Supply of products by AbbVie Pty Ltd

Overview

The Therapeutic Goods Act 1989, enacted by the Parliament of Australia, is designed to regulate the provision of therapeutic goods in Australia. The Act establishes a regulatory framework to ensure that therapeutic goods available in Australia are of an acceptable quality, have benefits that outweigh any risks, and are appropriately advertised. The Act was introduced to address the need for a comprehensive regulatory system to manage the safety, efficacy and quality of therapeutic goods, including medicines, medical devices, blood and tissues. On September 7, 2012, the delegate of the Secretary of the Department of Health and Ageing granted consent for AbbVie Pty Ltd to supply specific products that did not conform with certain labelling requirements, under conditions outlined in the Act, to ensure consumer safety and appropriate oversight of the therapeutic goods market.

Scope and Application

The Therapeutic Goods Act 1989 (the Act) pertains to the regulation of therapeutic goods in Australia, with a focus on ensuring their safety, quality, and efficacy. Section 14 and 14A of the Act authorise the delegate of the Secretary of the Department of Health and Ageing to consent to the supply of therapeutic goods that do not conform with certain regulatory requirements. This specific instance involves AbbVie Pty Ltd, located in Botany, NSW, which has been granted consent to supply several listed products despite their non-compliance with paragraph 3(2)(l) of Therapeutic Goods Order (TGO) 69 due to the outdated sponsor name on the labels. The consent is subject to specific conditions, including a two-year validity period, the use of labels as submitted by the company, and the assurance of continuous customer contact. The consent extends to the products listed in the notification, and no other changes have been made to the products themselves. The scope of the Act applies nationally, covering entities like AbbVie Pty Ltd involved in the supply of therapeutic goods within Australia, ensuring compliance with overarching health regulations.

Key Provisions

The Therapeutic Goods Act 1989 (the "Act") contains various provisions that govern the supply and regulation of therapeutic goods in Australia. In particular, sections 14 and 14A of the Act pertain to the approval process for the supply of therapeutic goods that do not comply with certain legislative standards or requirements. Section 14(1) allows the Secretary, or a delegate, to give consent for the supply of such goods, while section 14A imposes conditions on the consent granted. In this instance, the delegate of the Secretary of the Department of Health and Ageing provided consent for the supply of specific products by AbbVie Pty Ltd, subject to certain conditions. The products listed in the consent include various formulations and presentations of Leuprorelin acetate, Levodopa/carbidopa, Levobupivacaine, Isoflurane, and Sevoflurane. These products do not conform with certain labelling requirements outlined in Therapeutic Goods Order (TGO) 69, specifically the previous sponsor's name being listed on the labels instead of the new sponsor's name (AbbVie). The consent granted by the delegate is subject to several conditions, which include the use of specific labels as submitted by AbbVie, a two-year duration of consent from the date of the consent, and no other changes to the products listed. The obligations imposed by the Act on the parties or entities it governs are significant. AbbVie Pty Ltd, as the entity seeking consent to supply the non-compliant products, must ensure that the products supplied adhere to the conditions outlined in the consent. This includes using the specified labels and maintaining continuous customer contact, as outlined in the correspondence from AbbVie dated August 16 2012. Additionally, AbbVie must ensure compliance with the Therapeutic Goods Act 1989 and relevant regulations and orders throughout the supply of the products. Failure to comply with the conditions imposed by the Therapeutic Goods Act 1989 or the consent granted by the delegate of the Secretary may result in civil or criminal penalties. Under section 34(1) of the Act, an offence is committed if a person contravenes or fails to comply with any provision of the Act or any regulation or order made under the Act. The maximum penalties for contravening the Act or relevant regulations and orders include fines of up to $1,650,000 for a corporation and/or imprisonment for up to 10 years for individuals. These penalties reflect the importance of compliance with the Therapeutic Goods Act 1989 and the potential consequences of non-compliance.