Commonwealth of Australia Explanatory Memoranda

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THERAPEUTIC GOODS AMENDMENT BILL (NO. 3) 2006

                             2004-2005-2006




 THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA




                   HOUSE OF REPRESENTATIVES




    THERAPEUTIC GOODS AMENDMENT BILL (No.3) 2006




                  EXPLANATORY MEMORANDUM




(Circulated by authority of the Parliamentary Secretary to the Minister for
             Health and Ageing, the Hon Christopher Pyne)
THERAPEUTIC GOODS AMENDMENT BILL (No.3) 2006

OUTLINE
This Bill proposes to amend section 37 of the Therapeutic Goods Act 1989 to provide for
applications for manufacturing licences to manufacture medicines, blood and tissues to be
lodged electronically. This amendment will make section 37 consistent with other similar
provisions in the Act that permit or require applications lodged for various purposes to be
done electronically, using software that is compatible with the systems used by the
Department.


FINANCIAL IMPACT STATEMENT
There is no financial impact.




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THERAPEUTIC GOODS AMENDMENT BILL (No.3) 2006

NOTES ON CLAUSES

Clause 1 - Short title
This clause provides for the Act to be cited as the Therapeutic Goods Amendment Act (No.3)
2006.

Clause 2 - Commencement
This clause provides that the Act will commence to operate from the date it receives the
Royal Assent.

Clause 3 - Schedule(s)
Clause 3 has the effect of amending the Therapeutic Goods Act 1989 (the Act) in the manner
specified in Schedule 1.

Schedule 1 - Amendments

Therapeutic Goods Act 1989
Item 1 - Paragraph 37(1)(a)
Subsection 37(1) of the Act currently requires a manufacturer of medicines, blood or tissues
to lodge an application in writing in accordance with a form approved by the Secretary of the
Department of Health and Ageing (the Secretary). This item omits the words "in writing" to
accommodate the amendment that will enable the Secretary to permit or require that
applications be lodged electronically.

Item 2 - new subsection 37(3)
This Item inserts new subsection 37(3) to provide that where the Secretary determines the
form of applications to be lodged by manufacturers who wish to manufacture medicines,
blood or tissues, or when the Secretary seeks further information to support such an
application, the Secretary may permit or required that the application or information be
lodged in accordance with specified software requirements.




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