THERAPEUTIC GOODS ACT 1989

SECTION 14 AND 14A NOTICE

On August 07 2012, 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 product metaraminol (Metaraminol Sandoz) 10 mg/1 mL (as tartrate) injection ampoule [Aust R 99402] by Sandoz Pty Ltd, Pyrmont NSW (“the Company”):

That does not conform with paragraph 3(2)(l) of the Therapeutic Goods Order 69 in that product labels contain the previous address of the Company, rather than the current address.

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 the end of 2012.

2.       The labels to which this consent applies are those currently used, having the old address details of the Company.

3.       No other changes have been made to the product metaraminol (Metaraminol Sandoz) 10 mg/1 mL (as tartrate) injection ampoule [Aust R 99402].

4.       Procedures are in place for prompt referral of any queries or complaints about the product to the new address.