Consent given pursuant to sections 14 and 14A for the importation and supply of the therapeutic goods specified - Novartis Influenza Vaccines Pty Ltd.

COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

Section 14 and 14A Notice

On 27 March 2015, 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”), on the application of Novartis Influenza Vaccines Pty Ltd, gave consent to the importation and supply of

• AGRIPPAL inactivated influenza (surface antigen) vaccine injection pre-filled syringe with needle [AUST R 144670]

 that does not conform with the requirements of subclause 3(2)(l) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines, in that the carton label states the previous sponsor name.

The consent is effective from the date of this letter until 31st March 2016.

The delegate of the Secretary, under subsection 15(1) of the Act, made the consent subject to the following conditions:

1. The labels to which this consent applies are those currently approved for the former sponsor Novartis Vaccines and Diagnostics Pty Ltd and arrangements are in place that any correspondence concerning the products will be promptly referred from the former sponsor (Novartis Vaccines and Diagnostics Pty Ltd) to the current sponsor (Novartis Influenza Vaccines Pty Ltd).