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Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005 [2006]

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4828

2004-2005-2006

 

The Parliament of the

Commonwealth of Australia

 

THE SENATE

 

 

 

 

Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005

 

 

(1)     Clause 1, page 1 (line 6), omit “ Repeal of Ministerial responsibility for approval of RU486 ”, substitute “ Ministerial responsibility ”.

[short title]

(2)     Schedule 1, items 1 to 5, page 3, TO BE OPPOSED .

[removal of ministerial discretion]

(3)     Schedule 1, page 3 (after line 13), at the end of the bill, add:

6  After subsection 6AA(2)

Insert:

(2A)  Before giving written approval in accordance with subsection (2), the Minister must:

                     (a)  seek written advice from the Australian Health Ethics Committee; and

                     (b)  consider that advice; and

                     (c)  prepare a written statement of reasons for the approval or refusal to approve the importation.

[advice from the TGA and the AHEC]

(4)     Schedule 1, page 3 (after line 13), at the end of the bill, add:

7  After subsection 6AA(2)

Insert:

          (2B)  The Minister must give written notice to a person seeking approval in accordance with this section of the approval of, or of the refusal to approve, the importation.

[Ministerial notification of response to all applications]

(5)     Schedule 1, page 3 (after line 13), at the end of the bill, add:

8  Subsection 6AA(4)

After “approval”, insert “together with the written advice received by the Minister from the Australian Health Ethics Committee and a written statement of reasons by the Minister for the approval of, or of the refusal to approve, the application”.

[Minister to confer with AHEC—reasons to be tabled]

(6)     Schedule 1, page 3 (after line 13), at the end of the bill, add:

9  At the end of section 6AA

             (6)  A written approval or refusal to approve in accordance with this section is a disallowable legislative instrument for the purposes of the Legislative Instruments Act 2003 .

[disallowance of ministerial approval]

(7)     Schedule 1, page 3 (after line 13), at the end of the bill, add:

10  Subsection 23AA(2)

Repeal the subsection, substitute:

             (2)  The Minister must give written notice together with a statement of reasons of the approval of, or of the refusal to approve the evaluation, registration or listing of restricted goods in accordance with this section.

             (3)  A written approval, or refusal to approve, the evaluation, registration or listing of restricted goods shall be laid before each House of the Parliament by the Minister within 5 sitting days of being given.

[ministerial notification re evaluation, registration or listing of restricted goods]

(8)     Title, page 1 (lines 1 and 2), omit “ repeal Ministerial responsibility for approval of RU486 ”, substitute “ conditions for the exercise of Ministerial responsibility in relation to certain therapeutic goods ”.

[title]