Supply of Mylanta Original and Mylanta P Antacid (Johnson & Johnson)

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:

-         to the supply by Johnson & Johnson Pacific Pty Ltd Locked Bag 5 BROADWAY NSW 2007 of MYLANTA ORIGINAL oral liquid bottle (AUST R 122007) and MYLANTA P ANTACID oral liquid bottle (AUST R 121994); and

-         for the goods not to conform with the requirements of section 8 of the Therapeutic Goods Order No. 77 - Microbiological Standards for Medicines with regard to P. aeruginosa.

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

1. The goods comply with all other applicable requirements of Therapeutic Goods Order No. 77- Microbiological Standards for Medicines.
2. The consent is valid only for 3 years from the date of this notice.

(Signed by)

Mayada Kayali

Delegate of the Secretary

Office of Medicines Authorisation

13 January 2014