EXPLANATORY STATEMENT
THERAPEUTIC GOODS (LISTING) NOTICE 2008 (No. 2)
Euphausia superba oil
Section 9A(5), Therapeutic Goods Act 1989
OUTLINE
Therapeutic Goods (Listing) Notice 2008 (No. 2) (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 permits the use of Euphausia superba oil (krill oil) as an active ingredient in Listed complementary medicines for oral use.
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 (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 (ARTG) before being supplied in, imported into, manufactured in, or exported from Australia (section 19B and 19C 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 such as vitamins, minerals, nutritional supplements and herbal, aromatherapy and homoeopathic products are regulated as ‘complementary’ medicines. Most, but not all, complementary medicines are considered to be of relatively low risk compared to other types of medicines, such as prescription and over-the-counter medicines, and are Listed in the ARTG. Listed medicines may only contain ingredients that have been approved by the TGA as being of low risk and may only make certain 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 is for substances other than vitamins, minerals and plant material that are for use in Listed medicines. Division 1 of Part 5 is for substances for which no dosage limit is specified in the Regulations.
In order to facilitate the timely approval of new Listable substances, subsection 9A(5) of the Act allows the Minister for Health and Ageing to publish a Listing Notice that has the effect of permitting the use of particular substances in Listed medicines subject to any specified conditions.
Pursuant to subsection 9A(6) of the Act, when Schedule 4 of the Regulations is amended to include reference to a substance that has been the subject of Listing Notice, the Listing Notice ceases to have effect.
The proposed ingredient is a fatty acid-rich phospholipid and carotenoid-rich oil derived from the crustacean Euphausia superba, a small prawn like invertebrate known commonly as the Antarctic krill. Antarctic krill oil has chemical similarities to fish oils and omega-3-marine triglycerides, ingredients which are approved for use in Listed medicines. Euphausia superba is harvested from the Antarctic region of the Southern Ocean. Antarctic krill harvesting began in the mid-1970s. Several Antarctic krill products have been developed including aquaculture feed, food for human consumption, a concentrate marketed as a food additive and health food, chitin, enzymes, and oil.
The 59th Complementary Medicines Evaluation Committee (CMEC) meeting was asked to advise whether Antarctic krill oil is suitable as an ingredient in Listed medicines. CMEC is a statutory body established under subsection 52G(1) of the Act. CMEC provides scientific and policy advice to the Minister for Health and Ageing and the Secretary to the Department of Health and Ageing relating to controls on the supply and use of complementary medicines. CMEC provides this advice with particular reference to the safety and quality of products and, where appropriate, efficacy relating to the claims made for products. CMEC has recommended that this ingredient is suitable for use as an ingredient in oral Listed medicines.
CONSULTATION
Although no consultation is required in relation to the Listing Notice as the regulation change is minor and machinery in nature, the TGA has consulted the Complementary Medicines Evaluation Committee during the approval process for this ingredient.
REGULATION IMPACT STATEMENT
No Regulation Impact Statement is necessary in relation to the Listing Notice as the regulation change is minor and machinery in nature.
Overview
The Therapeutic Goods (Listing) Notice 2008 (No. 2), enacted to address the inclusion of Euphausia superba oil (krill oil) as an active ingredient in Listed complementary medicines, was introduced under subsection 9A(5) of the Therapeutic Goods Act 1989 by the delegate of the Minister for Health and Ageing. This legislative instrument was designed to facilitate the timely approval of new substances for use in Listed medicines, ensuring they meet the necessary safety and quality standards. The policy objective behind this Notice is to allow the incorporation of substances like krill oil, which have been evaluated and deemed suitable by the Complementary Medicines Evaluation Committee (CMEC). This approach streamlines the regulatory process for introducing new ingredients into the Australian Register of Therapeutic Goods (ARTG), enhancing the availability of complementary medicines that are considered to be of relatively low risk.
Scope and Application
The Therapeutic Goods (Listing) Notice 2008 (No. 2) applies to the use of Euphausia superba oil, commonly known as krill oil, as an active ingredient in Listed complementary medicines for oral use. This Notice, made by the delegate of the Minister for Health and Ageing under subsection 9A(5) of the Therapeutic Goods Act 1989, facilitates the inclusion of krill oil in oral Listed medicines, subject to specified conditions. The Act itself governs the quality, safety, efficacy, and timely availability of therapeutic goods in Australia, with the Therapeutic Goods Administration (TGA) responsible for its administration. The Listing Notice operates nationally, aligning with the broader scope of the Therapeutic Goods Act which applies throughout Australia. The notice does not require specific consultation as the change is minor and procedural; however, the TGA has consulted with the Complementary Medicines Evaluation Committee during the approval process. The Listing Notice commenced on the day after its registration on the Federal Register of Legislative Instruments.
Key Provisions
The Therapeutic Goods (Listing) Notice 2008 (No. 2) (sections 9A(5) of the Therapeutic Goods Act 1989) facilitates the use of Euphausia superba oil, commonly known as krill oil, as an active ingredient in Listed complementary medicines intended for oral consumption. This Listing Notice was issued by the delegate of the Minister for Health and Ageing, thereby allowing the inclusion of this oil in the Australian Register of Therapeutic Goods (ARTG). The Listing Notice came into effect on the day following its registration on the Federal Register of Legislative Instruments. This legislative measure is designed to ensure that therapeutic goods available in Australia meet standards of quality, safety, efficacy, and timely availability, with the Therapeutic Goods Administration (TGA) overseeing its implementation.
Under the Therapeutic Goods Act 1989, therapeutic goods must be listed in the ARTG unless they are specifically exempted or authorised. Section 19B and 19C of the Act mandate that these goods must be included in the ARTG before being supplied, imported, manufactured, or exported within Australia. The ARTG differentiates between Registered and Listed medicines based on their ingredients and therapeutic claims. Complementary medicines, such as vitamins, minerals, nutritional supplements, and herbal products, are typically Listed in the ARTG due to their generally perceived lower risk compared to prescription and over-the-counter medicines. Listed medicines are restricted to ingredients approved by the TGA as low-risk and are limited in the therapeutic claims they can make.
The Therapeutic Goods Regulations 1990 outline the substances that must be included in the ARTG for Listed medicines, with Schedule 4 detailing those substances. Part 5 of Schedule 4 pertains to substances other than vitamins, minerals, and plant material, with Division 1 covering substances without a specified dosage limit. The Listing Notice enables the Minister for Health and Ageing to permit the use of specific substances in Listed medicines, subject to any conditions specified. Once Schedule 4 of the Regulations is amended to reference a substance that has been the subject of a Listing Notice, the Listing Notice ceases to have effect.
Failure to comply with the requirements of the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990 can result in civil and criminal penalties. Offences under the Act may include supplying therapeutic goods that do not comply with the standards set by the TGA, with potential penalties ranging from fines to imprisonment. The specific penalties depend on the nature and severity of the offence, as outlined in the Act and any relevant regulations. The TGA is responsible for enforcing these provisions, ensuring that therapeutic goods available in Australia meet the necessary standards for quality, safety, and efficacy.