Consent given pursuant to sections 14 and 14A for the supply and importation of the Therapeutic Goods specified - between 1 October 2014 and 30 September 2015

Overview

The Therapeutic Goods Act 1989, enacted by the Parliament of Australia, was introduced to regulate the importation, supply, and monitoring of therapeutic goods to ensure they are of acceptable quality and pose no unacceptable risks to health or safety. The Act was established to fill the gap in regulating therapeutic goods comprehensively and to provide a clear framework for the control and quality assurance of these products. The Therapeutic Goods Administration, under the Department of Health, administers the Act and is responsible for ensuring compliance with its provisions. The policy objective of the Act is to protect public health by ensuring that therapeutic goods are safe, of high quality, and effective, while facilitating access to these goods. In 2014, the Therapeutic Goods Administration granted consent under section 14 and 14A of the Act for the importation and supply of tamsulosin hydrochloride, a medicine used to treat certain prostate conditions. This consent was issued by the delegate of the Secretary of the Department of Health for Astellas Pharma Australia Pty Ltd. The consent allowed for the importation and supply of the medicine despite it not fully conforming to the labelling requirements, provided that the labels previously approved for the former sponsor, CSL Limited, were used, and that arrangements were made to redirect any queries or complaints to Astellas Pharma Australia Pty Ltd. This consent was effective from October 1, 2014, until September 30, 2015, demonstrating the flexibility of the Act to accommodate specific circumstances while maintaining its overarching goal of ensuring public health protection.

Scope and Application

The Therapeutic Goods Act 1989 applies to therapeutic goods, including medicines, medical devices, and blood and blood components, within Australia. This Act governs the regulation of these goods from manufacturing, importation, supply, and advertising, to ensure their safety, quality, and efficacy. The Therapeutic Goods Administration (TGA), which operates under the Department of Health, administers and enforces the Act. The legislation extends to the entire Commonwealth of Australia and applies to any person or entity involved in the supply of therapeutic goods, including manufacturers, importers, and suppliers. The Act also extends to the activities and transactions related to therapeutic goods, ensuring they meet the necessary standards and regulations. Notably, the Act does not apply to goods that are exempt under the Therapeutic Goods Order or other related instruments. The application of the Act can be extended or restricted through subordinate instruments such as regulations and orders, which provide more detailed requirements and specific exclusions. In the case of Astellas Pharma Australia Pty Ltd, the TGA granted consent for the importation and supply of a specific batch of tamsulosin hydrochloride, subject to certain conditions, demonstrating the Act’s flexibility in addressing specific circumstances while maintaining overarching regulatory standards.

Key Provisions

Under the Therapeutic Goods Act 1989, sections 14 and 14A allow the Secretary of the Department of Health to provide consent for the importation and supply of therapeutic goods that do not fully conform with certain regulatory requirements. In this case, section 14 consent was granted for the importation and supply of tamsulosin hydrochloride (FLOMAXTRA) 400 microgram prolonged release tablet blister pack [AUST R 115534] by Astellas Pharma Australia Pty Ltd. This consent was provided because the carton labels for the product did not conform with the requirements of subsection 3(2)(l) of Therapeutic Goods Order No. 69, which pertains to the general requirements for labels for medicines, specifically mentioning the inclusion of the previous sponsor's contact details. The obligations imposed by this consent include the use of labels previously approved for the former sponsor, CSL Limited, and the establishment of arrangements with CSL to redirect any queries or complaints about the product to Astellas Pharma Australia Pty Ltd. These conditions ensure that any consumer concerns or inquiries are appropriately handled despite the non-conformity of the labels. Failure to comply with the terms and conditions of this consent can lead to enforcement actions under the Therapeutic Goods Act 1989. Any breach of the specified conditions may result in penalties, which could include fines or other legal consequences. The exact penalties depend on the nature and severity of the breach, but they are designed to ensure that therapeutic goods are supplied in a manner that maintains public health and safety standards.