Consent given pursuant to Sections 14 and 14A to the supply of the therapeutic goods specified by Symbion Pty Ltd

Overview

The Therapeutic Goods Act 1989 was enacted by the Parliament of Australia to regulate the supply of therapeutic goods within Australia, ensuring that these products are safe, of high quality, and have the expected benefits. This Act was introduced to address the need for a comprehensive regulatory framework to govern the import, export, manufacture, and distribution of therapeutic goods, including medicines, medical devices, and blood products. The Therapeutic Goods Administration, a part of the Department of Health, administers the Act to safeguard public health by ensuring that therapeutic goods meet necessary standards. The policy objective of the Act is to protect and enhance public health by providing a robust regulatory system that controls the therapeutic goods market in Australia. On 18 December 2015, a delegate of the Secretary of the Department of Health granted consent under sections 14 and 14A of the Therapeutic Goods Act 1989 to Symbion Pty Ltd for the supply of specific batches of certain pharmaceutical products. The consent was issued due to non-compliance with the labelling requirements as outlined in Therapeutic Goods Order No. 69, specifically concerning the inclusion of mandatory advisory statements on the labels. The consent, effective from 18 December 2015 until 12 June 2016, is limited to the batches specified in the notice and is subject to certain conditions, ensuring that the labels used for these products adhere to the previously approved versions.

Scope and Application

The Therapeutic Goods Act 1989 applies to a wide range of therapeutic goods within Australia, including medicines, medical devices, blood and blood components, tissues, and complementary medicines. It governs the regulation and oversight of these products to ensure they are safe, of acceptable quality, and perform as represented. The Act applies to persons and entities involved in the importation, manufacture, supply, and advertising of therapeutic goods in Australia, including manufacturers, suppliers, importers, and distributors. The scope of the Act extends nationally, covering all states and territories within the Commonwealth of Australia. The Act includes specific provisions for exemptions and exclusions, such as for certain goods used for personal or domestic purposes. The application of the Act may be extended or restricted through subordinate instruments, such as Therapeutic Goods Orders, which provide detailed requirements for specific types of therapeutic goods or classes of products. The Therapeutic Goods Administration (TGA) administers the Act and can grant consents to supply non-compliant goods under certain conditions, as demonstrated in the specified case concerning the supply of particular batches of pharmaceutical products with labelling deficiencies.

Key Provisions

Under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act), a delegate of the Secretary of the Department of Health granted consent to Symbion Pty Ltd for the supply of specific batches of certain pharmaceutical products. These products, listed in the table, include various brands and formulations of thrush treatment, aspirin, cough mixture, heartburn relief, and cold relief medications. This consent was issued on 18 December 2015 and was effective until 12 June 2016. The consent allowed for the supply of these products despite their labels not fully complying with the requirements of paragraph 3(2)g of the Therapeutic Goods Order No. 69, specifically not including all required advisory statements as specified in the Medicines Advisory Statements Specification 2014 from 12 December 2015. The consent applies only to the batches specified in the table and is subject to certain conditions, including the use of previously approved labels. The obligations imposed by the Act on Symbion Pty Ltd and the Department of Health include ensuring that the products listed are supplied under the terms of the consent. Symbion Pty Ltd must adhere to the specified conditions, including using the previously approved labels for the products as provided in the request letters dated 7, 8, and 17 December 2015. The Department of Health, through its delegate, must monitor the supply of these products to ensure compliance with the consent terms and conditions, including the timeframe and product specifications. Failure to comply with the conditions of the consent or any other provisions of the Act may result in legal consequences. While the specific penalties for breach are not detailed in the provided extract, the Therapeutic Goods Act generally includes provisions for both civil and criminal penalties for non-compliance. Civil penalties may include fines, while criminal penalties could involve imprisonment, reflecting the seriousness of ensuring the safety and quality of therapeutic goods supplied in Australia. The exact penalties would depend on the specific nature and severity of the breach, as outlined in other sections of the Act.