Supply of QUADRACEL pertussis vaccine-acellular and diphtheria and tetanus toxoids (adsorbed) combined with inactivated poliovirus types 1,2, and 3 (MRC-5 cells) by Sanofi-Aventis Australia Pty Ltd

COMMONWEALTH OF AUSTRALIA

Department of Health

Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

SECTION 14 AND 14A NOTICE

On 27 November 2013, the delegate of the Secretary of the Department of Health 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, Talavera Corporate Centre, Building D, 12-24 Talavera Road, Macquarie Park, NSW 2113 (the Company) of  QUADRACEL pertussis vaccine-acellular and diphtheria and tetanus toxoids (adsorbed) combined with inactivated poliovirus types 1,2, and 3 (MRC-5 cells)  Aust R 91355 AND

(b)  for the above goods not to conform with the requirements of the European Pharmacopoeia.

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 conditions:

1. This exemption applies only to 50,000 doses from QUADRACEL Final Bulk Lot C4338 (Expiry 31 May 2015);
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.