THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On April 22 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:
- testosterone (ANDRODERM) 12.2 mg per patch transdermal drug delivery system sachet [Aust R 61818]
- testosterone (ANDRODERM) 24.3 mg per day patch transdermal drug delivery system sachet [Aust R 82398]
- oxybutynin (OXYTROL) 3.9 mg/ day transdermal drug delivery system sachet [Aust R 125489]
by Watson Pharma Pty Ltd South Melbourne, VIC (“the Company”);
That does not conform with paragraphs 3(2)(l) of Therapeutic Goods Order (TGO) 69, in that the details of the previous sponsor (Hospira) are listed on the pouch and carton instead of the new sponsor 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:
- This consent applies until the end of August 2013
- The labels to which this consent applies are those previously used by the old sponsor, having Hospira’s details on them.
- No other changes have been made to the products.
- Arrangements are in place for the prompt referral of any complaints or queries concerning the products to be referred to the new sponsor.