Therapeutic Goods (Listing) Notice 2007 (No. 2)

Overview

The Therapeutic Goods (Listing) Notice 2007 (No. 2) was enacted to address a gap in the regulatory framework concerning the use of Glycerol as an active ingredient in Listed complementary medicines for topical use. This Notice was issued under subsection 9A(5) of the Therapeutic Goods Act 1989 by the delegate of the Minister for Health and Ageing. The primary objective of the Act is to establish and maintain a national system of controls ensuring the quality, safety, efficacy, and timely availability of therapeutic goods in Australia or exported from Australia. The Therapeutic Goods Administration (TGA) is tasked with administering this Act, requiring therapeutic goods to be included in the Australian Register of Therapeutic Goods (ARTG) unless exempted. The Notice specifically aims to facilitate the inclusion of Glycerol as an active ingredient in Listed medicines, aligning with the TGA's approval of low-risk substances and certain therapeutic claims for Listed medicines.

Scope and Application

The Therapeutic Goods (Listing) Notice 2007 (No. 2) applies to the use of glycerol as an active ingredient in listed complementary medicines for topical use in Australia. This Notice is made by the delegate of the Minister for Health and Ageing under subsection 9A(5) of the Therapeutic Goods Act 1989. The Act establishes and maintains a national system for the control of the quality, safety, efficacy, and timely availability of therapeutic goods used or exported from Australia, with the Therapeutic Goods Administration (TGA) responsible for administering the Act. Therapeutic goods must be included in the Australian Register of Therapeutic Goods (ARTG) unless exempted under the Act. Glycerol, previously permitted only as an uncompounded medicine substance, is now approved for use as an active ingredient in listed medicines subject to the conditions specified in the Notice. This regulatory change is minor and machinery in nature, with no consultation or Regulation Impact Statement required. The Notice commences on the day after its registration on the Federal Register of Legislative Instruments and remains in effect until Schedule 4 of the Therapeutic Goods Regulations 1990 is amended to include glycerol as a permitted substance in listed medicines.

Key Provisions

The Therapeutic Goods (Listing) Notice 2007 (No. 2) (the Listing Notice) under section 9A(5) of the Therapeutic Goods Act 1989 (the Act) allows for the use of Glycerol as an active ingredient in Listed complementary medicines for topical use. This means that Glycerol can now be included in products such as creams, ointments, and lotions that are classified as complementary medicines in Australia. This Notice came into effect on the day after it was registered on the Federal Register of Legislative Instruments. Under the Act, therapeutic goods must be included in the Australian Register of Therapeutic Goods (ARTG) before they can be supplied in, imported into, manufactured in, or exported from Australia (section 19B and 19C of the Act). Medicines are either Registered or Listed in the ARTG based on their ingredients and the therapeutic claims made. Complementary medicines, which include vitamins, minerals, nutritional supplements, and various alternative therapies, are generally Listed in the ARTG due to their perceived lower risk compared to prescription and over-the-counter medicines. Listed medicines can only contain ingredients approved by the Therapeutic Goods Administration (TGA) as low-risk and can only make certain therapeutic claims. The Listing Notice imposes an obligation on the parties involved to ensure that Glycerol, when used as an active ingredient in Listed complementary medicines, complies with the conditions specified in the Notice. This includes ensuring that any products containing Glycerol as an active ingredient are appropriately Listed in the ARTG and adhere to the regulations governing Listed medicines. The Therapeutic Goods Regulations 1990 (the Regulations) further outline the requirements for Listed medicines. Schedule 4 of the Regulations specifies the therapeutic goods that must be included in the ARTG for Listed medicines. When Glycerol is mentioned in Schedule 4 following an amendment, the Listing Notice ceases to have effect (subsection 9A(6) of the Act). Currently, Glycerol is permitted only as an uncompounded medicine substance (under Item 8, Part 1, Schedule 4 of the Therapeutic Goods Regulations 1990) and is not generally approved as an active ingredient in Listed medicines. The Listing Notice changes this by allowing Glycerol to be used in Listed complementary medicines for topical application. Breaches of the requirements under the Act and Regulations may lead to various consequences, including administrative penalties for failing to list a therapeutic good in the ARTG or for making false or misleading statements. The Therapeutic Goods Act 1989 provides for both civil and criminal penalties for such breaches, including fines up to $22,200 for individuals and $111,000 for bodies corporate, depending on the severity and nature of the offence. These penalties underscore the importance of compliance with the legislative and regulatory framework governing therapeutic goods in Australia.