Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022

The majority voted in favour of a motion to agree with the bill's main idea. In other words, they voted to read it for a second time. They can now discuss it in greater detail.

What is the bill's main idea?

According to the bills digest:

The Bill proposes amendments to the Therapeutic Goods Act 1989 (the Act) that include:

• imposing a new reporting requirement on CEOs of healthcare facilities for adverse events involving medical devices
• establishing a new ‘export only’ pathway for biologicals
• expanding the Therapeutic Goods Administration’s information gathering powers
• enabling the withdrawal of restricted advertising approval for therapeutic goods if concerns arise following the release of new efficacy information
• expanding the list of exempt persons who may receive direct therapeutic goods advertising and for whom the Act’s advertising requirements do not apply
• expanding existing powers to enable the importation or supply of (unapproved) substitutable medicines in the event of a medicine shortage where no appropriate alternative is available in the Australian Register of Therapeutic Goods and it is in the interests of public health.

Several of these amendments build on ongoing therapeutic goods reforms and are in response to stakeholder feedback.