Publication of List of Manufacturers Revoked from Licensing for the Manufacture of Therapeutic Goods – 9 April 2025

Overview

The Therapeutic Goods Act 1989 was enacted to provide a regulatory framework for the approval, manufacture, advertising, and quality control of therapeutic goods in Australia. This Act addresses the need for ensuring that therapeutic goods available in Australia are safe, of high quality, and effective for their intended use. The enactment of this Act was driven by the need to protect public health by ensuring that only therapeutic goods that meet certain standards are available on the market. The Therapeutic Goods Administration, as the administrative arm of the Department of Health and Aged Care, is the body responsible for enforcing this Act. The policy objective of the Act is to safeguard the health and safety of Australians by regulating the supply and advertising of therapeutic goods. The revocation of a licence to manufacture therapeutic goods, as demonstrated in the gazetted notice of 9 April 2025, is a measure taken to maintain these standards by ensuring that only entities complying with the regulatory requirements are permitted to manufacture such goods.

Scope and Application

The Therapeutic Goods Act 1989 applies to entities and individuals involved in the manufacture, supply, importation, and advertising of therapeutic goods in Australia. This includes pharmaceutical products, medical devices, blood, and tissues, ensuring they meet specific safety, quality, and efficacy standards. The Act regulates the entire supply chain of therapeutic goods and extends its jurisdiction across the Commonwealth, thereby encompassing all states and territories of Australia. The Act provides for the issuance, suspension, and revocation of licences for therapeutic goods manufacturers, as demonstrated by the revocation of licences for specified entities, including Global Medical Solutions Australia Pty Limited, Herbal-ID, Biotest Laboratories Pty Ltd, and Access Industries for the Disabled Ltd, all of which requested the revocation of their respective licences. The Act may also include provisions for exclusions or exemptions, but these are not detailed in the given excerpt. The scope of the Act can be further extended or refined through subordinate instruments, which may detail specific regulations or guidelines for certain types of therapeutic goods or manufacturing processes.

Key Provisions

The Therapeutic Goods Act 1989 (the Act) outlines several key provisions related to the regulation of therapeutic goods within Australia. Section 41(1)(e) specifically allows the Secretary of the Department of Health and Aged Care, Therapeutic Goods Administration, to revoke a Licence to Manufacture Therapeutic Goods upon request from the manufacturer. This revocation process was exercised in the recent gazette, C2025G00205, where the licences for four manufacturers were revoked: GLOBAL MEDICAL SOLUTIONS AUSTRALIA PTY LIMITED, HERBAL-ID, BIOTEST LABORATORIES PTY LTD, and ACCESS INDUSTRIES FOR THE DISABLED LTD. The revocations were made in accordance with the manufacturers' requests, ensuring that they were no longer authorised to produce therapeutic goods within Australia. Under the Act, the obligations imposed on entities holding a Licence to Manufacture Therapeutic Goods include adherence to stringent quality and safety standards. Manufacturers must ensure that their products meet the requirements set out in the Therapeutic Goods Regulations 1991, which include specifications for product quality, labelling, and safety. Additionally, manufacturers are required to maintain records of their manufacturing processes and to report any adverse events associated with their products. Failure to comply with these obligations can lead to the suspension or revocation of their licence, as evidenced by the recent revocations. In terms of consequences for breaches of the Act, Section 41(3) states that any person who manufactures a therapeutic good in contravention of the Act, or without the required licence, is guilty of an offence. This offence is a strict liability offence, meaning that it can be prosecuted even if there was no intent to contravene the Act. The maximum penalty for this offence is significant, with fines potentially reaching up to $1.1 million for individuals and up to $5.5 million for bodies corporate, as stipulated in Section 42(1) of the Act. These penalties reflect the seriousness of manufacturing therapeutic goods without the appropriate authorisation and the potential risks such activities pose to public health and safety.