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 of Demazin Day & Night Cold & Flu tablets AUST R 133205 whose label does not comply with subclause 3(2)(l) of the Therapeutic Goods Order No. 69 – General requirements for medicine labels in that the label does not include the name and address of the current sponsor or supplier of the goods.
Pursuant to section 15(1) of the Act, my consent is subject to the following conditions:
- The consent applies to batch number BR961 only;
2. The product complies with all other aspects of the Therapeutic Goods Order No. 69 – General requirements for medicine label;
3. The product labels include the name and address of the previous sponsor Shering-Plough Pty Ltd; and
4. 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
19 April 2013