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

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2004-2005-2006

 

The Parliament of the

Commonwealth of Australia

 

HOUSE OF REPRESENTATIVES

 

 

 

 

 

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

 

 

(1)     Schedule 1, item 1, page 3 (lines 4 and 5), omit the item.

[definition of restricted goods]

(2)     Schedule 1, item 3, page 3 (lines 8 and 9), omit the item.

[disallowance procedures]

(3)     Schedule 1, item 4, page 3 (lines 10 and 11), omit the item, substitute:

4  Section 23AA

Repeal the section, substitute:

23AA  Evaluation and registration of restricted goods

             (1)  Subject to this section, restricted goods may be evaluated and registered in accordance with the provisions of this Division as they apply to therapeutic goods.

             (2)  In spite of any provision of this Division, if the Secretary’s decision under paragraph 25(4AA)(d) is to register restricted goods, the Secretary must as soon as practicable notify the Minister of the decision to register the goods.

             (3)  The notice under subsection (2) is a legislative instrument.

             (4)  The registration of restricted goods must not take effect before the expiration of time within which a House of Parliament may disallow the instrument.

             (5)  If the instrument is disallowed or deemed to be disallowed under section 42 of the Legislative Instruments Act 2003 , the decision that the Secretary made ceases to have any effect.

[parliamentary approval of registration]

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

6      Subsection 25(4)

After “therapeutic devices”, insert “and are not restricted goods”.

7      After subsection 25(4)

Insert:

       (4AA)  If:

(a)     the therapeutic goods are not therapeutic devices and are restricted goods; and

(b)     the evaluation of the goods for registration has been completed;

                   the Secretary must:

(c)     notify the applicant in writing of his or her decision on the evaluation within 28 days of the making of the decision and, in the case of a decision not to register the goods, of the reasons for the decision; and

(d)     if the decision is to register the goods:

                              (i)  notify the applicant in writing that he or she has notified the Minister under section 23AA; and

                             (ii)  after the expiration of time within which a House of Parliament may disallow the instrument, and subject to disallowance of the instrument under section 23AA:

                                        (A)  notify the applicant in writing as soon as practicable that the goods will be included in the Register if the applicant gives the Secretary the certificate required under subsection 26B(1); and

                                        (B)  include the goods in the Register and give the applicant a certificate of registration if the applicant gives the Secretary the certificate required under subsection 26B(1).

                   To avoid doubt, subject to disallowance of the instrument under section 23AA, if the applicant gives the Secretary the certificate required under subsection 26B(1), the Secretary must include the goods in the Register under subparagraph (d)(ii) without inquiring into the correctness of the certificate.