THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On 12 October 2012, the delegate of the Secretary of the Department of Health and Ageing for the purposes of subsection 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”) gave his consent to:
(a) the supply of the product – HUMIRA adalimumab (rch) 40mg solution for injection pre-filled pen [AUST R 127116], and HUMIRA adalimumab (rch) 40mg solution for injection pre-filled syringe [AUST R 95780] by Abbvie Pty Ltd, Locked Bag 5016, Botany NSW 1455 (“the Company”);
That do not conform with clause 3(2)(l) of Therapeutic Goods Order (TGO) 69, in that the name of the sponsor is not current on the carton labels.
Pursuant to subsection 15(1) of the Act, the consent given by the delegate of the Secretary as described above is subject to the following conditions:
- Consent is given until August 2014.
- The labels to be used are those currently registered for the product.