Publication of List of Manufacturers Granted Licence for the Manufacture of Therapeutic Goods - Organic Care Pharmaceutical Pty Ltd - BMDI Cord Blood Bank - The Australian Red Cross Blood Service

Overview

The Therapeutic Goods Act 1989 was enacted to regulate the supply of therapeutic goods in Australia, ensuring they are safe, of high quality, and effective. This legislation was introduced to address the need for stringent control over the manufacturing, supply, and advertising of therapeutic goods to protect public health. The Act is administered by the Therapeutic Goods Administration, an agency of the Australian Government's Department of Health. The primary policy objective of the Act is to safeguard the health and safety of Australians by ensuring that therapeutic goods available in the market meet the necessary standards and are used appropriately. This is achieved by requiring manufacturers and suppliers to obtain licences and adhering to specific regulatory requirements. This gazette serves as a public notice of licences granted to specific entities to manufacture therapeutic goods, reflecting the ongoing commitment to transparency and accountability in the regulation of therapeutic goods in Australia. The Therapeutic Goods Administration, through this publication, ensures that the public and industry stakeholders are informed about entities authorised to manufacture therapeutic goods, thereby maintaining the integrity of the regulatory framework established under the Act.

Scope and Application

The Therapeutic Goods Act 1989, administered by the Therapeutic Goods Administration under the Department of Health, applies to entities engaged in the manufacture, supply, and advertising of therapeutic goods in Australia. Specifically, the Act regulates the quality, safety, and efficacy of therapeutic goods, which encompass a wide range of products including medicines, medical devices, blood, and tissues. The legislation applies to manufacturers, importers, and sponsors of these goods, ensuring they meet stringent standards before they are made available in the market. The geographic reach of the Act is national, applying across all states and territories within Australia. Notably, the Act extends its application through various subordinate instruments that provide detailed guidelines and standards for compliance. Exclusions and exemptions may apply to certain goods, such as those that are considered low-risk or used solely for research purposes, but these are specifically outlined in the Act or its subsidiary regulations. This legislative framework is designed to protect public health by ensuring that only safe and effective therapeutic goods are available for use in Australia.

Key Provisions

The Therapeutic Goods Act 1989 includes a provision (Section 38) that allows the Secretary to grant a licence to manufacturers of therapeutic goods. In the case of the Gazette C2015G00526, the Secretary has granted licences to three entities: Organic Care Pharmaceutical Pty Ltd, BMDI Cord Blood Bank, and The Australian Red Cross Blood Service. Each of these entities has been granted a specific licence number and details of their operations have been published. Organic Care Pharmaceutical Pty Ltd has been granted Licence No. MI-2013-LI-03166-1 and operates out of 2/17 Artisan Road, SEVEN HILLS, NSW, 2147. BMDI Cord Blood Bank has been granted Licence No. MI-2014-LI-08608-1 and operates out of Building A Arnold Street, BOX HILL, VIC, 3128. The Australian Red Cross Blood Service, an operating division of The Australian Red Cross Society, has been granted Licence No. MI-2015-LI-00513-1 and operates out of Blood Donor Centre Newcastle Suite 1 Ground Floor 165 Lambton Road, BROADMEADOW, NSW, 2292. The grant of these licences imposes specific obligations on the licensees. These include, but are not limited to, maintaining records of their manufacturing processes and ensuring that their operations comply with the standards set out in the Therapeutic Goods Act 1989 and any associated regulations. The licensees must also ensure that any therapeutic goods they manufacture are of an acceptable quality and are safe for use by consumers. Failure to meet these obligations can result in the Secretary cancelling or suspending the licence, which would prevent the licensee from continuing to manufacture therapeutic goods. The Therapeutic Goods Act 1989 also sets out various offences and penalties for breaches of the Act and associated regulations. Offences can include manufacturing or supplying therapeutic goods that do not comply with the Act or that are unsafe for use by consumers. The maximum penalties for these offences can vary depending on the nature and severity of the offence. For example, an individual who is found guilty of an offence that results in the death or serious injury of a consumer can be imprisoned for up to 10 years or fined up to $66,000 or both. Corporations can be fined up to $330,000 for similar offences. It is important to note that these penalties are in addition to any civil or criminal consequences that may arise from a breach of the Act or associated regulations.