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 Merck Sharp & Dohme (Australia) Pty Limited, Level 4, 66 Waterloo Road NORTH RYDE NSW 2113 to supply the batches of goods listed in the table below that do not comply with subclause 3(2)(l) of the Therapeutic Goods Order No. 69 – General requirements for medicine labels because their labels do not include the name and address of the current sponsor or supplier of the goods.
Batches of products to which this notice applies
Name of the goods | Batch number(s) |
Aerius 5 mg tablets AUST R 91116 | 1STBAAUA01, 2STBAAEB01 |
Drixine Adult Spray 15 mL AUST R 161596 | 2APMB08A, 2APMB10A |
Drixine No Drip Nasal Spray 15 mL AUST R 166852 | 2E01CP |
Drixine No Drip Moisturising Nasal Spray AUST R 179875 | 2K02ACP |
Drixine No Drip Menthol Nasal Spray AUST R 181889 | 2A03CP |
Children’s Claratyne chewable grape tablets AUST R 169329 | 2HLC4 |
Demazin Cold & Flu tablets AUST R 94036 | BJ382 |
Demazin Cough, Cold & Flu tablets AUST R 97031 | BC835, BM350 |
Demazin Day & Night Cold & Flu tablets AUST R 133205 | BK639 |
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 Therapeutic Goods Order No. 69 – General requirements for medicine label;
2. The product labels include the name and address of the previous sponsor Shering-Plough Pty Ltd; and
3. Merck Sharp & Dohme (Australia) Pty Limited have arranged for any contacts made in relation to the above products to the Shering-Plough Pty Ltd address to be re-directed to the address of the current sponsor.
(Signed by)
Mayada Kayali
Delegate of the Secretary
Office of Medicines Authorisation
1 February 2013