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Second Reading Speeches

Therapeutic Goods Amendment (2020 Measures No. 1) Bill 2020

Type
Government
Portfolio
Health
Originating house
House of Representatives
Status
Act
Parliament no
46

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Summary

Amends the:

Therapeutic Goods Act 1989
to: align certain device-related definitions with the equivalent definition in the European Union; enable the secretary to provide early scientific advice to a sponsor about the safety, quality or efficacy of a registrable medicine; enable a clinical trial sponsor to request variations to approved clinical trials; introduce a new preliminary assessment procedure for applications for new ingredients for listed and assessed listed medicines; remove a limitation on the circumstances in which medical practitioners may be authorised to supply specified unapproved therapeutic goods to their patients; remove certain offences for persons claiming to be able to arrange supply of therapeutic goods; impose a condition of registration or listing of therapeutic goods; specify the circumstances in which a sponsor may apply for the provisional registration of a medicine, without having to first obtain a provisional determination; introduce a data protection regime for assessed listed medicines; and make minor amendments and corrections; and
Patents Act 1990
to remove a reference to therapeutic devices.

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