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

Overview

The Therapeutic Goods Act 1989 was enacted by the Parliament of Australia to regulate the supply and quality of therapeutic goods, including medicines, medical devices, and blood and blood components, to ensure they are safe, of high quality, and effective. This Act was introduced to address the need for a robust regulatory framework that safeguards public health by controlling the approval, manufacturing, advertising, and distribution of therapeutic goods. The objective of the Act is to maintain and improve the health of Australians through the regulation of therapeutic goods, ensuring they meet required standards. This notification from the Department of Health, Therapeutic Goods Administration, under Section 38 of the Therapeutic Goods Act 1989, informs the public of the grant of a Licence to Manufacture Therapeutic Goods to specified entities. This administrative process ensures that only authorised manufacturers can legally produce therapeutic goods, thereby upholding the standards set by the Act. By publishing the list of manufacturers granted such licences, the Therapeutic Goods Administration maintains transparency and accountability in the therapeutic goods market.

Scope and Application

The Therapeutic Goods Act 1989 applies to the regulation and administration of therapeutic goods within Australia, ensuring that these goods meet safety, quality, and efficacy standards. The Act governs a wide range of therapeutic goods including medicines, medical devices, blood and tissues, and therapeutic goods advertised for therapeutic purposes. It applies to entities and individuals who manufacture, supply, or import therapeutic goods, as well as to the conduct and transactions involved in the provision of these goods to the public. The Act’s jurisdiction covers the Commonwealth, extending its reach across states and territories to maintain a consistent regulatory framework for therapeutic goods throughout Australia. The Act may have certain exclusions or exemptions, particularly for specific types of goods or for goods used for research and development purposes, but these are clearly defined within the Act or its subordinate instruments. Subordinate instruments may further refine or extend the application of the Act, ensuring that it remains responsive to emerging issues and technological advancements in the therapeutic goods sector.

Key Provisions

The Therapeutic Goods Act 1989, under Section 38, facilitates the granting of licences to entities for the manufacture of therapeutic goods, with Section 38(1) stipulating the process for such grants. In this instance, the Secretary has granted licences to two companies: Rainbow and Nature Pty Ltd (Licence No. MI-2016-LI-07028-1) and Complementary Medicines Group Pty Ltd (Licence No. MI-2016-LI-07542-1). These licences permit the respective companies to manufacture therapeutic goods in compliance with the legislative requirements set out in the Act. The obligations imposed on the licensees under the Therapeutic Goods Act 1989 include adherence to stringent quality and safety standards as outlined in the Act. Both Rainbow and Nature Pty Ltd and Complementary Medicines Group Pty Ltd must ensure that their manufacturing processes comply with Good Manufacturing Practice (GMP) standards and that the therapeutic goods produced are safe, of high quality, and effective. This includes maintaining detailed records of all manufacturing activities and being subject to regular inspections by the Therapeutic Goods Administration (TGA) to verify compliance with these standards. Failure to comply with the requirements of the Therapeutic Goods Act 1989 can result in significant penalties. Under Section 42HA, the Act outlines various offences that can be committed, such as manufacturing therapeutic goods that do not meet the required standards or failing to maintain proper records. The penalties for these offences can include substantial fines, imprisonment, or both, depending on the severity of the breach. For example, an individual or corporation found guilty of manufacturing therapeutic goods that are not of acceptable quality may face fines of up to $1,650,000 or imprisonment for up to 10 years, or both, as stipulated in Section 42HA(3) of the Act.