COMMONWEALTH OF AUSTRALIA
THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On 4th January 2013, the delegate of the Secretary of the Department of Health and Ageing for the purposes of sections 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”) gave his consent to the following:
(a) the supply by Novartis Pharmaceuticals Australia Pty Ltd, PO Box 101, NORTH RYDE NSW 1670 (the Company) of EXTAVIA interferon beta-1b (rbe) 0.25mg (8 million IU) powder for injection vial with diluent syringe (AUST R 160079) ; AND
(b) for the above goods not to conform with the requirements of the Therapeutic Goods Order No 69 - “General Requirements for Labels for Medicines”.
Pursuant to section 15(1) of the Act, the consent given by the delegate of the Secretary as described above is subject to the following conditions:
1. The exemption will apply to one batch of a maximum 200 units only. The details of this batch will be supplied to the TGA when shipped. The outer carton will be the approved Australian specific carton, with only the inner labels being non-compliant.