Therapeutic Products Bill - Amendment paper No 381
Therapeutic Products Bill - Amendment paper No 381
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Therapeutic Products Bill - Amendment paper No 381
No 381
House of Representatives
Supplementary Order Paper
Tuesday, 18 July 2023
Therapeutic Products Bill
Proposed amendment
Brooke van Velden, in Committee, to move the following amendment:
Clause 379
After clause 379(2) (page 208, after line 12), insert:
(2A)
An exemption may be granted in reliance, in whole or in part, on the report, assessments, or decision made by, or information received from, an entity designated under section 346.
Explanatory note
This Supplementary Order Paper amends the Therapeutic Products Bill by inserting new subclause (2A), which intends to allow the Regulator to rely on evidence from a designated entity when granting an exemption to a therapeutic product or thing, or class or product or things, from the application of any provision of the Act. The proposed change makes it explicit that trusted overseas evidence may be considered by the Regulator with respect to granting an exemption, and therefore mitigates the risks of delay and uncertainty that may arise about this if it is not clearly allowed for in the legislation.
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Therapeutic Products Bill - Amendment paper No 381
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