Publication of List of Manufacturers Granted Licence for the Manufacture of Therapeutic Goods – 6 August 2021

Overview

The Therapeutic Goods Act 1989 was enacted to provide a legislative framework for regulating therapeutic goods in Australia, aiming to ensure that these products are safe, of acceptable quality, and properly represented. The Act was introduced to address the need for comprehensive regulation of therapeutic goods to protect public health and safety. This includes overseeing the manufacturing, importation, advertising, and sale of therapeutic goods. The Therapeutic Goods Administration, under the Department of Health, is the enacting body responsible for the administration and enforcement of this legislation. The policy objective of the Act is to ensure that therapeutic goods available in Australia meet necessary standards and that any risks associated with their use are minimised. This gazette, dated 6 August 2021, specifically details the grant of manufacturing licences under section 38 of the Therapeutic Goods Act 1989. The licences were granted to Biomebank and Mainfreight Distribution Pty Ltd, confirming their authorisation to manufacture therapeutic goods. This action by the Delegate of the Secretary of the Department of Health, Katherine Clark, underscores the ongoing commitment to maintaining stringent oversight and quality assurance in the production of therapeutic goods within Australia.

Scope and Application

The Therapeutic Goods Act 1989 governs the regulation of therapeutic goods in Australia, including the licensing of entities that manufacture these goods. The Act applies to any person or entity involved in the manufacture of therapeutic goods within Australia, ensuring that such activities comply with the stringent standards set to protect public health. The Act’s scope encompasses various industries, including pharmaceuticals, medical devices, and biological products, mandating that entities granted a manufacturing licence adhere to good manufacturing practices. Geographically, the Act applies across the Commonwealth of Australia, extending its regulatory reach uniformly throughout the nation. The Act allows for the exclusion of certain goods and manufacturing processes under specific conditions, and the application for licences and compliance can be further detailed through subordinate instruments. The published list of licence holders, such as Biomebank and Mainfreight Distribution Pty Ltd, reflects the Act's enforcement and oversight role in ensuring that only authorised entities manufacture therapeutic goods within the country.

Key Provisions

The Therapeutic Goods Act 1989 (the "Act") includes a provision that mandates the publication of a list of manufacturers who have been granted a licence to manufacture therapeutic goods. This requirement is detailed in section 38 of the Act, which stipulates that the Secretary of the Department of Health, Therapeutic Goods Administration, must issue a written notice concerning the grant of such licences. In the most recent publication dated 6 August 2021, the Delegate of the Secretary, Katherine Clark, has listed two entities that have been granted licences to manufacture therapeutic goods. Specifically, the first entity, Biomebank, was granted Licence No. MI-2019-LI-09784-1 and is located at East Wing Level 1, 2 Ann Nelson Drive, Thebarton, SA, 5031. The second entity, Mainfreight Distribution Pty Ltd, was granted Licence No. MI-2020-LI-00260-1 and is situated at 55 Yarrunga Street, Prestons, NSW, 2170. The Act imposes several obligations and requirements on the parties granted a licence to manufacture therapeutic goods. These obligations are aimed at ensuring that the therapeutic goods produced meet the necessary standards of quality, safety, and efficacy. The licence holders must adhere to Good Manufacturing Practice (GMP) standards, which encompass various aspects of the manufacturing process, including the design and construction of manufacturing facilities, the control of manufacturing processes, the qualification and training of personnel, and the maintenance of records. Additionally, the licence holders must ensure that their products comply with the standards set out in the Therapeutic Goods Regulations 1990 and any other applicable regulations. Failure to comply with these obligations could result in the suspension or revocation of the licence. In the event that a licence holder breaches the provisions of the Act or the regulations, there are potential offences, penalties, and consequences that may be imposed. Breaches of the Act or regulations may result in criminal charges being laid against the individual or corporate entities responsible for the breach. The maximum penalties for offences under the Act vary depending on the nature and severity of the breach. For example, section 35ZD of the Act provides that an individual who commits a serious or repeated breach of the Act may be liable to a fine of up to $222,000, while a body corporate may be liable to a fine of up to $1,110,000. In addition to criminal penalties, the Therapeutic Goods Administration may also take regulatory action against a licence holder who breaches the Act or regulations. This action may include the suspension or revocation of the licence, the imposition of conditions on the licence, or the issuance of a public warning about the breach. The potential civil and criminal consequences for breach of the Act or regulations serve as a deterrent to non-compliance and underscore the importance of adhering to the obligations imposed by the Act.