COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On 1 December 2014 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 Vaccines and Diagnostics Pty Ltd, 54 Waterloo Road, North Ryde, NSW 2113(the Company) 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 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.
The consent is effective from 1 December 2014 until 31 December 2015.
The delegate of the Secretary, under subsection 15(1) of the Act, made the consent subject to the following conditions:
- The product/s in relation to which this consent is given must comply with all other applicable parts of Therapeutic Goods Order 69 and other applicable standards.