COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On December 17 2014, 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”), by application of Stallergenes Australia Pty Ltd gave consent to the importation and supply of:
ALBUMIN-SALINE diluent [AUST R 32486] that does not conform with the requirements of the Clause 9(3) and (4)/Table(f) of the Therapeutic Goods Order No. 88 – Standards for donor selection, testing and minimising infectious disease transmission via therapeutic goods that are human blood and blood components, human tissues and human cellular therapy products.
The consent is effective from December 17 2014 until further notice.