Publication of List of Manufacturers Granted Licence for the Manufacture of Therapeutic Goods

Overview

The Therapeutic Goods (Manufacturing Licences – Prescribed Information) Determination 2020 was enacted to provide further detail concerning the grant of a Licence to Manufacture Therapeutic Goods under section 38 of the Therapeutic Goods Act 1989. This Act was introduced to address the need for regulation and oversight in the manufacturing of therapeutic goods in Australia, ensuring that these goods are safe, of high quality, and meet the necessary standards. The determination was made by Katherine Clark, a delegate of the Secretary of the Department of Health, Therapeutic Goods Administration, who is responsible for administering the Act. The policy objective of the Therapeutic Goods Act 1989 is to protect public health by regulating therapeutic goods, including their manufacture, and ensuring they are safe and of acceptable quality. This determination provides the specific details of the licences granted to various entities for the manufacture of therapeutic goods, outlining the authorised activities and conditions under which these licences operate.

Scope and Application

The Therapeutic Goods Act 1989, through which the Secretary has granted licences to specific entities for the manufacture of therapeutic goods, applies to entities involved in the production of such goods within Australia. The Act covers various industries, including but not limited to, pharmaceuticals, medical devices, and biologicals, ensuring that these products meet the required safety, quality, and efficacy standards. The licence granted to Finishing Services Pty Ltd, Delta Laboratories Pty Ltd, GMP Pharmaceuticals Pty Limited, and JMAC (WA) Pty Ltd, trading as Pharmaust Manufacturing, signifies their authorisation to manufacture therapeutic goods under the regulatory framework established by the Act. The geographic reach of this Act is nationwide, as it applies to all therapeutic goods manufactured in Australia, irrespective of the location of the manufacturing entities. While the Act generally applies to all therapeutic goods manufacturers, there may be exclusions or exemptions specified within subordinate instruments, which are often detailed in regulations or guidelines issued under the authority of the Act. These subordinate instruments may further define the scope of application, including specific conditions or standards that licensed entities must adhere to in their manufacturing processes.

Key Provisions

The Gazette published under section 38 of the Therapeutic Goods Act 1989 outlines the grant of a Licence to Manufacture Therapeutic Goods to several entities. Specifically, Finishing Services Pty Ltd, with licence number MI-2019-LI-06778-1, Delta Laboratories Pty Ltd, with licence number MI-2017-LI-11602-1, GMP Pharmaceuticals Pty Limited, with licence number MI-2019-LI-01002-1, and JMAC (WA) Pty Ltd trading as Pharmaust Manufacturing, with licence number MI-2019-LI-02258-1, have all been granted manufacturing licences. These licences allow the entities to legally manufacture therapeutic goods within Australia. The granting of these manufacturing licences imposes certain obligations and requirements on the licensed entities. Each entity must comply with all relevant standards and regulations set forth in the Therapeutic Goods Act 1989 and any associated regulations or guidelines. This includes maintaining quality control processes, ensuring the safety and efficacy of the therapeutic goods, and adhering to Good Manufacturing Practice (GMP) standards. Additionally, these entities must ensure that their manufacturing processes meet the necessary hygiene, safety, and environmental standards. Regular inspections and audits may be conducted by the Therapeutic Goods Administration (TGA) to ensure compliance with these obligations. Failure to comply with the obligations and requirements set forth in the Therapeutic Goods Act 1989 and the terms of the manufacturing licence can lead to various penalties and consequences. Civil and criminal offences may be charged for non-compliance, which can result in significant financial penalties. For example, under section 30 of the Therapeutic Goods Act 1989, an entity may be fined up to $66,600 for a serious or repeated breach of the Act. Additionally, the TGA has the authority to suspend or revoke a manufacturing licence if it is found that an entity is not meeting the required standards or is engaging in illegal activities. Such actions can have serious implications for the entity’s ability to continue manufacturing therapeutic goods in Australia.