COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Sections 14 and 14A Notice
On 12 November 2015, a delegate of the Secretary of the Department of Health, on the application of Schulke Australia Pty Ltd, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the supply of
- MICROSHIELD ANGEL BLUE ANTIMICROBIAL HAND GEL (AUST R 205184)
that does not conform with the requirements of the subclause 3(2)(d) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines in that the label for the product does not include a statement indicating that the product contains tartrazine.
The consent applies to batches 1035261, 1036163, 1036164, 1036167, 1038499, 1039214, 1039213, 1039123 and 1039121 but only until 1 November 2016.
The consent is subject to the following condition:
- A ‘Dear Healthcare Professional’ letter identical to that provided to the TGA on 10 November 2015 will be issued to all current customers.