THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On December 7 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 meningococcal (Groups A, C, W-135 and Y) oligosaccharide CRM197 (MENVEO) conjugate vaccine powder and solution for injection vials [Aust R 192696] by Novartis Vaccines and Diagnostics Pty Ltd, North Ryde, NSW (“the Company”):
That does not conform with paragraph 3(2)(b) and 3(2)(l) of Therapeutic Goods Order 69, in that the active ingredients and sponsor name does not appear on the Groups C, W-135 and Y (MenCWY) vial labels, and the active ingredient does not appear on the Group A (MenA) vial labels.