EXPLANATORY STATEMENT
THERAPEUTIC GOODS (LISTING) NOTICE 2006 (No. 4)
Concentrated omega-3 triglycerides-fish
Section 9A(5), Therapeutic Goods Act 1989
OUTLINE
Therapeutic Goods (Listing) Notice 2006 (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 permits the use of concentrated omega-3 triglycerides-fish (the substance described as Omega-3-Marine Triglycerides 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.
At its 58th meeting, the Complementary Medicines Evaluation Committee (CMEC) recommended to the TGA that the substance defined in the British Pharmacopoeia 2005 as Omega-3-Marine Triglycerides is suitable for use as an ingredient in Listed medicines for oral use.
The TGA then consulted with industry to ascertain the most suitable description of the substance for the Australian market. Through this consultation process, the Australian Approved Name “Concentrated omega-3 triglycerides-fish” was developed.
CONSULTATION
This substance has been reviewed by the Complementary Medicines Evaluation Committee (CMEC), which is comprised of some of Australia’s leading experts on complementary medicines. CMEC provides scientific and policy advice to the TGA relating to controls on the supply and use of complementary medicines, with particular reference to safety, quality and where appropriate, efficacy.
CMEC recommended to the TGA that Omega-3-Marine Triglycerides (as defined in the British Pharmacopoeia 2005) is suitable for use as an ingredient in oral Listed medicines.
The Australian Approved name, Concentrated omega-3 triglycerides-fish, was developed in consultation with Industry.
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.