Supply of Polibar Acb Disposable Barium Enema Kit by Bracco Pty Ltd

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 Bracco Pty Ltd, PO Box 424

LINDFIELD NSW 2070 to supply POLIBAR ACB DISPOSABLE BARIUM ENEMA KIT Barium sulfate 965 mg/g powder for suspension (AUST R 205118) that does not comply with the shelf-life limit for loss on drying of not more than 1% specified by the Barium sulphate for suspension monographs of both the British Pharmacopoeia and the United States Pharmacopoeia, which are default standards for the purposes of the Act.  

Pursuant to section 15(1) of the Act, my consent is subject to the following conditions:

1. The product complies with all other aspects of the standard,
2. The product complies with the limit of not more than 1% loss on drying at release, and
3. The product complies with the limit of not more than 1.5% loss on drying at the end of its shelf-life.

(Signed by)

Mayada Kayali

Delegate of the Secretary

Office of Medicines Authorisation

1 February 2013