COMMONWEALTH OF AUSTRALIA
THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
I, Chris Rolls delegate of the Secretary of 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 CSL Limited to supply Oral inactivated cholera vaccine (DUKORAL, AUST R 94483) Lot Nos KV2354A1, KV2354A2, KV2357A1, KV2357A2, KV2357B2 and KV2361A1 with labels which do not comply with paragraph 3(2)(h) of Therapeutic Goods Order No 69 - “General Requirements for Labels for Medicines”.
Pursuant to section 15(1) of the Act, my consent is subject to the following conditions:
1. This exemption is only for the specified lots.
2. The consent relates only to paragraph 3(2)(h) of Therapeutic Goods Order 69 and that all
other parts must be complied with.
Supply of this product is subject to the standard conditions applying to the supply of goods registered in the Australian Register of Therapeutic Goods.
(signed by)
Chris Rolls
Delegate of the Secretary
Office of Laboratories and Scientific Services
15 July 2013