Supply of tretinoin (STIEVA-A 0.1%) 1 mg/g cream tube by GlaxoSmithKline Australia Pty Ltd

Overview

The Therapeutic Goods Act 1989, enacted to regulate the supply and quality of therapeutic goods in Australia, was introduced to ensure that therapeutic goods available in the country are of high quality and safe for consumers. The Act was established by the Commonwealth Parliament with the primary objective of protecting public health by ensuring that therapeutic goods are of acceptable quality, and their benefits outweigh any risks. In a specific instance under this Act, on October 25, 2012, the delegate of the Secretary of the Department of Health and Ageing granted consent for the supply of the product tretinoin (STIEVA-A 0.1%) 1 mg/g cream tube, manufactured by GlaxoSmithKline Australia Pty Ltd, despite it not fully conforming to certain labelling requirements. This consent was subject to specific conditions to ensure that the product would eventually comply with the Therapeutic Goods Order and maintain the quality and safety standards expected under the Act.

Scope and Application

The Therapeutic Goods Act 1989 applies to the regulation of therapeutic goods, which includes medicines, medical devices, and blood and blood components used in Australia. It applies to entities such as manufacturers, sponsors, and importers who are involved in the supply of therapeutic goods within the country. The Act also applies to the conduct and transactions related to the supply, import, export, advertising, and sponsorship of therapeutic goods. In terms of geographic reach, the Therapeutic Goods Act 1989 applies at the national level, with the Therapeutic Goods Administration (TGA) being the regulatory authority responsible for its implementation across all states and territories of Australia. The Act provides certain exclusions and exemptions, including for products used for personal or domestic purposes, or for research and development. The application of the Act can be extended or restricted through subordinate instruments such as therapeutic goods orders and variations to those orders, which provide specific details on the regulation of therapeutic goods. In this particular case, the consent granted by the delegate of the Secretary for the supply of the product tretinoin (STIEVA-A 0.1%) 1 mg/g cream tube by GlaxoSmithKline Australia Pty Ltd is subject to certain conditions, including the timeframe of supply, the specific labels to which the consent applies, and the requirement for future batches of the product to be in full conformance with the requirements of TGO 69.

Key Provisions

The Therapeutic Goods Act 1989, in sections 14 and 14A, allows the delegate of the Secretary of the Department of Health and Ageing to give consent for the supply of therapeutic goods that do not fully conform to the standards outlined in the Therapeutic Goods Orders. In this instance, section 14(1) of the Act provides that the delegate can consent to the supply of tretinoin (STIEVA-A 0.1%) 1 mg/g cream tube [Aust R 39838], manufactured by GlaxoSmithKline Australia Pty Ltd, which does not comply with the sponsor details requirement in TGO 69. This consent is specifically limited to the 25 g pack size and is valid until the end of February 2013 (Section 15(1)). The consent requires that the labels of the product remain identical to those previously supplied by the Company, which include the sponsor details of the previous sponsor, Stiefel. Under this consent, several obligations are placed on the Company. They must ensure that the product supplied is identical to the samples provided in the correspondence dated August 24, 2012, in terms of labelling. Additionally, the Company is required to promptly redirect any correspondence from customers that is addressed to the previous sponsor, Stiefel, to themselves. Future batches of the product must fully comply with the requirements of TGO 69. Failure to comply with the conditions of this consent could result in legal consequences. While the Therapeutic Goods Act 1989 does not explicitly state penalties for non-compliance in this specific context, general provisions within the Act allow for enforcement actions. These may include fines, product recalls, and other administrative actions. Given the seriousness of supplying non-compliant therapeutic goods, there could also be civil or criminal liability for any harm caused by the non-compliant product. The exact penalties would depend on the nature and extent of the breach, but they could include substantial fines and imprisonment under other sections of the Act.