THERAPEUTIC GOODS ACT 1989
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 Meda Pharmaceuticals Pty Ltd to supply AZEP NASAL SPRAY azelastine 128ug/actuation (as hydrochloride) nasal spray (AUST R 104853) whose label does not comply with subclause 3(2)(1) of the Therapeutic Goods Order No 69 – General requirements for medicine labels because if 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 product complies with all other aspects of the standard.
- The consent is given for a period of 6 months from the date of this notice.
- Meda Pharmaceuticals Pty Ltd have arranged for any contacts made in relation to the above products to the previous sponsor’s address (iNova Pharmaceuticals Australia Pty Ltd) to be re-directed to the address of the current sponsor.
(Signed by)
Mayada Kayali
Delegate of the Secretary
Office of Medicines Authorisation
7 June 2013