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

COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

Sections 14 and 14A Notice

On 2 September 2015, a delegate of the Secretary of the Department of Health, on the application of Mallinckrodt Australia Pty Ltd, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the importation and supply of:

• kit for the preparation of technetium (99m Tc) (TECHNESCAN SESTAMIBI) sestamibi injection [AUST R 170503]

that do not conform with the requirements of paragraph 3(2)(l) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines, in that the name and address of the previous sponsor is stated on the labels.

The consent is effective for 12 months from the date of sponsorship transfer, that is, from 14 September 2015 to 13 September 2016.

The consent is subject to the following conditions:

1. The labels to which this consent applies are those currently approved and provided with the application letter.
2. Arrangements are in place with Mallinckrodt (outgoing sponsor) for the referral of any queries or complaints concerning the products to Landauer (incoming sponsor).
3. No other changes have been made.