THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On April 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 products:
- exenatide (BYETTA 5) 5 mg/20 mL (1.2 mL in total) solution for injection multidose cartridge [Aust R 123609]
- exenatide (BYETTA 10) 10 mg/40 mL (2.4 mL in total) solution for injection multidose cartridge [Aust R 123610]
by AstraZeneca Pty Ltd, North Ryde, NSW (“the Company”);
That does not conform with paragraphs 3(2)(l) of Therapeutic Goods Order (TGO) 69, in that the sponsors details on the labels are those of the previous Company, Eli Lilly Australia, rather than the details the current Company, AstraZeneca 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 the end of December 2013.
2. The labels to which this consent applies are those currently used, having the details of a previous sponsor, Eli Lilly Australia.
3. No other changes have been made to the products listed above.
4. Arrangements are in place for the prompt referral of any queries or complaints concerning the products to the new sponsor, AstraZeneca Pty Ltd.