THERAPEUTIC GOODS AMENDMENT BILL (NO. 2) 2005

i Therapeutic Goods Amendment Bill (No. 2) 2005 No. , 2005

Contents

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

Commencement .............................................................................1

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

Schedule 1--Amendment of the Therapeutic Goods Act 1989

Therapeutic Goods Amendment Bill (No. 2) 2005 No. , 2005 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 Act

(No. 2) 2005.

2 Commencement

(1) Each provision of this Act specified in column 1 of the table

commences, or is taken to have commenced, in accordance with

column 2 of the table. Any other statement in column 2 has effect

according to its terms.

2 Therapeutic Goods Amendment Bill (No. 2) 2005 No. , 2005

Commencement information

Column 1

Column 2

Column 3

Provision(s)

Commencement

Date/Details

1. Sections 1 to 3

and anything in

this Act not

elsewhere covered

by this table

The day on which this Act receives the

Royal Assent.

2. Schedule 1

A single day to be fixed by Proclamation.

However, if any of the provision(s) do not

commence within the period of 6 months

beginning on the day on which this Act

receives the Royal Assent, they commence

on the first day after the end of that period.

Note:

This table relates only to the provisions of this Act as originally

passed by the Parliament and assented to. It will not be expanded to

deal with provisions inserted in this Act after assent.

(2) Column 3 of the table contains additional information that is not

part of this Act. Information in this column may be added to or

edited in any published version of this Act.

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repealed as set out in the applicable items in the Schedule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.

Amendment of the Therapeutic Goods Act 1989 Schedule 1

Therapeutic Goods Amendment Bill (No. 2) 2005 No. , 2005 3

Schedule 1--Amendment of the Therapeutic

Goods Act 1989

1 Paragraph 25(4)(d)

Repeal the paragraph, substitute:

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

(i) notify the applicant in writing that the goods will be

included in the Register if the applicant gives the

Secretary either the certificate required under subsection

26B(1) or a notice (in accordance with a form approved,

in writing, by the Secretary) that a certificate under that

subsection is not required in relation to the application;

and

(ii) include the goods in the Register and give the applicant

a certificate of registration if the applicant gives the

Secretary either the certificate required under subsection

26B(1) or a notice (in accordance with a form approved,

in writing, by the Secretary) that a certificate under that

subsection is not required in relation to the application.

2 Subsection 25(4) (second sentence)

Repeal the sentence, substitute:

To avoid doubt, if the applicant gives the Secretary the certificate

required under subsection 26B(1) or a notice that a certificate

under that subsection is not required in relation to the application,

the Secretary must include the goods in the Register under

subparagraph (d)(ii) without inquiring into the correctness of the

certificate or the notice.

3 At the end of subsection 25(4A)

Add "or a notice given under subparagraph (4)(d)(ii)".

4 Paragraph 26(1)(aa)

Repeal the paragraph, substitute:

(aa) if goods are not therapeutic devices--the application is

accompanied by either:

(i) the certificate required under subsection 26B(1); or

Schedule 1 Amendment of the Therapeutic Goods Act 1989

4 Therapeutic Goods Amendment Bill (No. 2) 2005 No. , 2005

(ii) a notice (in accordance with a form approved, in

writing, by the Secretary) that a certificate under that

subsection is not required in relation to the application;

and

5 Paragraph 26(1A)(b)

Repeal the paragraph, substitute:

(b) the application is accompanied by either:

(i) the certificate required under subsection 26B(1); or

(ii) a notice that a certificate under that subsection is not

required in relation to the application; and

6 At the end of subsection 26(1A)

Add "or the notice".

7 At the end of subsection 26(1B)

Add "or a notice given under subparagraph (1)(aa)(ii)".

8 Paragraph 26A(1)(b)

Repeal the paragraph, substitute:

(b) the application is accompanied by either:

(i) the certificate required under subsection 26B(1); or

(ii) a notice (in accordance with a form approved, in

writing, by the Secretary) that a certificate under that

subsection is not required in relation to the application;

and

9 Paragraph 26A(1A)(b)

Repeal the paragraph, substitute:

(b) the application is accompanied by either:

(i) the certificate required under subsection 26B(1); or

(ii) a notice that a certificate under that subsection is not

required in relation to the application; and

10 At the end of subsection 26A(1A)

Add "or the notice".

11 At the end of subsection 26A(1B)

Amendment of the Therapeutic Goods Act 1989 Schedule 1

Therapeutic Goods Amendment Bill (No. 2) 2005 No. , 2005 5

Add "or a notice given under subparagraph (1)(b)(ii)".

12 Before subsection 26B(1)

Insert:

(1A) A certificate is required under subsection (1) in relation to an

application for registration or listing of therapeutic goods only if:

(a) the applicant is required to submit evidence or information to

establish the safety or efficacy of the goods as part of the

process of applying for registration or listing; and

(b) in order to satisfy that requirement, the applicant relies (in

whole or in part) on evidence or information that another

person submitted to the Secretary:

(i) to establish the safety or efficacy of other therapeutic

goods that have already been registered or listed; and

(ii) as part of the process of applying for the registration or

listing of those other goods.

13 Subsection 26B(1)

Omit "certificate required by", substitute "certificate required under".

14 After section 26B

Insert:

26BA Approved form for notices

An approval of a form for a notice for the purposes of subsection

25(4), 26(1) or 26A(1) may require or permit the notice to be given

in accordance with specified software requirements:

(a) on a specified kind of data processing device; or

(b) by way of a specified kind of electronic transmission.

15 Application

The amendments made by this Schedule apply to applications for

registration or listing of therapeutic goods that are made on or after the

day on which this Schedule commences.

Commonwealth of Australia Bills

THERAPEUTIC GOODS AMENDMENT BILL (NO. 2) 2005