Supply of INTANZA influenza vaccine split virion inactivated 9 microgram/strain/0.1mL suspension for injection pre-filled syringe by Sanofi-Aventis Australia Pty Ltd

COMMONWEALTH OF AUSTRALIA

THERAPEUTIC GOODS ACT 1989

SECTION 14 AND 14A NOTICE

On 9 May 2013 a delegate of the Secretary of the Department of Health and Ageing for the purposes of sections 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”) gave consent to the following:

(a)   the supply by Sanofi-Aventis Australia Pty Ltd, Macquarie Park  NSW  2113 (the Company) of INTANZA influenza vaccine split virion inactivated 9 microgram/strain/0.1mL suspension for injection  pre-filled  syringe [AUSTR 150130];

AND

(b)  for the above goods not to conform with the requirements of Therapeutic Goods Order No. 69 (General requirements for labels for medicine, TGO 69) , being supplied in Standard International Labels for the syringe label.

Pursuant to section 15(1) of the Act, the consent given by the delegate of the Secretary as described above is subject to the following conditions:

1. The tamper-evident syringe trays are repackaged in the Australian carton with the Australian Product Information (PI).

2.       That this exemption will apply only to Intanza Batch K8103-3, expiry 31 December 2013.