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 of Level 1, 30 The Bond, 30-34 Hickson Rd Millers Point NSW 2000, to supply specific batches of the products shown in Table 1 below that do not comply with the Therapeutic Goods Order No. 69 – General Requirements for Labelling for Medicines such that the sachets do not include the required prefixes for the batch number and expiry date:
Table 1: Details of affected batches
Product names | Batch numbers | Quantity in Quarantine | Expiry Date |
QUITX STEP 1 NICOTINE PATCHES 21 mg/24 hours, AUST R 77927 | 447700 | 1897 | Jul-13 |
472200 | 12695 | Aug-14 | |
475000 | 35789 | Oct-14 | |
481100 | 43489 | Jan-15 | |
QUITX STEP 2 NICOTINE PATCHES 14mg/24 hours, AUST R 77929 | 457700 | 15866 | Dec-13 |
481000 | 21630 | Jan-15 | |
QUITX STEP 3 NICOTINE PATCHES 7mg/24 hours, AUST R 77930 | 470700 | 13417 | Aug-14 |
Pursuant to section 15(1) of the Act, my consent is subject to the following conditions:
- The products comply with all other aspects of the standard;
2. The affected sachets are marked with actual batch numbers and expiry dates, and
3. This consent applies only to batches shown in Column 2 and the quantity of units shown in Column 3.
(Signed by)
Mayada Kayali
Delegate of the Secretary
Office of Medicines Authorisation
26 November 2012