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, 96 Merrindale Drive South Croydon VIC 3136 to supply HERRON SENNESOFT tablet blister pack (AUST R 82877) and CHEMISTS’ OWN NATURAL LAXATIVE WITH SOFTENER tablet blister pack (AUST R 90442) that do not comply with the requirements of Therapeutic Goods Order No. 78 in respect of the limits for content of sennosides in the finished product specifications.
Pursuant to section 15(1) of the Act, my consent is subject to the following conditions:
- The limits for content of sennosides in the finished product specifications will be 97.5-110.0% at release and 92.5-110.0% at expiry.
- Other than the exempted limits for content of sennosides (above) the products will comply with all requirements of Therapeutic Goods Order No. 78.
(Signed by)
Mayada Kayali
Delegate of the Secretary
Office of Medicines Authorisation
5 December 2012