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 Pfizer Australia Pty Ltd of Unit 21B, 1 Maitland Place, Norwest Business Park, Baulkham Hills NSW 2153, to supply three batches of DIMETAPP DAYTIME/NIGHTIME LIQUID CAPS capsule blister pack (AUST R 137255) – ie. batch numbers C8787A, C8787B and C8779 – that do not comply with Therapeutic Goods Order No. 69 – General Requirements for Labelling for Medicines such that the blister packs include the name of the previous sponsor (Wyeth) of the product and not the current sponsor (Pfizer).
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
14 November 2012