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 Norgine Pty Ltd, 3/14 Rodborough Road Frenchs Forest NSW 2086, to supply MOVICOL JUNIOR CHOCOLATE powder for solution sachet (AUST R 207698) whose label does not include the quantity of sodium per maximum recommended daily dose required by subclause 3(2)(d) of the Therapeutic Goods Order No. 69 – General requirements for medicine labels.
Pursuant to section 15(1) of the Act, my consent is subject to the following condition:
- The product complies with all other aspects of the Therapeutic Goods Order No. 69 – General requirements for medicine label.
(Signed by)
Mayada Kayali
Delegate of the Secretary
Office of Medicines Authorisation
8 April 2013