Consent given pursuant to sections 14 and 14A for the importation and supply of the therapeutic goods specified - between 15 December 2014 and 16 December 2017

Overview

The Therapeutic Goods Act 1989, enacted by the Commonwealth Parliament, aims to ensure the safety, quality, and efficacy of therapeutic goods in Australia, including medicines, medical devices, and blood products. The Act was introduced to address the need for a comprehensive regulatory framework governing the therapeutic goods market, ensuring public health and safety. In 2014, the delegate of the Secretary of the Department of Health, pursuant to the Act, granted consent for Bayer Australia Ltd to import and supply certain products with labels that do not conform to the requirements of the Therapeutic Goods Order No. 69, provided specific conditions are met. This decision reflects the policy objective of balancing regulatory compliance with the practicalities of market transitions, facilitating continuity of supply for consumers while maintaining oversight of therapeutic goods.

Scope and Application

The Therapeutic Goods Act 1989, as amended, governs the regulation of therapeutic goods in Australia, including medicines, medical devices, and other related products. This Act applies to all persons and entities involved in the importation, manufacture, supply, and advertising of therapeutic goods within Australia. It encompasses a broad range of therapeutic goods and their associated activities, including the labelling, packaging, and distribution of these goods. The Act applies across the Commonwealth, ensuring a consistent regulatory approach to therapeutic goods across the nation. However, the Act does not apply to therapeutic goods that are exempt under the Therapeutic Goods (Exemptions) Order, such as certain blood products and devices used for personal purposes. The Therapeutic Goods Regulations 2008 provide additional detail and further extend the application of the Act through various provisions, including those concerning advertising, labelling, and the quality and safety of therapeutic goods.

Key Provisions

The Therapeutic Goods Act 1989 (the "Act") includes provisions that allow for the consent of the Secretary of the Department of Health to import and supply therapeutic goods that do not conform to certain regulations. Specifically, section 14 and 14A of the Act allow the Secretary, on the application of a party, to grant consent for the importation and supply of therapeutic goods that do not meet the requirements of certain therapeutic goods orders. In this case, the consent granted by the delegate of the Secretary (paragraph 1) allows Bayer Australia Ltd to import and supply specified products that do not conform to the labelling requirements under TGO 69. This consent is effective from 15 December 2014 until 16 December 2017. Under the Act, the obligations of Bayer Australia Ltd, as the party granted the consent, include ensuring that the labels of the specified products display the name and address of the current sponsor or supplier, rather than the previous sponsor's information, as per the condition of the consent (paragraph 2). Additionally, Bayer Australia Ltd must have arrangements in place to redirect any queries or complaints concerning the products to them. This ensures that consumers and healthcare providers have accurate information about the products and can contact Bayer Australia Ltd for any concerns or questions. Breaches of the conditions of consent granted under section 14 and 14A of the Act may result in both civil and criminal penalties. The Act does not specify maximum penalties for breaches of consent conditions, but it is subject to the general penalties for breaches of the Act, which can include fines and imprisonment. The specific penalties for a breach would depend on the nature and extent of the breach, as well as any relevant circumstances. It is important for Bayer Australia Ltd to comply with the conditions of the consent to avoid potential legal consequences.