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TGA publishes updated Enforceable Undertaking guidelines

On September 30, 2019, the TGA published revised guidelines for making an offer of enforceable undertaking to the TGA. An enforceable undertaking is a court-enforceable commitment by an individual or a company to carry out certain activities.

Under section 42YL of the Therapeutic Goods Act 1989 (the Act), the Secretary of the Department of Health can accept an offer of an enforceable undertaking. An enforceable undertaking is relatively quick compliance solution. It may include encouraging entities (individuals or companies) to improve their compliance arrangements or restrict the activities they can undertake. This can help entities meet their obligations under the Act and other regulations into the future, which in turn helps protect consumers and public health.

The TGA regards the enforceable undertaking as an important compliance tool in situations where there is evidence of a breach of the Act or regulations, but where it may not be in the public interest to take civil or criminal compliance action. Generally, enforceable undertakings are not used in cases involving deliberate misconduct, fraud, or conduct involving a high level of recklessness.

For an individual or company in potential breach of the Act or regulations, entering into an enforceable undertaking can be a cost-effective alternative to criminal or civil compliance action.

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