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.
- 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 undertaking: Nutrition Warehouse Pty Limited (24 December 2014)