COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On November 25, 2013 the delegate of the Secretary of the Department of Health 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 clozapine (CLOPINE) tablet 200 mg in blister pack [Aust R 95560]
by Hospira Australia, MELBOURNE, VIC (“the Company”);
That do not conform with paragraphs 3(2)(l) of Therapeutic Goods Order (TGO) 69, in that the label includes an incorrect sponsor address.
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:
- The consent applies only to batch 51545 of the product (2959 packs).
- The consent relates only to non-compliance with subclause 3(2)(l) of the Order. All other aspects must comply with the Order.
- The carton label for use is that provided in the Company letter of application.