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 Aspen Pharma Pty Ltd, 34–36 Chandos Street, St Leonards NSW 2065 to supply COLOXYL WITH SENNA FILM COATED TABLETS bottle (AUST R 59118), AMCAL SENNA-COL film coated tablets bottle (AUST R 81753), and GUARDIAN SENNA-COL film coated tablets bottle (AUST R 139220) that do not comply with the requirements of Therapeutic Goods Order No. 78 in respect of the limits for content of sennosides and for content of docusate sodium in the finished product specifications.
Pursuant to section 15(1) of the Act, my consent is subject to the following conditions:
(Signed by)
Mayada Kayali
Delegate of the Secretary
Office of Medicines Authorisation
11 December 2012