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Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017

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8353

2016-2017-2018

 

The Parliament of the

Commonwealth of Australia

 

THE SENATE

 

 

 

 

 

Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017

 

(1)           Clause 2, page 2 (table item 6), omit the table item, substitute:

6.  Schedule 6, Part 2

The day 6 months after the day on which the report of the review provided for in item 51A of Schedule 6 is tabled in the Senate.

 

[commencement—removal of pre-approval process]

(2)           Schedule 2, item 15, page 19 (after line 24), after subsection 26BF(5), insert:

             (6)  All indications citing traditional evidence must include the following statement: This traditional indication is not in accordance with modern medical knowledge and there is no scientific evidence that this product is effective.

[requirement for disclaimer]

(3)           Schedule 6, item 38, page 97 (line 12), omit “may”, substitute “must”.

[directions about advertisements]

(4)           Schedule 6, item 38, page 100 (line 5), omit “may”, substitute “must”.

[public warning notices]

(5)           Schedule 6, item 38, page 100 (line 21), omit “may”, substitute “must”.

[public warning notices]

(6)           Schedule 6, page 105 (after line 5), after item 51, insert:

51A  Independent review

(1)       The Minister must cause an independent review to be conducted into the operation of the amendments made by this Part, including, but not limited to, the effectiveness of the Therapeutic Goods Administration in the handling of complaints about therapeutic goods advertisements directed to the public.

(2)       The review must be conducted as soon as practicable after the end of 3 years after this item commences.

(3)       The persons who conduct the review must give the Minister a writt en report of the review.

(4)       The Minister must cause a copy of the report to be tabled in each House of the Parliament within 15 sitting days of that House after the report is given to the Minister.

[independent review]