Federal Register of Legislation - Australian Government

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Therapeutic Goods Amendment Act 2000

  • - C2004A00604
  • In force - Latest Version
Act No. 12 of 2000 as made
An Act to amend the Therapeutic Goods Act 1989 to give effect to Australia's obligations regarding therapeutic goods under an agreement on mutual recognition with the European Free Trade Association, and for related purposes
Administered by: Health and Aged Care
Originating Bill: Therapeutic Goods Amendment Bill 1999
Date of Assent 31 Mar 2000
Table of contents.

 

 

 

 

Therapeutic Goods Amendment Act 2000

 

No. 12, 2000


 

 

 

 

Therapeutic Goods Amendment Act 2000

 

No. 12, 2000

 

 

 

 

An Act to amend the Therapeutic Goods Act 1989 to give effect to Australia’s obligations regarding therapeutic goods under an agreement on mutual recognition with the European Free Trade Association, and for related purposes

  

  


Contents

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

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

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

Schedule 1—Amendment of the Therapeutic Goods Act 1989                     3

 


Therapeutic Goods Amendment Act 2000

No. 12, 2000

 

 

 

An Act to amend the Therapeutic Goods Act 1989 to give effect to Australia’s obligations regarding therapeutic goods under an agreement on mutual recognition with the European Free Trade Association, and for related purposes

[Assented to 31 March 2000]

The Parliament of Australia enacts:

1  Short title

                   This Act may be cited as the Therapeutic Goods Amendment Act 2000.

2  Commencement

                   This Act commences on the day on which it 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                   Each Act that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms.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 1Amendment of the Therapeutic Goods Act 1989

  

1  Subsection 3(1) (definition of conformity assessment body)

Omit “Mutual Recognition Agreement”, substitute “EC Mutual Recognition Agreement or the EFTA Mutual Recognition Agreement”.

2  Subsection 3(1) (definition of conformity assessment certificate)

Omit “Mutual Recognition Agreement”, substitute “EC Mutual Recognition Agreement or the EFTA Mutual Recognition Agreement”.

3  Subsection 3(1)

Insert:

EC Mutual Recognition Agreement means the Agreement on Mutual Recognition in relation to Conformity Assessment, Certificates and Markings between Australia and the European Community, as in force from time to time.

4  Subsection 3(1)

Insert:

EFTA Mutual Recognition Agreement means the Agreement on Mutual Recognition in relation to Conformity Assessment, Certificates and Markings between Australia and the European Free Trade Association, as in force from time to time.

5  Subsection 3(1)

Insert:

member of EFTA means a country declared by the Minister under section 3A to be a member of the European Free Trade Association.

6  Subsection 3(1) (definition of Mutual Recognition Agreement)

Repeal the definition.

7  Subsection 3A(1)

Repeal the subsection, substitute:

             (1)  The Minister may declare, in writing, that a country specified in the declaration is a member of:

                     (a)  the European Community; or

                     (b)  the European Free Trade Association.

8  Subparagraph 25(2)(a)(i)

After “European Community”, insert “or a member of EFTA”.

9  Subparagraph 26(2)(a)(i)

After “European Community”, insert “or a member of EFTA”.

10  Subparagraph 26A(4)(a)(i)

After “European Community”, insert “or a member of EFTA”.

11  Subsection 61(1) (definition of therapeutic goods information)

Omit “Mutual Recognition Agreement”, substitute “EC Mutual Recognition Agreement or the EFTA Mutual Recognition Agreement”.

 

 

(201/99)


[Minister’s second reading speech made in—

House of Representatives on 25 November 1999

Senate on 6 March 2000]