Consent given pursuant to Sections 14 and 14A to the importation and supply of the therapeutic goods specified by Biogen Australia Pty Ltd

COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

Sections 14 and 14A Notice

On 11 December 2015, a delegate of the Secretary of the Department of Health, on the application of Biogen Australia Pty Ltd, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the importation and supply of

• Fampridine (FAMPYRA) 10 mg modified release tablets bottle [AUST R 170002].

that do not conform with the requirements of the paragraph 3(2)(l) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines , in that the carton label of the products include the sponsor’s old address and/or name.

The consent is effective from 11 December 2015 until nominated batches are exhausted or have expired.

The consent is subject to the following conditions:

1. The carton labels to which this consent applies are those approved for use currently.