Publication of List of Manufacturers Granted Licence for the Manufacture of Therapeutic Goods under Section 38

Overview

The Therapeutic Goods Act 1989, enacted by the Commonwealth of Australia, serves as a foundational piece of legislation governing the regulation of therapeutic goods within the country. The Act was introduced to address the need for a comprehensive framework to ensure the safety, quality, and efficacy of therapeutic goods available to the public. It provides the legal basis for the regulation of medicines, medical devices, and other related products, ensuring they meet the necessary standards before being made available for use. The enacting body responsible for this legislation is the Parliament of Australia, with the policy objective of protecting public health by regulating therapeutic goods. This particular Gazette from 2017 pertains to the issuance of manufacturing licences, as per Section 38 of the Act, which grants the Secretary of the Department of Health the authority to issue such licences to entities that meet the specified criteria. The document lists licences granted to Nutribiotech Australia Pty Ltd and Toll Transport Pty Ltd, indicating compliance with the regulatory requirements set forth by the Therapeutic Goods Administration.

Scope and Application

The Therapeutic Goods Act 1989 applies to any entity or person engaged in the manufacture, supply, or importation of therapeutic goods within Australia. This encompasses a wide range of industries, including pharmaceutical, medical device, and complementary medicine sectors, and extends to any conduct or transactions involving the therapeutic goods regulated under this Act. The Act has a national jurisdictional reach, governing therapeutic goods across the Commonwealth, states, and territories of Australia. It provides a comprehensive framework for the regulation of therapeutic goods, ensuring their quality, safety, and efficacy. The Act includes provisions for issuing licences to manufacturers, which is exemplified in the notification of licences granted to Nutribiotech Australia Pty Ltd and Toll Transport Pty Ltd. While the Act broadly applies to therapeutic goods, there may be specific exclusions, exemptions, or thresholds detailed within the legislation or its subordinate instruments, which further define its application in particular contexts. These instruments can extend or restrict the application of the Act by detailing specific regulatory requirements or operational standards for different types of therapeutic goods or manufacturing processes.

Key Provisions

The Therapeutic Goods Act 1989, under Section 38, empowers the Secretary of the Department of Health, Therapeutic Goods Administration, to grant licences for the manufacture of therapeutic goods. In the current publication, Nutribiotech Australia Pty Ltd and Toll Transport Pty Ltd have been granted such licences, with the respective licence numbers MI-2016-LI-07393-1 and MI-2017-LI-04354-1. These licences allow the named entities to manufacture therapeutic goods, subject to the conditions and requirements specified in their respective licence agreements. Entities granted a manufacturing licence under the Therapeutic Goods Act 1989 are required to comply with stringent quality and safety standards. This includes maintaining Good Manufacturing Practice (GMP) standards, ensuring that all therapeutic goods produced meet the quality and efficacy standards outlined in the Act, and adhering to any specific conditions attached to their licence. Regular inspections and audits by the Therapeutic Goods Administration are conducted to ensure ongoing compliance. Entities must also maintain detailed records of their manufacturing processes and submit these records to the Administration upon request. Failure to comply with the provisions of the Therapeutic Goods Act 1989 and the conditions of a manufacturing licence can result in serious consequences. Offences under the Act can lead to both civil and criminal penalties. For example, knowingly manufacturing therapeutic goods that do not comply with the Act can result in substantial fines, with penalties potentially reaching up to $1,110,000 for corporations and $222,000 for individuals, as stipulated under Section 32HA of the Act. Additionally, individuals responsible for the breach may face imprisonment. The Act also provides for the cancellation or suspension of manufacturing licences for serious or repeated breaches, which can significantly impact the ability of the entity to continue manufacturing therapeutic goods.