THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On July 23, 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 product – carmustine (BICNU) 100 mg powder for injection vial with ampoule [Aust R 157781]
by Watson Pharma, Sydney, NSW (“the Company”);
That does not conform with paragraphs 3(2)(l) of Therapeutic Goods Order (TGO) 69, in that the details of the old sponsor (Bristol-Myers Squibb Australia Pty Ltd) is used instead of the details of the new sponsor, Watson Pharma Pty Ltd.
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:
- The consent applies until November 21, 2013.
- The labels for use are those submitted with the application, viz labels bearing having the old sponsor details.
- No other changes have been made to the product.
- Details of the process in place to ensure continuous customer contact with the Company are as described in the letter of May 21, 2013.