SECTion 14 AND 14A NOTICE
I, Mayada Kayali, delegate of the Secretary to the Department of Health and Ageing for the purposes of sections 14, 14A and 15 of the Therapeutic Goods Act 1989 (‘the Act’) hereby give my consent, pursuant to sections 14 and 14A of the Act, for Johnson & Johnson Pacific Pty Ltd, 45 Jones Street ULTIMO NSW 2007 to supply MYLANTA 2go DOUBLE STRENGTH chewable tablet (reformulation) blister pack (AUST R 118508) whose blister labels do not comply with subclause 3(2)(a) of the Therapeutic Goods Order No. 69 General requirements for labels for medicines in that the product name on the blister label does not include the word “2go”.
Pursuant to section 15(1) of the Act, my consent is subject to the following condition:
- The product complies with all other aspects of the standard.
- The consent applies only to the following batches:
275527, 275525, 276842, 275522, 275523, 276841, 275524, 277142, 277145, 277399, 277400, 277402, 277401, 277144, 277143, 275526, 278156, 278157, 278158, 278159, 278160, 278889, 278888, 278973, 278974, 279096, 279683, 279684, 279685, 279825, 275528, 276345, 275529, 276344, 276421, 276422, 276840, 277487, 277403, 277404, 277488, 277405, 277406, 278071, 277489, 278075, 278072, 278074, 278076, 278073, 278077, 278887, 278885, 278886, 279680, 279681, 279682
(signed by)
Mayada Kayali
Delegate of the Secretary
Office of Medicines Authorisation
16 April 2013