Consent given pursuant to Sections 14 and 14A for the importation and supply of the therapeutic goods specified - Sanofi Pasteur

COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

Section 14 and 14A Notice

On 22 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, gave consent to the importation and supply of:

• Quadracel [AUST R 91355] that does not conform with the requirements of the, European Pharmacopoeia, in that it is tested to United States, rather than Australian, specifications, as detailed in the application letter.

The consent applies to batch C4798AA but only until the expiry of the lot, March 2017. 

The delegate of the Secretary, under subsection 15(1) of the Act, made the consent subject to the following conditions:

1. This consent applies only to 60000 doses from Quadracel final bulk lot C4798 (expiry March 2017);
2. The doses will be labelled in the Australian approved labels (carton, vial and package insert);
3. The company will provide TGA with a copy of the Release Certificate from Biologics and Genetic Therapies Directorate, Canada relating to the above batch; and
4. Normal TGA lot release processes will apply to this batch.