COMMONWEALTH OF AUSTRALIA
Department of Health and Ageing
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On August 8, 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 prepandemic (AFLUNOV) influenza vaccine H5N1 [surface antigen, inactivated, adjuvanted] 0.5 mL pre-filled syringe [Aust R 167943], by Novartis Vaccines and Diagnostics NORTH RYDE, NSW (“the Company”);
That do not conform with paragraphs 3(2)(b) of Therapeutic Goods Order (TGO) 69, in that the name(s) of all active ingredients in the goods do not appear on the label.
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 indefinitely.