COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On 14 April 2015, the delegate of the Secretary of the Department of Health for the purposes of subsection 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”), on the application of GlaxoSmithKline Australia Pty Ltd, gave consent to the importation and supply of:
- INFANRIX 0.5mL injection syringe [AUST R 142370]
that does not conform with the requirements of subclauses 3 (2)(b)&(c) of the Therapeutic Goods Order 69 General Requirements for labels for medicines, in that the syringe label does not include the names of all active ingredients and the quantity of all active ingredients.
The consent is effective from the date of this letter until 14 April 2018.