THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On April 22 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 products:
- testosterone (ANDRODERM) 12.2 mg per patch transdermal drug delivery system sachet [Aust R 61818]
- testosterone (ANDRODERM) 24.3 mg per day patch transdermal drug delivery system sachet [Aust R 82398]
- oxybutynin (OXYTROL) 3.9 mg/ day transdermal drug delivery system sachet [Aust R 125489]
by Watson Pharma Pty Ltd South Melbourne, VIC (“the Company”);
That does not conform with paragraphs 3(2)(l) of Therapeutic Goods Order (TGO) 69, in that the details of the previous sponsor (Hospira) are listed on the pouch and carton instead of the new sponsor details.
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:
- This consent applies until the end of August 2013
- The labels to which this consent applies are those previously used by the old sponsor, having Hospira’s details on them.
- No other changes have been made to the products.
- Arrangements are in place for the prompt referral of any complaints or queries concerning the products to be referred to the new sponsor.
Overview
The Therapeutic Goods Act 1989, enacted to regulate the importation, supply, and quality of therapeutic goods in Australia, was amended through the Gazette C2013G00773 on April 22, 2013. This amendment was introduced to address a specific issue regarding the supply of certain transdermal drug delivery systems by Watson Pharma Pty Ltd. These products, namely testosterone (ANDRODERM) and oxybutynin (OXYTROL), did not conform to the requirements of Therapeutic Goods Order (TGO) 69, specifically failing to update the sponsor details on their packaging. The enactment of this amendment by the delegate of the Secretary of the Department of Health and Ageing under the authority of the Therapeutic Goods Act 1989 aimed to ensure that the supply of these therapeutic goods could proceed under certain conditions while maintaining the integrity and safety standards required by Australian regulations.
Scope and Application
The Therapeutic Goods Act 1989, as amended and relevant to the notice given on April 22, 2013, pertains to the regulation of therapeutic goods within Australia. This particular notice concerns the consent given by the delegate of the Secretary of the Department of Health and Ageing to allow Watson Pharma Pty Ltd, based in South Melbourne, Victoria, to supply specific products that do not conform with the Therapeutic Goods Order (TGO) 69. The Act applies to entities involved in the supply of therapeutic goods, which includes companies like Watson Pharma Pty Ltd. This consent is geographically limited to Australia and is applicable until the end of August 2013, with certain conditions attached. The products in question, which include various transdermal drug delivery systems for testosterone and oxybutynin, are subject to the consent due to discrepancies in the sponsor details listed on the packaging. The consent ensures that the labels used for these products will continue to display the details of the previous sponsor, Hospira, and mandates that no other changes have been made to the products. Additionally, the consent is conditional upon the establishment of arrangements for promptly referring any complaints or queries about the products to the new sponsor.
Key Provisions
The Therapeutic Goods Act 1989, specifically under Sections 14 and 14A, outlines provisions regarding the supply of therapeutic goods. In this instance, the delegate of the Secretary of the Department of Health and Ageing has given consent (sections 14 and 14A) for Watson Pharma Pty Ltd to supply certain products that do not fully comply with the Therapeutic Goods Order (TGO) 69. These products include testosterone (ANDRODERM) patches in two different strengths and oxybutynin (OXYTROL) patches. The consent is conditional and pertains to the use of labels that previously belonged to the former sponsor, Hospira, which still bear Hospira's details instead of the new sponsor's. This consent is temporary, lasting until the end of August 2013, and stipulates that no other changes have been made to the products (subsection 15(1)).
The obligations imposed by the Act on the parties involved are primarily concerned with ensuring the continued supply of the specified therapeutic goods while maintaining a level of compliance with the TGO 69. Watson Pharma Pty Ltd must use the existing labels with Hospira's details and must not alter any other aspects of the products. Furthermore, they are required to have arrangements in place to ensure that any complaints or queries about the products are promptly referred to the new sponsor. This reflects a commitment to consumer safety and regulatory oversight.
In the event of non-compliance with the conditions set forth in the consent, there could be significant legal ramifications. The Therapeutic Goods Act 1989 does not explicitly state the penalties for breaching the conditions of this consent within the provided text. However, general provisions in the Act suggest that non-compliance could lead to civil or criminal penalties, depending on the severity of the breach. Such penalties may include fines or, in more severe cases, imprisonment. The specific penalties would be determined by a court, taking into account the nature and circumstances of the breach.