Therapeutic Goods (Listing) Notice 2006 (No. 4)

Overview

The Therapeutic Goods (Listing) Notice 2006 (No. 4) was enacted to address the need for a national system of controls over the quality, safety, efficacy and timely availability of therapeutic goods in Australia. This Notice, made under the Therapeutic Goods Act 1989, permits the use of concentrated omega-3 triglycerides-fish, known as Omega-3-Marine Triglycerides in the British Pharmacopoeia 2005, as an active ingredient in Listed complementary medicines for oral use. This was done in response to a recommendation from the Complementary Medicines Evaluation Committee (CMEC) and consultation with industry to determine the most suitable description of the substance for the Australian market. The Therapeutic Goods Administration (TGA), responsible for administering the Act, developed the Australian Approved Name "Concentrated omega-3 triglycerides-fish" through this consultation process. The Notice was introduced to facilitate the timely approval of new Listable substances and commenced on the day after it was registered on the Federal Register of Legislative Instruments.

Scope and Application

The Therapeutic Goods (Listing) Notice 2006 (No. 4) is a legislative instrument made under the Therapeutic Goods Act 1989, facilitating the use of concentrated omega-3 triglycerides-fish as an active ingredient in Listed complementary medicines intended for oral use. This Notice applies nationally across Australia and is administered by the Therapeutic Goods Administration (TGA), which is responsible for ensuring that therapeutic goods meet quality, safety, efficacy, and availability standards. The Act requires that therapeutic goods be listed in the Australian Register of Therapeutic Goods (ARTG) unless exempted, and Listed medicines, including those containing approved low-risk ingredients, are subject to specific regulatory controls. The Notice was issued following a recommendation from the Complementary Medicines Evaluation Committee (CMEC), which reviewed and approved the substance defined in the British Pharmacopoeia 2005 as Omega-3-Marine Triglycerides for use in Listed medicines. The Australian Approved Name "Concentrated omega-3 triglycerides-fish" was determined through consultation with industry to reflect the appropriate description for the Australian market. The Notice, which commenced on the day after its registration on the Federal Register of Legislative Instruments, will remain in effect until amended by the Regulations under subsection 9A(6) of the Act.

Key Provisions

The Therapeutic Goods (Listing) Notice 2006 (No. 4) (Listing Notice) allows the use of concentrated omega-3 triglycerides-fish as an active ingredient in Listed complementary medicines for oral use, as stated in section 9A(5) of the Therapeutic Goods Act 1989 (the Act). This Notice was made by the delegate of the Minister for Health and Ageing and commenced on the day after its registration on the Federal Register of Legislative Instruments. It identifies concentrated omega-3 triglycerides-fish, which is described as Omega-3-Marine Triglycerides in the British Pharmacopoeia 2005, as a substance suitable for inclusion in Listed medicines. Under the Act, therapeutic goods must be included in the Australian Register of Therapeutic Goods (ARTG) unless exempted, which is stipulated in sections 19B and 19C of the Act. Complementary medicines, which include vitamins, minerals, nutritional supplements and certain natural products, are regulated and must be Listed in the ARTG. The Listing Notice specifies that concentrated omega-3 triglycerides-fish can be used in these Listed medicines, provided they meet the conditions set by the TGA. This allows manufacturers and suppliers to include this substance in their products, provided they comply with all other regulatory requirements. The Act imposes obligations on the parties and entities it governs to ensure that therapeutic goods, including those containing concentrated omega-3 triglycerides-fish, meet safety, quality and efficacy standards. Manufacturers and suppliers must ensure that their products comply with the requirements of the ARTG and the Act. This includes adhering to the specified conditions for the use of concentrated omega-3 triglycerides-fish in Listed medicines, as well as ensuring that all other ingredients and claims are approved and compliant. Failure to comply with these obligations can result in legal consequences. Any breach of the requirements set forth in the Act, including those related to the use of concentrated omega-3 triglycerides-fish in Listed medicines, may result in civil or criminal penalties. The Act provides for penalties for offences, including fines and imprisonment, depending on the severity of the breach. While the specific penalties for breach of the Listing Notice are not detailed in the Explanatory Statement, it is clear that non-compliance with the Act's provisions could lead to significant consequences for the parties involved. The Therapeutic Goods Regulations 1990 further outline the regulatory framework and enforcement mechanisms that apply to these provisions.