COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
I, Mayada Kayali, Delegate of the Secretary to the Department of Health 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 Meda Pharmaceuticals Pty Ltd Level 20 Tower A The Zenith Centre 821 Pacific Highway CHATSWOOD NSW 2067 to supply Waxsol Ear Drops liquid bottle (AUST R 18662) that does not comply with subclause 3(2)(l) of the Therapeutic Goods Order No. 69 – General requirements for medicine labels because its 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 condition:
- The medicine complies with all other aspects of the standard.
- The exemption applies only until 31 March 2014.
- Arrangements are in place for all contacts made to Norgine Pty Ltd in relation to this medicine to be re-directed to Meda Pharmaceuticals Pty Ltd.
(Signed by)
Mayada Kayali
Delegate of the Secretary
Office of Medicines Authorisation
24 October 2013