COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On February 10 2014, 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”) gave his consent to:
(a) the supply of the product:
- ADACEL pertussis vaccine-acellular combined with diphtheria and tetanus toxoids [adsorbed] 0.5 mL injection vial [AUST R 106554]
By Sanofi-Aventis Australia Pty Ltd, SYDNEY, NSW (“the Company”);
With international vial label that does not conform with paragraphs 3(2)(b) AND 3(2)(c) of Therapeutic Goods Order (TGO) 69.
Pursuant to subsection 15(1) of the Act, the consent given by the delegate of the Secretary as described above is subject to the following conditions:
- This exemption applies only to Batch No C4209AL
- The vaccine is packaged in Australian carton label and supplied with Australian PI
- All other conditions for the importation and supply of this batch must be complied with.