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 Alphapharm Pty Limited of Level 1, 30 The Bond, 30-34 Hickson Rd Millers Point NSW 2000, to supply two batches of SALPRAZ HEARTBURN RELIEF pantoprazole (as sodium sesquihydrate) 20 mg enteric coated tablet blister pack (AUST R 169504) – ie. batch numbers 110428 and 112309 - that do not comply with the Therapeutic Goods Order No. 69 – General Requirements for Labelling for Medicines such that the blister packs do not include the required prefixes for the batch number and expiry date.
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.
(Signed by)
Mayada Kayali
Delegate of the Secretary
Office of Medicines Authorisation
12 November 2012