COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On 19 November 2014, the delegate of the Secretary of the Department of Health for the purposes of sections 14, 14A and 15 of the Therapeutic Goods Act 1989 (“the Act”), on the application of SC Johnson & Son Pty Ltd, gave consent to:
- the supply of S.C. Johnson Disinfectants, without claims non-sterile 'Quaternary Ammonium Compounds', listed under ARTG 62416 that do not conform with the requirements of paragraph 3(5)(A) of Therapeutic Goods Order No. 54 — Standard for Disinfectants and Sterilants, in that the products have not met the requirements of the AOAC Hard surface carrier test.
The consent applies to the following batches:
- Duck 5 in 1 - Lavender (batch numbers 616499, 577581, 5778285, 578354);
- Duck 5 in 1 - Lime splash (batch numbers 616501, 577193, 578284, 578283, 578356, 578357);
- Duck 5 in 1 - Spring petals (batch number 616502); and
- Duck 5 in 1 - Fresh Pine 650ml (batch numbers 616504, 577492, 578359),
but only until 31 December 2014.
(Signed by)
Andrea Kunca
Delegate of the Secretary
Head, Office of Devices Authorisation
Therapeutic Goods Administration
19 November 2014
Overview
The Therapeutic Goods Act 1989 was enacted by the Parliament of Australia to regulate the supply of therapeutic goods within the country. This legislation was introduced to address the need for a comprehensive framework governing the quality, safety, efficacy, and timely availability of therapeutic goods, which include medicines, medical devices, and other health-related products. The Act provides mechanisms to ensure that these products meet appropriate standards and that their benefits outweigh any potential risks. This particular notice, issued under sections 14 and 14A of the Act, was intended to address a specific gap concerning the non-compliance of certain disinfectant products with established standards. The policy objective here is to permit the supply of these products temporarily under certain conditions, while ensuring that consumer safety and public health are not compromised. The notice was issued by the delegate of the Secretary of the Department of Health, Andrea Kunca, who acts on behalf of the Therapeutic Goods Administration to facilitate compliance with the Act.
Scope and Application
The Therapeutic Goods Act 1989 applies to entities and persons involved in the supply, import, export, or manufacture of therapeutic goods in Australia. The Act covers a broad range of therapeutic goods, including medicines, medical devices, blood, and tissues, and regulates their quality, safety, and efficacy. The jurisdictional reach of the Act is national, with the Therapeutic Goods Administration (TGA) as the federal regulator overseeing compliance. The Act extends its application through various Therapeutic Goods Orders and Regulations, which provide further detail on specific therapeutic goods and their requirements. The consent granted to SC Johnson & Son Pty Ltd under sections 14 and 14A of the Act is specific to the supply of certain batches of 'Quaternary Ammonium Compounds' disinfectants that do not conform to the standard set out in Therapeutic Goods Order No. 54. This consent is limited to the specified batches and is effective only until 31 December 2014, highlighting the Act's capacity to allow for temporary exceptions under stringent regulatory oversight.
Key Provisions
The Therapeutic Goods Act 1989 (the Act) includes specific sections that govern the regulation of therapeutic goods, including disinfectants. Under section 14, the Act provides for the issuance of consent notices that allow certain therapeutic goods to be supplied even if they do not fully comply with the specified standards. In this case, the delegate of the Secretary of the Department of Health has issued a notice under sections 14 and 14A (paragraph 14(1)(a)) that permits SC Johnson & Son Pty Ltd to supply certain disinfectant products that do not meet the AOAC Hard surface carrier test requirements. This consent applies to specific batches of Duck 5 in 1 products, which are listed under ARTG 62416, and it is valid until 31 December 2014 (section 14A(1)(a)). These products include Duck 5 in 1 Lavender, Lime Splash, Spring Petals, and Fresh Pine 650ml.
The Act imposes certain obligations on the parties involved. The manufacturer, SC Johnson & Son Pty Ltd, must ensure that the specified products are supplied only as permitted under the notice, and that they comply with all other relevant provisions of the Act and associated regulations. This includes ensuring that the products are labelled accurately and do not make any claims that could mislead consumers about their safety or efficacy. Additionally, the manufacturer must maintain records that demonstrate compliance with the consent conditions and be prepared to provide these records to the Therapeutic Goods Administration upon request.
Failure to comply with the provisions of the Therapeutic Goods Act 1989 or the conditions of the consent notice can result in serious legal consequences. Under section 36 of the Act, the delegate may issue an infringement notice for an offence related to the supply of therapeutic goods that do not comply with the Act, with a maximum penalty of $22,200 for a corporation. Additionally, more serious breaches can lead to criminal charges under section 33, which can result in penalties of up to $1,110,000 for a corporation and imprisonment for up to 10 years. Civil penalties may also be applicable under section 123, where a person may be liable for damages for any loss or damage caused by the supply of non-compliant goods. The Therapeutic Goods Administration retains the right to take enforcement actions, including product recalls and legal proceedings, to ensure compliance with the Act.