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Therapeutic Goods Amendment (2011 Measures No. 1) Act 2011

Authoritative Version
  • - C2011A00077
  • In force - Latest Version
Act No. 77 of 2011 as made
An Act to amend the Therapeutic Goods Act 1989, and for related purposes
Administered by: Health and Aged Care
Originating Bill: Therapeutic Goods Amendment (2011 Measures No. 1) Bill 2011
Registered 28 Jul 2011
Date of Assent 25 Jul 2011
Table of contents.

 

 

 

 

 

 

Therapeutic Goods Amendment (2011 Measures No. 1) Act 2011

 

No. 77, 2011

 

 

 

 

 

An Act to amend the Therapeutic Goods Act 1989, and for related purposes

  

  


Contents

1............ Short title............................................................................................. 1

2............ Commencement................................................................................... 2

3............ Schedule(s)......................................................................................... 2

Schedule 1—Amendments                                                                                                3

Therapeutic Goods Act 1989                                                                                     3

 


 

 

Therapeutic Goods Amendment (2011 Measures No. 1) Act 2011

No. 77, 2011

 

 

 

An Act to amend the Therapeutic Goods Act 1989, and for related purposes

[Assented to 25 July 2011]

The Parliament of Australia enacts:

1  Short title

                   This Act may be cited as the Therapeutic Goods Amendment (2011 Measures No. 1) Act 2011.

2  Commencement

                   This Act commences on the day after this Act receives the Royal Assent.

3  Schedule(s)

                   Each Act that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms.


 

Schedule 1Amendments

  

Therapeutic Goods Act 1989

1  Subsections 9D(6) to (8)

Repeal the subsections, substitute:

Form and manner of requests

             (6)  The Secretary may, by writing:

                     (a)  approve a form for particular kinds of requests under this section; and

                     (b)  approve the manner of making particular kinds of requests under this section.

             (7)  If:

                     (a)  the Secretary has approved a form for, and the manner of making, a kind of request under this section; and

                     (b)  either:

                              (i)  the kind of request is one under subsection (3) and which, under the regulations, must be decided within 175 or 255 working days; or

                             (ii)  the kind of request is one prescribed by the regulations for the purposes of this subparagraph;

then a request of that kind is not effective unless:

                     (c)  the request is in accordance with that form; and

                     (d)  the request contains the information required by that form; and

                     (e)  the request is made in that manner; and

                      (f)  any prescribed application fee has been paid.

2  Subsection 24(2)

Omit “Subject to section 24D, an”, substitute “An”.

3  Section 24A

Omit “sections 24B and 24D”, substitute “section 24B”.

4  Subsections 24D(2) to (6)

Repeal the subsections, substitute:

             (2)  If:

                     (a)  the applicant has paid the whole of the evaluation fee; and

                     (b)  the evaluation is completed, but not within the period referred to in subsection (1);

then 25% of the evaluation fee must be refunded to the applicant.

             (3)  For the purposes of subsection (2), the evaluation is taken to be completed when the applicant is notified under subsection 25(4) of the Secretary’s decision on the evaluation.

Note:       The heading to section 24D is altered by omitting “Reduction” and substituting “Refund”.

5  Paragraphs 31(1B)(b) and (1C)(b)

Omit “pre‑submission form”, substitute “pre‑submission planning form”.

6  Application

(1)       The amendment made by item 1 applies in relation to requests made on or after the commencement of that item.

(2)       The amendments made by items 2 to 4 apply in relation to applications made under section 23 of the Therapeutic Goods Act 1989 on or after the commencement of those items.

(3)       The amendment made by item 5 applies in relation to notices given on or after the commencement of that item.

7  Transitional—approved forms

An approval in force under subsection 9D(6) of the Therapeutic Goods Act 1989 immediately before the commencement of this item continues in force on and after that commencement as if it were an approval in force under paragraph 9D(6)(a) of that Act.

8  Transitional—registration or listing conditions

(1)       If:

                     (a)  on or after the day on which this item commences, the first instrument made under subsection 28(2) of the principal Act takes effect; and

                     (b)  immediately before that first instrument takes effect, a condition on the registration or listing of therapeutic goods was in force under subsection 28(2B) of the principal Act; and

                     (c)  either:

                              (i)  if that condition was in force because of subitem 57(3) of Schedule 7 to the amending Act—that condition was imposed in writing under subsection 28(1) of the principal Act (as in force at any time before 25 January 2010) and was described as a standard condition; or

                             (ii)  in any other case—that condition was imposed by notice in writing under subsection 28(2B) of the principal Act and was described as a standard condition;

then that condition ceases to be in force at the time that first instrument takes effect.

Note 1:    If, immediately before that first instrument takes effect, multiple conditions on the registration or listing of therapeutic goods were in force under subsection 28(2B) of the principal Act, this item has a separate application in relation to each of those conditions.

Note 2:    Section 12 of the Legislative Instruments Act 2003 deals with when a legislative instrument takes effect.

(2)       Subitem 57(1) of Schedule 7 to the amending Act is subject to an instrument under subsection 28(2) of the principal Act providing that specified conditions apply only to a specified class of therapeutic goods that are registered or listed on or after that instrument takes effect.

(3)       In this item:

amending Act means the Therapeutic Goods Amendment (2009 Measures No. 1) Act 2009.

principal Act means the Therapeutic Goods Act 1989.


 

 

[Minister’s second reading speech made in—

House of Representatives on 23 March 2011

Senate on 14 June 2011]

(41/11)