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— p 1282
Administered by: Health
Published Date 22 May 2013
Printed Publication Date 22 May 2013

 

 

THERAPEUTIC GOODS ACT 1989

 

SECTION 14 AND 14A NOTICE

 

 

 

On April 15 2013, the delegate of the Secretary of the Department of Health and Ageing for the purposes of subsection 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”) gave his consent to:

 

(a)   the supply of the products:

·         cephazolin (as sodium) (DBL CEPHAZOLIN SODIUM) 1 g powder for injection vial [Aust R 56374]

·         cefotaxime (as sodium) (DBL CEFOTAXIME SODIUM) for injection 1 g vial [Aust R 78702]

 

by Hospira Australia Pty Ltd Melbourne, VIC (“the Company”);

 

That does not conform with paragraphs 3(2)(l) of Therapeutic Goods Order (TGO) 69, in that the sponsor’s address details are those of the previous sponsor address details not the current sponsor address details.

 

Pursuant to subsection 15(1) of the Act, the consent given by the delegate of the Secretary as described above is subject to the following conditions:

 

1.       The consent to supply applies until August 1 2013.

 

2.       The labels to which this consent applies are the currently used ones, in which the old Mulgrave address is used instead of the current Collins Street address.

3.       No other changes have been made to the products:

·         cephazolin (as sodium) (DBL CEPHAZOLIN SODIUM) 1 g powder for injection vial [Aust R 56374]

·         cefotaxime (as sodium) (DBL CEFOTAXIME SODIUM) for injection 1 g vial [Aust R 78702]

4.       Arrangements are in place for the prompt referral of all customer queries or complaints to be forwarded from the old address to the new address.