The Parliament of the

Commonwealth of Australia

HOUSE OF REPRESENTATIVES

Presented and read a first time

Therapeutic Goods Amendment Bill 1999

No. , 1999

(Health and Aged Care)

A Bill for 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

ISBN 0642 418446

Contents

A Bill for 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

The Parliament of Australia enacts:

1 Short title This Act may be cited as the Therapeutic Goods Amendment Act 1999.

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3 Schedule(s) Each Act that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms.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 1--Amendment 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".