Supply of metaraminol (Metaraminol Sandoz) 10 mg/1 ml (as tartrate) injection ampoule by Sandoz Pty Ltd

Overview

The Therapeutic Goods Act 1989, enacted to regulate the supply and advertising of therapeutic goods in Australia, addresses various issues related to the quality, safety, and efficacy of such products. One such instance is addressed in the Gazette notice C2012G00046, issued on August 7, 2012, by the delegate of the Secretary of the Department of Health and Ageing under subsections 14 and 14A of the Act. This notice specifically concerns the supply of the product metaraminol (Metaraminol Sandoz) 10 mg/1 mL (as tartrate) injection ampoule [Aust R 99402] by Sandoz Pty Ltd, which was not conforming to the Therapeutic Goods Order 69 due to outdated address information on its product labels. The delegate’s consent to supply this product is subject to conditions that ensure the issue is promptly addressed, thereby maintaining regulatory compliance and safeguarding public health.

Scope and Application

The Therapeutic Goods Act 1989, specifically sections 14 and 14A, governs the regulation of therapeutic goods in Australia, encompassing a wide range of products from medicines and medical devices to cosmetics and blood. This legislation applies to entities involved in the supply or manufacture of therapeutic goods, including individuals, companies, and other legal entities, and extends to the conduct and transactions associated with the supply of these goods. The Act has a national reach, operating within the Commonwealth of Australia and coordinated through the Department of Health and Ageing. On August 7, 2012, a delegate of the Secretary provided consent under the Act for the supply of a specific product, metaraminol (Metaraminol Sandoz) 10 mg/1 mL injection ampoule, despite the product labels not conforming to certain specifications under the Therapeutic Goods Order 69. This consent, subject to conditions outlined in subsection 15(1) of the Act, is limited to the end of 2012 and pertains solely to the product's labels containing the previous address of the supplier, Sandoz Pty Ltd, with no other modifications to the product. The consent also mandates that procedures must be established to promptly address any inquiries or complaints regarding the product through the updated address.

Key Provisions

The Therapeutic Goods Act 1989 (the Act) governs the regulation of therapeutic goods in Australia, and under sections 14 and 14A, the delegate of the Secretary of the Department of Health and Ageing has the authority to issue consent for the supply of specific therapeutic goods that do not conform to certain standards. In this instance, the delegate has consented to the supply of the product metaraminol (Metaraminol Sandoz) 10 mg/1 mL (as tartrate) injection ampoule [Aust R 99402] by Sandoz Pty Ltd, despite it not conforming with paragraph 3(2)(l) of the Therapeutic Goods Order 69. This non-conformity pertains to the product labels, which currently display the previous address of the Company instead of the current one. However, this consent is conditional and comes with specific requirements that must be adhered to. The primary conditions imposed by the delegate of the Secretary, as outlined in subsection 15(1) of the Act, include the limitation that the consent to supply is effective until the end of 2012. Additionally, the consent pertains only to the currently used labels that contain the old address details. It is crucial that no other changes have been made to the product metaraminol (Metaraminol Sandoz) 10 mg/1 mL (as tartrate) injection ampoule [Aust R 99402]. Furthermore, the Company must ensure that there are procedures in place for the prompt referral of any queries or complaints about the product to the new address. Failure to comply with the conditions set forth by the delegate of the Secretary may lead to various consequences. The Therapeutic Goods Act 1989 includes provisions for both civil and criminal penalties for breaches of its requirements. While the specific penalties are not detailed in the provided text, the Act generally allows for fines and, in more severe cases, imprisonment for offences related to the supply of therapeutic goods that do not meet the required standards. Additionally, the Therapeutic Goods Administration (TGA) has the authority to take enforcement actions, such as issuing warnings, seizing products, or taking legal action against the offending party. It is imperative for Sandoz Pty Ltd to adhere to the stipulated conditions to avoid these potential repercussions.