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 Parliament, was introduced to address the need for stringent regulation of therapeutic goods, including medicines, medical devices, and blood products, to ensure their quality, safety, and efficacy. The Act provides the legal framework for the regulation of therapeutic goods throughout Australia, allowing the Therapeutic Goods Administration (TGA) to monitor and control these products from manufacturing through to sale. The gazette C2019G00638, issued on 12 July 2019 by Katherine Clark, Delegate of the Secretary of the Department of Health, Therapeutic Goods Administration, serves to publicise the granting of manufacturing licences to specific entities. This public notification aligns with the policy objective of maintaining transparency and accountability in the therapeutic goods market, ensuring that only authorised manufacturers can produce such goods within Australia.

Scope and Application

The Therapeutic Goods Act 1989, administered by the Therapeutic Goods Administration (TGA) under the Department of Health, governs the regulation of therapeutic goods in Australia. This Act applies to any person or entity involved in the manufacture, importation, supply, or advertising of therapeutic goods, including medicines, medical devices, and other health-related products. The legislation's jurisdictional reach is national, ensuring uniform standards and oversight across all states and territories of Australia. The Act applies to the specified manufacturers by requiring them to obtain a Licence to Manufacture Therapeutic Goods, as evidenced by the publication of the list of manufacturers who have been granted such licences. This ensures that only authorised entities can manufacture therapeutic goods, thereby safeguarding public health by maintaining quality and safety standards. The Act also provides for exclusions and exemptions where appropriate, and may extend its application through subordinate instruments to cover additional activities or products as necessary.

Key Provisions

The Therapeutic Goods Act 1989 (the Act) provides the legal framework for regulating therapeutic goods in Australia. Section 38 of the Act (subsections 38(1) to 38(3)) sets out the requirements for granting a Licence to Manufacture Therapeutic Goods. The Delegate of the Secretary of the Department of Health, Therapeutic Goods Administration, in this case Katherine Clark, has exercised the power granted under this section to publish the details of the licence granted to several entities. These entities are ABC Can Pty Ltd, Probiotics Australia Pty Ltd, Australia Nuclear Science and Technology Organisation trading as ANSTO, and MULTIPACK PTY LTD. Each entity is granted a specific licence number and the address of their manufacturing site is also provided. Under the Act, the granting of a licence to manufacture therapeutic goods imposes several obligations on the licence holder. The licence holders must adhere to the quality and safety standards set out by the Therapeutic Goods Administration (TGA). They must ensure that the therapeutic goods they manufacture comply with the relevant standards and regulations. The licence holders must also maintain records of their manufacturing processes and be able to provide these records to the TGA upon request. Failure to comply with these obligations may result in the suspension or revocation of their licence. The Act also outlines various offences and penalties for breach of the requirements. Section 38(4) of the Act provides that any person who contravenes a condition of their licence may be liable for a penalty. The penalty for an individual is a fine of up to $22,200 or imprisonment for up to two years, or both. For a body corporate, the penalty is up to $111,000. In addition to these penalties, the TGA may also take other regulatory action against a licence holder who breaches the conditions of their licence. This may include the suspension or revocation of their licence, or legal proceedings to enforce compliance.