COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Sections 14 and 14A Notice
On 24 December 2015, a delegate of the Secretary of the Department of Health, on the application of GlaxoSmithKline Australia Pty Ltd, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the importation and supply of:
- rabies virus vaccine (Inactivated) (RABIPUR) 2.5 IU powder for injection vial with diluent ampoule [AUST R 100582]
that do not conform with the requirements of the paragraph 3(2)(l) of Therapeutic Goods Order Number 69 – General requirements for labels for medicines, in that the product will be supplied in labels containing the name and address of the previous sponsor (CSL Biotherapies), rather than the current sponsor (GlaxoSmithKline Australia Pty Ltd).
The consent is effective from 24 December 2015 until 30 November 2016.
The consent is subject to the following conditions:
- The labels to which this consent applies are those previously approved for the former sponsor, CSL Biotherapies, and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the product to the current sponsor GlaxoSmithKline Australia Pty Ltd.