Supply of OILATUM Plus Concentrated Bath Emollient by GlaxoSmithKline Pty Ltd

Overview

The Therapeutic Goods Act 1989 was enacted to provide a regulatory framework for therapeutic goods, including medicines, medical devices, and blood and blood components, in Australia. This Act was introduced to ensure that therapeutic goods available in Australia are safe, of acceptable quality, and that their benefits outweigh any risks. The Act was enacted by the Australian Parliament, aiming to protect public health by regulating the supply and advertising of therapeutic goods. The Act also seeks to ensure that therapeutic goods are available to the Australian community and that information about these goods is readily accessible. In 2012, a specific consent was issued under sections 14 and 14A of the Therapeutic Goods Act 1989 by Mayada Kayali, a delegate of the Secretary to the Department of Health and Ageing. This consent permitted GlaxoSmithKline Pty Ltd to supply two specific batches of OILATUM Plus Concentrated Bath Emollient that did not fully comply with certain labelling requirements, specifically the inclusion of the current sponsor's name and address on the product label. This exemption was conditional, requiring the label to include the previous sponsor's details, ensuring consumer contact information was directed to the current sponsor, and compliance with all other regulatory standards. This measure aimed to allow continued supply of the product while maintaining consumer protection and regulatory oversight.

Scope and Application

The Therapeutic Goods Act 1989, specifically sections 14, 14A, and 15, governs the regulation of therapeutic goods in Australia, encompassing a wide array of products such as medicines, medical devices, and blood and blood components. This legislation applies to entities and individuals involved in the manufacture, importation, supply, or sponsorship of therapeutic goods, ensuring that such goods meet safety, quality, and efficacy standards. The act extends its jurisdiction across the Commonwealth, applying uniformly to all states and territories in Australia, thereby providing a cohesive regulatory framework nationwide. However, certain exclusions and exemptions may apply depending on the nature of the goods or the specific conditions of supply, and these are often delineated through subordinate instruments or specific authorisations. In this instance, the delegate of the Secretary to the Department of Health and Ageing has issued a consent under sections 14 and 14A for GlaxoSmithKline Pty Ltd to supply specific batches of OILATUM Plus Concentrated Bath Emollient, which does not fully comply with certain labelling requirements. This exemption is tightly controlled, limited to specific batches and subject to conditions that include maintaining the previously approved sponsor's contact details on the label to ensure traceability and consumer information continuity.

Key Provisions

Section 14 and 14A of the Therapeutic Goods Act 1989 (the Act) provide the framework for granting exemptions from certain regulatory requirements for therapeutic goods. In this instance, the delegate of the Secretary to the Department of Health and Ageing has issued a consent (Section 14) for GlaxoSmithKline Pty Ltd to supply OILATUM Plus Concentrated Bath Emollient, which does not comply with a specific labelling requirement under Therapeutic Goods Order No. 69. The exemption is limited to two batches, F1546 and F1547, and requires that the label include the name and address of the previously approved sponsor, Stiefel Laboratories Pty Ltd. Moreover, the current sponsor must ensure that the contact details on the label direct consumers to the current sponsor. Finally, the product must meet all other regulatory standards. The Act imposes several obligations on the parties involved in this consent. Firstly, GlaxoSmithKline Pty Ltd must ensure that the specified batches of OILATUM Plus Concentrated Bath Emollient adhere to the conditions outlined in the consent. This includes updating the label to include the previously approved sponsor’s details and ensuring that these details direct consumers to the current sponsor. Additionally, the company must verify that the product complies with all other relevant therapeutic goods standards and regulations. The delegate of the Secretary retains the right to monitor and enforce compliance with these conditions. Failure to comply with the conditions stipulated in the consent can result in legal consequences. Under the Act, breaches of the terms of the consent may lead to enforcement actions, including fines and other penalties. Although the specific penalties are not detailed in the consent itself, they would typically align with the broader provisions of the Therapeutic Goods Act, which can include substantial financial penalties for non-compliance with regulatory requirements. Furthermore, ongoing non-compliance could result in more severe consequences, such as the suspension or revocation of the therapeutic goods authorisation.