THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On September 13 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 following products by Hospira Australia Pty Ltd, Melbourne Vic (“the Company”):
- leuprorelin acetate (Eligard) 45 mg modified release injection syringe [Aust R 101581]
- leuprorelin acetate (Eligard) 7.5 mg modified release injection syringe [Aust R 97449]
- leuprorelin acetate (Eligard) 22.5 mg modified release injection syringe [Aust R 97450]
- leuprorelin acetate (Eligard) 30 mg modified release injection syringe [Aust R 97451]
That do not conform with paragraph 3(2)(l) of the Therapeutic Goods Order 69, in that the previous address of the sponsor is listed on the carton labels 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:
- The consent applies until December 31 2012.
- The labels to be used are identical to those submitted by the Company in correspondence dated August 28 2012, viz labels bearing the previous address details of the Company.
- No other changes have been made to the products:
- leuprorelin acetate (Eligard) 45 mg modified release injection syringe [Aust R 101581]
- leuprorelin acetate (Eligard) 7.5 mg modified release injection syringe [Aust R 97449]
- leuprorelin acetate (Eligard) 22.5 mg modified release injection syringe [Aust R 97450]
- leuprorelin acetate (Eligard) 30 mg modified release injection syringe [Aust R 97451]
4. Details of the process in place to ensure continuous customer contact with the Company are as described in electronic email received from the Company on September 12 2012.