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, Level 1, 30 The Bond, 30-34 Hickson Road MILLERS POINT NSW 2000 to supply the following goods 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:
AUST R 77927 QUITX STEP 1 NICOTINE PATCHES 21mg/24 hours nicotine 52.5mg
AUST R 77929 QUITX STEP 2 NICOTINE PATCHES 14mg/24 hours nicotine 35mg
AUST R 77930 QUITX STEP 3 NICOTINE PATCHES 7mg/24 hours nicotine 17.5 mg
Pursuant to section 15(1) of the Act, my consent is subject to the following condition:
- The goods comply with all other aspects of the standard.
- The consent applies only to batch numbers 489800, 497900, 497300 and 480400.
(Signed by)
Mayada Kayali
Delegate of the Secretary
Office of Medicines Authorisation
10 July 2013