Second Reading Speeches

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

Type
Government
Portfolio
Health and Aged Care
Originating house
House of Representatives
Status
Act
Parliament no
47

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Summary

Amends the

Therapeutic Goods Act 1989
to: require mandatory reporting of adverse events involving medical devices; provide a marketing approval pathway for biologicals that are for export only; remove merits review rights for a decision by the secretary to require a person to provide information or documents under the Act; enable the secretary to extend the period for a person to pay the amount stated in an infringement notice, and require a person to provide information or documents that are relevant to a contravention of the Act; extend the period for which seized goods can be held; provide that therapeutic goods advertising is excluded from advertising restrictions for certain health professionals or to persons purchasing goods on behalf of governments, registered charities or health facilities; enable the secretary to withdraw approval for the use of a restricted representation in an advertisement about therapeutic goods; enable the secretary to approve the importation or supply of substitute overseas prescription medicine that has been previously approved within Australia; provide that the secretary is not required to observe any requirements of the natural justice hearing rule when releasing therapeutic goods information; provide that sponsors of reportable medicines that are in shortage must provide updated information to the secretary; and make technical amendments.

We acknowledge the traditional owners and custodians of country throughout Australia and acknowledge their continuing connection to land, waters and community. We pay our respects to the people, the cultures and the elders past, present and emerging.

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