Consent given pursuant to sections 14 and 14A for the supply of the Therapeutic Goods specified - between 1 October 2014 and 30 September 2015

COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

Section 14 and 14A Notice

On October 1, 2014, 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”), by application of Hospira Australia Pty Ltd, gave consent to the supply, of:

DBL Heparin Sodium (PORCINE MUCOUS) 35000 IU/ 35 mL injection BP vial [AUST R 16345] that does not conform with the requirements of subclause 3(1)(b)(ii) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines in that the vial label failed to meet the 1.5 mm height requirements.

The consent is effective from October 1, 2014 until September 30, 2015.

The delegate of the Secretary has, under subsection 15(1) of the Act, made the consent subject to the following conditions:

1. The labels to which this consent applies are those previously approved and arrangements are in place for the prompt referral of any queries or complaints concerning the products to the current sponsor.