Supply of Chloromycetin Eye Ointment by Pfizer Australia

COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

SECTION 14 AND 14A NOTICE

I, Mayada Kayali, Delegate of the Secretary to the Department of Health 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  Pfizer Australia Pty Ltd 38-42 Wharf road West Ryde NSW 2114 to supply CHLOROMYCETIN eye ointment (AUST R 56589) that does not comply with subclause 3(11) of the Therapeutic Goods Order No. 69 – General requirements for medicine labels because the batch number on the tube label does not include the batch number prefix.

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

1. The medicine complies with all other aspects of the standard.
2. The exemption applies to the following batches of the medicine only:

Batch 073081 Expiry date July 2016

Batch 073082 Expiry date July 2016

(Signed by)

Mayada Kayali

Delegate of the Secretary

Office of Medicines Authorisation

11  December 2013