THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On July 2, 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 fentanyl (as citrate)(DBL FENTANYL) 500 mg /10 mL injection in ampoules [Aust R 107027]
by Hospira Australia Pty Ltd, Melbourne, VIC (“the Company”);
That does not conform with paragraphs 3(2)(l) of Therapeutic Goods Order (TGO) 69, in that the sponsor address details on the labels of the ampoules 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:
- This consent applies only to batch 205072.
2. The labels for use are those submitted with the application, viz labels bearing the previous address details of the Company.
3. No other changes have been made to the product, fentanyl (as citrate) (DBL FENTANYL)
500 mg /10 mL injection in ampoules [Aust R 107027].
4. Details of the process in place to ensure continuous customer contact with the Company are as described in the Company letter dated May 15, 2013.