A person (including a company) who believes they have, or are likely to have breached an offence or civil penalty provision in the TGA legislation, can apply to the Secretary of the Department of Health and Ageing to enter into a written undertaking as an alternative to court action being commenced by the TGA.
If the Secretary accepts the Undertaking, the offending or potential offending party is bound by the terms agreed to in the Undertaking. A breach of the terms can result in the matter being referred to the Federal Court who can make orders under Section 42YL(5) of the Act.
Guidelines
- Enforceable undertaking guidelines
The acceptance of an enforceable undertaking is one of a number of options available to secure compliance with the Act and regulations
Enforceable undertakings
2024
2023
2022
- Enforceable undertaking: Doughbot Enterprises Pty Ltd and Stuart Singleton
- Enforceable undertaking: Strapit Medical and Sports Supplies Pty Ltd
2021
- Enforceable undertaking: Shen Neng Herbal Medicines Group Pty Ltd
- Enforceable undertaking: Chemforce Pty Ltd
2020
2014
2013
Topics