Publication of List of Manufacturers Revoked from Licensing for the Manufacture of Therapeutic Goods - Coral Moon International Pty Ltd

Overview

The Therapeutic Goods Act 1989 was enacted to ensure the safety, quality, and efficacy of therapeutic goods available in Australia. This Act provides a regulatory framework for the manufacture, import, supply, and advertising of therapeutic goods, including medicines, medical devices, and blood products. One of the mechanisms through which the Act seeks to maintain high standards in the therapeutic goods market is by allowing the Secretary of the Department of Health and Ageing, through the Therapeutic Goods Administration, to revoke licences for the manufacture of therapeutic goods. This particular revocation of a licence, published on 23 January 2013 by Bill Turner, acting as the delegate for the Secretary, was issued under the authority of section 41 of the Act. The revocation of Coral Moon International Pty Ltd's licence, number 73458, located at the corner of Rene Street and Bartlett Road, Noosaville, Queensland, was conducted in accordance with the Act's provisions, specifically paragraph 41(1)(d), and was executed at the request of the manufacturer themselves. The Act aims to protect public health by ensuring that only those entities meeting stringent regulatory standards are permitted to manufacture therapeutic goods.

Scope and Application

The Therapeutic Goods Act 1989 applies to entities involved in the manufacture, supply, and advertising of therapeutic goods within Australia. This legislation encompasses a broad range of products, including medicines, medical devices, blood, and tissues. The Act applies to individuals, companies, and other entities that are engaged in activities relating to therapeutic goods, ensuring that these goods meet safety, quality, and efficacy standards. Geographically, the Act operates under the Commonwealth jurisdiction, meaning it applies across the entire country, including states and territories, ensuring a uniform regulatory framework for therapeutic goods. The Act includes provisions for the licensing of manufacturers, and these licences can be revoked under certain circumstances, as evidenced by the revocation of Coral Moon International Pty Ltd's licence. While the Act broadly applies to all manufacturers of therapeutic goods, specific exclusions or exemptions may be detailed in subordinate instruments or specific provisions of the Act, which can tailor its application to certain entities or types of goods based on their risk profile or other regulatory considerations.

Key Provisions

The Therapeutic Goods Act 1989 (the Act) provides the framework for regulating therapeutic goods in Australia, ensuring their safety, quality, and efficacy. Under section 41(1)(d), the Secretary has the authority to revoke a licence to manufacture therapeutic goods. In this instance, the Secretary has revoked the licence held by Coral Moon International Pty Ltd, Licence No. 73458, which is located at the corner of Rene Street and Bartlett Road, Noosaville, Queensland. This revocation occurred following a written request from the manufacturer themselves, as indicated in the document. The Act imposes certain obligations on manufacturers of therapeutic goods, including maintaining high standards of quality and safety. Licence holders are required to comply with all regulations and guidelines set forth by the Therapeutic Goods Administration (TGA). These obligations include ensuring that the therapeutic goods they manufacture meet the necessary standards and that they maintain proper records and documentation. In the case of Coral Moon International Pty Ltd, they were required to adhere to these standards until the revocation of their licence. Failure to comply with the provisions of the Therapeutic Goods Act can result in various consequences. Under the Act, there are both civil and criminal penalties for breaches. Civil penalties can include fines, and in severe cases, criminal penalties may be imposed, including imprisonment. The specific penalties depend on the nature and severity of the breach. In this particular case, the revocation of the licence is the consequence of Coral Moon International Pty Ltd's compliance with the request to revoke, thus avoiding potential penalties. The revocation of the licence by Coral Moon International Pty Ltd signifies the end of their authority to manufacture therapeutic goods. This action ensures that the company no longer poses a risk to public health by manufacturing goods that may not meet the required safety and quality standards. It is a clear demonstration of the TGA's commitment to protecting the health and safety of the Australian public by enforcing the provisions of the Therapeutic Goods Act.