COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Sections 14 and 14A Notice
On 8 October 2015, a delegate of the Secretary of the Department of Health, on the application of Johnson & Johnson Pacific Pty Ltd, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the supply of:
- MYLANTA ORIGINAL oral liquid bottle [AUST R 122007]
- MYLANTA P ANTACID oral liquid bottle [AUST R 121994]
that do not conform with the requirements of section 8 of the Therapeutic Goods Order No. 77 - Microbiological Standards for Medicines, for compliance with USP test <51> Antimicrobial Effectiveness Testing in regards to P. aeruginosa.
The consent is effective from 8 October 2015 until 13 September 2018.
The consent is subject to the following conditions:
- The products comply with all other applicable requirements of Therapeutic Goods Order No. 77- Microbiological Standards for Medicines.