Notice came into effect following its registration on the Federal Register of Legislative Instruments. The purpose of this notice is to ensure that certain therapeutic goods, specifically those containing squid oil, are included in the Register for listed goods, subject to specific conditions. These conditions include the requirement that the preparations be for oral use only, the squid oil must be derived from species of the order Teuthida of the class Cephalopoda, it must be combined with other ingredients, presented in a therapeutic dosage form, and the packaging must be labelled with a warning stating "DERIVED FROM SEAFOOD" (subsection 9A(5) of the Act). The Listing Notice imposes several obligations on entities and individuals involved in the supply of therapeutic goods containing squid oil. Firstly, it mandates that such goods be listed in the Register for listed goods rather than being registered as new medicines. This listing process is less rigorous than the registration process but still requires compliance with certain standards. The Therapeutic Goods Administration (TGA) is responsible for evaluating applications for listing to ensure that the therapeutic goods meet the necessary safety and quality standards. Secondly, the Listing Notice requires that the preparations be labelled with the warning "DERIVED FROM SEAFOOD" to inform consumers of the source of the active ingredient (subsection 9A(5) of the Act). This labelling requirement ensures that consumers are adequately informed about the composition of the therapeutic goods. Breach of the provisions of the Therapeutic Goods (Listing) Notice 2013 (No. 2) can result in various consequences. Firstly, supplying therapeutic goods that do not comply with the Listing Notice may result in the goods being considered unlisted, which means they cannot be legally supplied in Australia. This non-compliance can lead to legal action being taken against the supplier by the TGA. Furthermore, if a person or entity supplies therapeutic goods that are not listed in the Register, they may be subject to fines and penalties as prescribed by the Therapeutic Goods Act 1989. The maximum penalties for contravening the Act can include substantial fines and, in severe cases, imprisonment. These penalties serve as a deterrent to ensure compliance with the legislative requirements and to protect public health and safety.

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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.