THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On February 21 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 podophyllotoxin (WARTEC) 1.5mg/g cream tube[AUST R 78993] by GlaxoSmithKline Australia Pty Ltd, Melbourne VIC (“the Company”);
That does not conform with paragraph 3(3) of Therapeutic Goods Order (TGO) 69, in that the requirements for the particulars to be included on the main label are not fully met. Owing to the fact that the printing on the tubes has been rotated approximately 90 degrees, the text intended for the main panel is around the side of the tube instead of on the flat face.
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 5500 units of batch 040Q with expiry date January 2016.
2. The tube labels to which this consent applies are those provided with the application, where the text intended for the main panel is around the side of the tube instead of on the flat face. Other than orientation, the tube labels are as approved by the TGA.
3. No other changes have been made to the product podophyllotoxin (WARTEC) 1.5mg/g cream [AUST R 78993].