SECTion 14 AND 14A NOTICE
I, DR 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 Johnson & Johnson Pacific Pty Ltd, Locked Bag 5 BROADWAY NSW 2007 to supply BENADRYL ORIGINAL oral liquid bottle (AUST R 14114) that does not comply with Preservative Efficacy Test for Aspergillus niger specified in Section 8 of the Therapeutic Goods Order No. 77 Microbiological Standards for Medicines.
Pursuant to section 15(1) of the Act, my consent is subject to the following conditions:
- The exemption is given only until June 2013.
- The product complies with all other aspects of the Therapeutic Goods Order No. 77 Microbiological Standards for Medicines.
(Signed by)
DR MAYADA KAYALI
Delegate of the Secretary
Office of Medicines Authorisation
16 October 2012