THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On 19 November 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 29045 doses of TYPHIM Vi 0.025 mg/0.5 ml Salmonella typhi Vi polysaccharide vaccine injection syringe [AUSTR 45073], batch J0036-1 with the Standard Export label; AND
(b) For the syringe labels not to comply with 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 condition:
- Each pack of the product is to be repacked in the Australian approved carton with Australian product information (PI).
2. That each syringe blister tray shall have affixed a sticker with appropriate instructions regarding the route of administration, as provided in your submission.
3. That appropriate samples of the repackaged product be provided to the TGA as part of the normal Vaccine Lot Release process.