THERAPEUTIC GOODS ACT 1989
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 Alphapharm Pty Limited to supply QUITX STEP 1 NICOTINE PATCHES 21mg/24 hours nicotine 52.5mg transdermal drug delivery system (AUST R 77927) whose labels do not comply with subclause 3(12)(b) of the Therapeutic Goods Order No. 69 General requirements for labels for medicines in that the batch and expiry details on the sachet labels are not prefixed with the required prefixes.
Pursuant to section 15(1) of the Act, my consent is subject to the following conditions:
- The goods comply with all other aspects of the standard.
2. The consent applies only to batch 489800 that expires in October 2015.
(Signed by)
Mayada Kayali
Delegate of the Secretary
Office of Medicines Authorisation
7 June 2013