THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On July 2, 2013 the delegate of the Secretary of the Department of Health and Ageing for the purposes of subsection 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”) gave his consent to:
(a) the supply of the product ciprofloxacin (DBL CIPROFLOXACIN) 200 mg / 100 mL injection for intravenous infusion bag [Aust R 123041], by Hospira Australia Pty Ltd, Melbourne, VIC (“the Company”);
That does not conform with paragraphs 3(2)(l) of Therapeutic Goods Order (TGO) 69, in that the labels state the former sponsors address instead of the current sponsor address.
Pursuant to subsection 15(1) of the Act, the consent given by the delegate of the Secretary as described above is subject to the following conditions:
- The consent applies only to batch numbers M13-1001A, M13-1001B and M13-1001C.
- The label used is that provided with the letter of application, having the old sponsor details.
- No other changes have been made to the product ciprofloxacin (DBL CIPROFLOXACIN) 200 mg / 100 mL injection for intravenous infusion bag [Aust R 123041].
4. Arrangements are in place to promptly redirect all written queries and complaints about the product sent to the old address to the current address.
Overview
The Therapeutic Goods Act 1989 was enacted to regulate the supply of therapeutic goods in Australia, ensuring their safety, quality, and efficacy. This legislation was introduced to address the need for a comprehensive legal framework governing the approval, advertising, and distribution of therapeutic goods, including medicines, medical devices, and blood products. The Act was enacted by the Parliament of Australia and its primary policy objective is to protect public health by ensuring that therapeutic goods available in Australia meet necessary standards. On 2 July 2013, the delegate of the Secretary of the Department of Health and Ageing gave consent for the supply of a specific product, ciprofloxacin, under certain conditions due to a discrepancy in the labelling that failed to reflect the current sponsor's address. This action was taken to ensure compliance with Therapeutic Goods Order 69 while allowing for the necessary transition in sponsorship details.
Scope and Application
The Therapeutic Goods Act 1989 applies to the regulation and control of therapeutic goods in Australia, encompassing various aspects such as the importation, supply, and advertising of therapeutic goods, including medicines, medical devices, and blood. The Act extends its reach across the entire Commonwealth of Australia, setting out the legal framework within which entities and individuals must operate when dealing with therapeutic goods. The consent provided by the delegate of the Secretary pertains to specific batches of the product ciprofloxacin (DBL CIPROFLOXACIN) 200 mg / 100 mL injection for intravenous infusion bag [Aust R 123041] supplied by Hospira Australia Pty Ltd. This consent is subject to certain conditions, such as the application of specific labels and the redirection of written queries and complaints to the current sponsor's address. The consent is limited to batch numbers M13-1001A, M13-1001B, and M13-1001C, and it is important to note that no other changes have been made to the product apart from the label issue. The Act's application may be further refined or expanded through subordinate instruments, which can detail additional requirements or exemptions.
Key Provisions
The Therapeutic Goods Act 1989 (the Act) outlines various provisions for the regulation of therapeutic goods in Australia. Sections 14 and 14A specifically pertain to the consent required for the supply of certain therapeutic goods. In this instance, on July 2, 2013, the delegate of the Secretary of the Department of Health and Ageing consented to the supply of a specific product, ciprofloxacin (DBL CIPROFLOXACIN) 200 mg / 100 mL injection for intravenous infusion bag [Aust R 123041], by Hospira Australia Pty Ltd (section 14(1)). However, this consent comes with certain conditions, particularly regarding the labelling of the product.
The product in question does not conform to the Therapeutic Goods Order (TGO) 69, specifically paragraph 3(2)(l), because the labels bear the former sponsor's address instead of the current sponsor's address (section 14A). Despite this non-compliance, the consent provided is subject to specific conditions. Firstly, the consent only applies to batch numbers M13-1001A, M13-1001B, and M13-1001C (subsection 15(1)). The product supplied will use the label provided with the application letter, which contains the former sponsor's details. Importantly, no other changes have been made to the product itself.
In terms of obligations, the supplier must ensure that all written queries and complaints about the product are promptly redirected from the former sponsor's address to the current sponsor's address. This requirement is aimed at maintaining transparency and ensuring that the sponsor can adequately respond to any issues or concerns related to the product. Failure to comply with the conditions set forth in the consent or the obligations of the Act could result in legal repercussions.
Under the Act, breaches of its provisions or the conditions set by the Secretary may lead to various consequences. While the specific penalties are not detailed in the notice, the Act generally provides for both civil and criminal penalties for non-compliance. Civil penalties can include fines, while criminal penalties can result in imprisonment. The severity of these penalties depends on the nature and extent of the breach, with maximum penalties often outlined in the relevant sections of the Act or associated regulations. It is essential for parties governed by the Act to adhere strictly to its provisions and any conditions imposed to avoid these potential consequences.