COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On 30 January 2015, the delegate of the Secretary of the Department of Health for the purposes of subsection 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”), on the application of Sanofi Pasteur, Talavera Corporate Centre, Building D, 12-24 Talavera Road, Macquarie Park NSW 2113 (“the Company”), gave consent to the supply of:
- ACAM2000 smallpox vaccine - diluent component [AUST R 153108] that does not conform with the requirements of the 3(2)(j) , 3(2)(l) , 3(2)(n) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines, in that labelling is specifically designed for supply to the US Centers for Disease Control with US labelling which is not approved by TGA.
The consent is effective from the date of this letter until 31 July 2015.
The delegate of the Secretary, under subsection 15(1) of the Act, made the consent subject to the following condition:
- This exemption applies only to the national stockpile held by the Australian Government Department of Health