COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Sections 14 and 14A Notice
On 7 January 2016, a delegate of the Secretary of the Department of Health, on the application of Pfizer Australia Pty Ltd, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the importation and supply of
- meningococcal group c polysaccharide conjugate vaccine suspension (NEISVAC-C VACCINE) for injection syringe [AUST R 83093]
that do not conform with the requirements of paragraph 3(2)(l) of the 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 (Baxter Healthcare Pty Ltd), rather than the current sponsor (Pfizer Australia Pty Ltd).
The consent is effective from 7 January 2016 until 30 July 2016.
The consent is subject to the following conditions:
- The labels to which this consent applies are those previously approved for the former sponsor, Baxter Healthcare Pty Ltd, 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 Pfizer Australia Pty Ltd.