EXPLANATORY STATEMENT
THERAPEUTIC GOODS (LISTING) NOTICE 2007 (No. 1)
Fish Oil, Rich in Omega-3-Acids
Section 9A(5), Therapeutic Goods Act 1989
OUTLINE
Therapeutic Goods (Listing) Notice 2007 (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 permits the use of Fish Oil, Rich in Omega-3-Acids (as described in the British Pharmacopoeia 2005) 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 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.
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 ingredient Fish Oil, Rich in Omega-3-Acids, as defined in the British Pharmacopoeia, is a type of oil that falls under the historical (approved) active, “Fish oil - natural”.
CONSULTATION
The Complementary Medicines Evaluation Committee and Office of Complementary Medicines / Industry Consultation Group have been consulted 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 2007 (No. 1) was enacted to address the need for timely approval of new Listable substances for use in Listed complementary medicines. This Notice was issued by the delegate of the Minister for Health and Ageing under subsection 9A(5) of the Therapeutic Goods Act 1989, which establishes a national system for the regulation of therapeutic goods in Australia. The Therapeutic Goods Administration (TGA) administers this Act, ensuring the quality, safety, efficacy, and timely availability of therapeutic goods used or exported from Australia. The primary policy objective of this legislation is to facilitate the inclusion of Fish Oil, Rich in Omega-3-Acids, as defined in the British Pharmacopoeia, in Listed complementary medicines for oral use. This Notice allows for the use of this substance in Listed medicines, subject to any specified conditions, thereby supporting the availability of low-risk therapeutic products. The consultation process involved the Complementary Medicines Evaluation Committee and the Office of Complementary Medicines/Industry Consultation Group, ensuring that the approval process for this ingredient was thorough and inclusive.
Scope and Application
The Therapeutic Goods (Listing) Notice 2007 (No. 1) pertains to Fish Oil, Rich in Omega-3-Acids, as described in the British Pharmacopoeia 2005, being approved for use as an active ingredient in Listed complementary medicines intended for oral consumption. This Notice was made by the delegate of the Minister for Health and Ageing under section 9A(5) of the Therapeutic Goods Act 1989. The Act governs the national regulatory framework for therapeutic goods, ensuring their quality, safety, efficacy, and timely availability for use or export from Australia. The Therapeutic Goods Administration (TGA) administers this Act and requires that therapeutic goods be included in the Australian Register of Therapeutic Goods (ARTG) unless exempted, prior to their supply, import, manufacture, or export. Complementary medicines, including vitamins, minerals, nutritional supplements, and herbal, aromatherapy, and homeopathic products, are regulated under this framework, with most listed in the ARTG due to their relatively low risk. The Notice facilitates the timely approval of new Listable substances and permits the use of Fish Oil, Rich in Omega-3-Acids in Listed medicines subject to any specified conditions. The Listing Notice became effective the day after its registration on the Federal Register of Legislative Instruments.
Key Provisions
The Therapeutic Goods (Listing) Notice 2007 (No. 1) (the Listing Notice) under subsection 9A(5) of the Therapeutic Goods Act 1989 (the Act) allows the use of Fish Oil, Rich in Omega-3-Acids (as described in the British Pharmacopoeia 2005) as an active ingredient in Listed complementary medicines for oral use. This Listing Notice was issued by the delegate of the Minister for Health and Ageing and came into effect immediately after its registration on the Federal Register of Legislative Instruments.
The Listing Notice mandates that Fish Oil, Rich in Omega-3-Acids can be incorporated into Listed complementary medicines, which are those products containing approved low-risk ingredients and making specified therapeutic claims. These medicines are regulated under the Act and must be included in the Australian Register of Therapeutic Goods (ARTG) before being supplied in, imported into, manufactured in, or exported from Australia (sections 19B and 19C of the Act). This requirement ensures that all therapeutic goods available in Australia meet certain quality, safety, and efficacy standards, and that consumers have access to reliable information about these products.
Entities and individuals involved in the manufacture, supply, or importation of complementary medicines containing Fish Oil, Rich in Omega-3-Acids must ensure compliance with the Act and the Regulations. This includes adhering to the specific conditions outlined in the Listing Notice and ensuring that these products are appropriately listed in the ARTG. Failure to comply with these requirements could result in legal repercussions, including penalties for non-compliance.
Breaches of the Therapeutic Goods Act 1989 may lead to civil or criminal penalties. For instance, supplying therapeutic goods that do not comply with the requirements of the Act could result in substantial fines and, in severe cases, imprisonment. The specific penalties vary depending on the nature and extent of the breach but can include fines up to $275,000 for corporations and $55,000 for individuals, as well as potential imprisonment terms. It is crucial for all parties involved to understand and comply with the Act to avoid these severe consequences.