THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On January 24 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 desogestrel/ethinyloestradiol (MARVELON) 28 tablet blister pack [Aust R 42894], by Merck Sharp & Dohme Australia Pty Ltd, North Ryde NSW, (“the Company”);
That does not conform with paragraph 3(2)(l) of Therapeutic Goods Order (TGO) 69, in that the details of the previous sponsor (Schering-Plough) are listed on the blister foil and carton labels, instead of those of the Company.
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 to supply applies to batches 156152 and 102240 of the tablets.
2. The labels to which this consent applies are identical to those currently used, having the previous sponsor details.
3. No other changes have been made to the product desogestrel/ethinyloestradiol (MARVELON) 28 tablet blister pack [Aust R 42894].
4. Arrangements are in place to ensure complaints or queries concerning this product will be dealt with promptly.
Overview
The Therapeutic Goods Act 1989, enacted by the Parliament of Australia, aims to regulate the supply of therapeutic goods within the country, ensuring their safety, quality, and efficacy. The 2013 Gazette notice under Sections 14 and 14A of the Act addresses a specific issue concerning the supply of desogestrel/ethinyloestradiol (MARVELON) 28 tablet blister packs by Merck Sharp & Dohme Australia Pty Ltd. The problem identified in this case involves non-compliance with Therapeutic Goods Order (TGO) 69, where the previous sponsor's details were listed on the blister foil and carton labels instead of those of the current supplier. The delegate of the Secretary of the Department of Health and Ageing provided consent for the supply of these particular batches of the product under certain conditions, ensuring that the labels remain unchanged and that any complaints or queries are promptly addressed. This action underscores the policy objective of maintaining regulatory oversight and consumer protection in the therapeutic goods market.
Scope and Application
The Therapeutic Goods Act 1989 applies to a broad range of entities, including individuals and companies involved in the manufacturing, importation, supply, and advertising of therapeutic goods in Australia. This Act ensures the quality, safety, and efficacy of therapeutic goods available in the Australian market. Specifically, the notice issued under section 14 and 14A of the Act pertains to the supply of the product desogestrel/ethinyloestradiol (MARVELON) 28 tablet blister pack [Aust R 42894] by Merck Sharp & Dohme Australia Pty Ltd. This consent allows the specified batches of the product to be supplied despite not conforming to certain labelling requirements outlined in TGO 69. The consent is contingent upon several conditions, including the use of existing labels with previous sponsor details, no other changes to the product, and arrangements for handling complaints or queries. The geographic and jurisdictional reach of this Act is national, as it governs the therapeutic goods market across all states and territories in Australia. Notably, the application of the Act may be extended or restricted through subordinate instruments, such as the Therapeutic Goods Orders mentioned in the notice.
Key Provisions
The Therapeutic Goods Act 1989, in its sections 14 and 14A, outlines the process for the regulation of therapeutic goods in Australia. Under these sections, the Secretary of the Department of Health and Ageing can delegate the authority to consent to the supply of goods that do not conform to certain standards, subject to specific conditions. In this instance, the delegate has provided consent (section 14) for the supply of desogestrel/ethinyloestradiol (MARVELON) 28 tablet blister packs by Merck Sharp & Dohme Australia Pty Ltd, despite the product not conforming with paragraph 3(2)(l) of Therapeutic Goods Order (TGO) 69, which pertains to the inclusion of the previous sponsor's details on the product labels rather than those of the current supplier.
The Act imposes several obligations on the parties involved. Firstly, the consent granted is conditional, meaning that Merck Sharp & Dohme Australia Pty Ltd must adhere strictly to the conditions outlined. This includes ensuring that the labels of the product remain identical to those currently in use, which still bear the previous sponsor's details (section 15(1)(2)). Additionally, the Act requires that no other changes have been made to the product itself beyond what is stipulated (section 15(1)(3)). Lastly, the company must have arrangements in place to promptly address any complaints or queries regarding the product (section 15(1)(4)).
The Therapeutic Goods Act 1989 also delineates the consequences for non-compliance with the conditions of consent. While specific offences and penalties are not detailed in the notice, breaches of the Act can lead to civil or criminal penalties. Under the general provisions of the Act, those found to be in breach may face fines and, in some cases, imprisonment. The maximum penalties can vary depending on the severity of the breach and are outlined in other sections of the Act. It is important for the company to adhere to the stipulated conditions to avoid any potential legal repercussions.