COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

Sections 14 and 14A Notice

On 15 December 2015, a delegate of the Secretary of the Department of Health, on the application of GlaxoSmithKline Australia Pty Ltd, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the importation and supply of:

• multi-component Meningococcal B vaccine (recombinant, adsorbed) (BEXSERO)-suspension for injection 0.5 ml pre-filled syringe without needle [AUST R 190718]
• multi-component meningococcal B vaccine (recombinant, adsorbed) (BEXSERO)-suspension for injection 0.5 ml pre-filled syringe with needle [AUST R 190719]

that do not conform with the requirements of paragraph 3(2)(l) of Therapeutic Goods Order Number 69 – General requirements for labels for medicines, in that the products will be supplied in labels containing the name and address of the previous sponsor (Novartis Vaccines and Diagnostics Pty Ltd), rather than the current sponsor (GlaxoSmithKline Australia Pty Ltd.).

The consent is effective from 15 December 2015 until 30 November 2016.

The consent is subject to the following conditions:

1. The labels to which this consent applies are those previously approved for the former sponsor Novartis Vaccines and Diagnostics Pty Ltd, and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to the current sponsor GlaxoSmithKline Australia Pty Ltd.