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 VAXIGRIP INFLUENZA VACCINE (split virion) 0.5mL injection syringe [AUSTR 80198];
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 both the outer carton and 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 labels for use are those submitted with your application, with an over-sticker containing the Aust R number and the local sponsor name and address on the carton label.
2. Each pack of the product is to be supplied with the Australian Product Information (PI).
3. That this exemption will apply to 3 batches only:
Vaxigrip Batch K7009-1, expiry 31 December 2013 – 36,307 doses
Vaxigrip Batch K7009-2, expiry 31 December 2013 – 13,693 doses
Vaxigrip Batch K7071-1, expiry 31 January 2014 – 33,369 doses