THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On July 20 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 product palifermin (KEPIVANCE) 6.25 mg powder for injection vial [Aust R 107304] by Invida Australia Pty Ltd, Chatswood NSW (“the Company”):
That does not conform with the requirements of Therapeutic Goods Order 69, in that the UK-approved labels are used on the cartons and vials, instead of the Australian approved labels.
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:
- Supply is restricted to product in UK approved packaging as provided to the TGA in correspondence from the Company dated April 13 2012.
- A sticker containing the Australian sponsor details and ARTG number will be placed on the packaging.
- An Australian Product Information document will be supplied with each carton.
- Consent will be granted for a period of two years from July 20 2012.