COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
On 5 November 2013 the delegate of the Secretary of the Department of Health 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 Novartis Vaccines and Diagnostics Pty Ltd, 54 Waterloo Road, North Ryde, NSW 2113(the Company) of AGRIPPAL inactivated influenza (surface antigen) vaccine injection pre-filled syringe (with needle) - Aust R 144670
(b) for the above goods not to conform with the requirements of the Therapeutic Goods Order No 69 - “General Requirements for Labels for Medicines” – clause 3(1)b(ii) regarding the minimum letter height of the Sponsor name on the syringe label and clause 3(2)b regarding the listing of all active ingredients on the syringe label, due to the space constraints of the syringe label.