THERAPEUTIC GOODS AMENDMENT (2011 MEASURES NO. 1) BILL 2011

i Therapeutic Goods Amendment (2011 Measures No. 1) Bill 2011 No. , 2011

Contents

1 Short

title

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2 Commencement

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3 Schedule(s)

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Schedule 1--Amendments

Therapeutic Goods Act 1989

Therapeutic Goods Amendment (2011 Measures No. 1) Bill 2011 No. , 2011 1

A Bill for an Act to amend the Therapeutic Goods

Act 1989, and for related purposes

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repealed as set out in the applicable items in the Schedule

Amendments Schedule 1

Therapeutic Goods Amendment (2011 Measures No. 1) Bill 2011 No. , 2011 3

Schedule 1--Amendments

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:

(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)

Schedule 1 Amendments

4 Therapeutic Goods Amendment (2011 Measures No. 1) Bill 2011 No. , 2011

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

Amendments Schedule 1

Therapeutic Goods Amendment (2011 Measures No. 1) Bill 2011 No. , 2011 5

(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.

Commonwealth of Australia Bills

THERAPEUTIC GOODS AMENDMENT (2011 MEASURES NO. 1) BILL 2011