Publication of list of manufacturers granted licence for the manufacture of therapeutic goods - Nature's Care Manufacture Pty Limited, Capilano Honey Ltd, Clinical Immunology Pathwest Laboratory Medicine Fiona Stanley Hospital

Overview

The Therapeutic Goods Act 1989 was enacted to regulate the quality, safety, and efficacy of therapeutic goods in Australia, addressing the need for a comprehensive legal framework governing these products. The Act was established by the Commonwealth of Australia and is administered by the Therapeutic Goods Administration, an agency of the Department of Health. The primary objective of the Act is to ensure that therapeutic goods available in Australia meet the necessary standards to protect public health. This publication under Section 38 of the Act serves to notify the public of licences granted to manufacturers, thereby maintaining transparency and accountability within the therapeutic goods industry. By providing the details of the licences granted to specific entities, the Act facilitates the oversight of therapeutic goods manufacturing and distribution, ensuring compliance with established regulatory standards.

Scope and Application

The Therapeutic Goods Act 1989 governs the regulation of therapeutic goods in Australia, establishing a comprehensive framework for their approval, registration, and monitoring. The Act applies to various entities involved in the manufacture, import, supply, and advertising of therapeutic goods, ensuring they meet quality, safety, and efficacy standards. These entities encompass companies, laboratories, hospitals, and individuals who engage in activities related to therapeutic goods. The geographic reach of the Act is national, applying to all therapeutic goods throughout the Commonwealth of Australia, including states and territories. However, the Act provides for certain exclusions and exemptions, such as goods used for personal use or research purposes, and it may also be subject to state and territory legislation where applicable. The Act's provisions can be extended or refined through subordinate instruments, which provide further details on specific requirements and procedures. This particular gazette from the Therapeutic Goods Administration under Section 38 of the Therapeutic Goods Act 1989, published by Dr Harry Rothenfluh, lists manufacturers granted licences to produce therapeutic goods. The licences granted include those to Nature's Care Manufacture Pty Limited, Capilano Honey Ltd, and Clinical Immunology PathWest Laboratory Medicine Fiona Stanley Hospital, each with their respective licence numbers and locations. This publication serves to notify the public of entities authorised to manufacture therapeutic goods, ensuring that consumers and stakeholders are aware of who is licensed to produce these essential products within Australia.

Key Provisions

The Therapeutic Goods Act 1989, through Section 38, mandates the Secretary to grant licences for the manufacture of therapeutic goods to certain entities. This particular piece of legislation, Gazette C2016G01247, notifies the public of the grant of such licences. Specifically, the licence has been granted to Nature's Care Manufacture Pty Limited, with the licence number MI-2015-LI-10093-1, for the address of OF 2 Minna Close, BELROSE, NSW, 2085. Another licence has been granted to Capilano Honey Ltd, identified by the licence number MI-2015-LI-11403-1, for their address at 399 Archerfield Road, Richlands, QLD, 4077. Additionally, a licence has been awarded to CLINICAL IMMUNOLOGY PATHWEST LABORATORY MEDICINE FIONA STANLEY HOSPITAL, with the licence number mi-2015-LI-09702-1, for their location at LEVEL 1 PATHOLOGY BUILDING FIONA STANLEY HOSPITAL, 9 ROBIN WARREN DRIVE, MURDOCH, WA, 6150. Under the Therapeutic Goods Act 1989, the grant of a manufacturing licence imposes certain obligations on the entities that receive it. These entities must adhere to stringent standards set forth by the Therapeutic Goods Administration (TGA) to ensure that the therapeutic goods they manufacture are safe, of high quality, and effective. Compliance with these standards is a fundamental requirement to maintain their licence. Failure to meet these obligations can result in the suspension or revocation of their licence, thereby impacting their ability to continue manufacturing and supplying therapeutic goods. The Therapeutic Goods Act 1989 also outlines various offences and penalties for breaches of the Act. For instance, if an entity operates without a valid manufacturing licence or fails to comply with the manufacturing standards, they may face legal consequences. The Act stipulates that such breaches could result in criminal charges, with penalties including substantial fines. The maximum penalty can vary depending on the severity of the breach but is designed to deter non-compliance and protect public health and safety. Additionally, civil actions may be taken to seek damages or injunctions against entities that violate the provisions of the Act. In summary, Section 38 of the Therapeutic Goods Act 1989 requires the Secretary to grant licences for the manufacture of therapeutic goods to specific entities. These licences come with significant obligations, including adherence to safety and quality standards. Failure to meet these obligations can result in severe legal consequences, including fines and the potential revocation of the licence. This legislative framework ensures that therapeutic goods available in the market are safe and of high quality, thereby protecting public health.