THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On 26 October 2012, 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 Sanofi-Aventis Australia Pty Ltd, 12-24 Talavera Road, Macquarie Park, NSW 2113 of IMMUCYST BCG 6.6 – 19.2 x 100000000 CFU powder for injection vial (Aust R 168005), with US packaging under the tradename THERACYS (BCG); AND
(b) For the above product not to comply with Therapeutic Goods Order No 69 – “General Requirements for Labels for Medicines”; AND
(c) For the above product not to comply with the Sterility Test as specified in the default Standard
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 condition:
1 The labels for use are those submitted with the application (the US carton and vial labels), but with an over-sticker containing the Aust R number and the local sponsor name and address on the carton label.
2. Each pack of the product is to be supplied with the Australian product information (PI) together with the “Dear Healthcare Professional” letter, the draft of which was provided to the TGA on 25 October 2012.
3. That this exemption will apply to each lot of TheraCys specifically reviewed by the TGA and subject to the normal Lot Release process.