THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On April 23 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:
- exenatide (BYETTA 5) 5 mg/20 mL (1.2 mL in total) solution for injection multidose cartridge [Aust R 123609]
- exenatide (BYETTA 10) 10 mg/40 mL (2.4 mL in total) solution for injection multidose cartridge [Aust R 123610]
by AstraZeneca Pty Ltd, North Ryde, NSW (“the Company”);
That does not conform with paragraphs 3(2)(l) of Therapeutic Goods Order (TGO) 69, in that the sponsors details on the labels are those of the previous Company, Eli Lilly Australia, rather than the details the current Company, AstraZeneca Pty Ltd.
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 until the end of December 2013.
2. The labels to which this consent applies are those currently used, having the details of a previous sponsor, Eli Lilly Australia.
3. No other changes have been made to the products listed above.
4. Arrangements are in place for the prompt referral of any queries or complaints concerning the products to the new sponsor, AstraZeneca Pty Ltd.
Overview
The Therapeutic Goods Act 1989 was enacted to regulate the supply of therapeutic goods in Australia, ensuring they meet safety, quality, and efficacy standards. This legislation was introduced to address the need for a comprehensive regulatory framework governing the approval, manufacture, and distribution of therapeutic goods, including medicines, medical devices, and other health-related products. Enacted by the Parliament of Australia, the Act aims to protect public health by ensuring that therapeutic goods available in the market are safe and of high quality. In the context of the 2013 notice, the Department of Health and Ageing provided consent for the supply of certain exenatide products by AstraZeneca Pty Ltd, subject to specific conditions to ensure compliance with labelling requirements. This demonstrates the Act's ongoing role in facilitating the transition of product sponsorship while maintaining rigorous standards for consumer safety and product integrity.
Scope and Application
The Therapeutic Goods Act 1989, as amended, governs the regulation of therapeutic goods in Australia, ensuring that these products meet required safety, quality, and efficacy standards. Under section 14 and 14A, the Act allows the Secretary of the Department of Health and Ageing to grant consent for the supply of therapeutic goods that do not conform with certain legislative requirements. This provision applies to specific products, in this case, exenatide (BYETTA 5) 5 mg/20 mL and exenatide (BYETTA 10) 10 mg/40 mL, manufactured and supplied by AstraZeneca Pty Ltd. The consent given pertains to the supply of these products by the company, which are currently labelled with the details of the previous sponsor, Eli Lilly Australia, instead of the current sponsor, AstraZeneca Pty Ltd. This consent is subject to specific conditions, including the timeframe of its application until the end of December 2013, no further changes to the products, and the establishment of arrangements for handling queries or complaints related to the products. This mechanism ensures that the therapeutic goods in question are supplied under controlled conditions, facilitating a transition in sponsorship while maintaining oversight to safeguard public health.
Key Provisions
Under the Therapeutic Goods Act 1989 (the "Act"), Section 14 and 14A, the delegate of the Secretary of the Department of Health and Ageing has authorised the supply of two specific products: exenatide (BYETTA 5) 5 mg/20 mL (1.2 mL in total) solution for injection multidose cartridge [Aust R 123609] and exenatide (BYETTA 10) 10 mg/40 mL (2.4 mL in total) solution for injection multidose cartridge [Aust R 123610]. These products are to be supplied by AstraZeneca Pty Ltd, North Ryde, NSW, but they do not conform to the Therapeutic Goods Order (TGO) 69, as their labels bear the details of the previous sponsor, Eli Lilly Australia, instead of the current sponsor, AstraZeneca Pty Ltd (Section 14(2)(l) of TGO 69).
The consent given by the delegate of the Secretary is subject to certain conditions outlined in subsection 15(1) of the Act. The consent is effective until the end of December 2013 and applies to the labels currently in use, which contain the details of the previous sponsor, Eli Lilly Australia. Furthermore, no other changes have been made to the products in question. Additionally, there are arrangements in place for the prompt referral of any queries or complaints concerning the products to the new sponsor, AstraZeneca Pty Ltd.
The obligations imposed by this Act on AstraZeneca Pty Ltd include ensuring that the labels used for the products do not mislead consumers by including the details of the previous sponsor. The company must also maintain a system for the prompt referral of any queries or complaints to their office. Failure to comply with these obligations could lead to serious consequences, as outlined in the Act. Specifically, the Act provides for both civil and criminal penalties for breaches, which may include fines and imprisonment. However, the precise penalties are not detailed in the Gazette but would be found in the relevant sections of the Therapeutic Goods Act 1989 or related legislation. The seriousness of the penalty would depend on the nature and extent of the breach, with more severe breaches likely resulting in higher penalties.