COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Sections 14 and 14A Notice
On 3 August 2015, a delegate of the Secretary of the Department of Health, on the application of Sanofi Pasteur Australia Pty Ltd, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the importation and supply of:
- pertussis vaccine-acellular (ADACEL) combined with diphtheria and tetanus toxoids (adsorbed) 0.5mL injection vial [AUST R 106554]
that do not conform with the requirements of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines (TGO 69), lot C4771AA (expiry June 2017) and lot C4816AE (expiry August 2017) in that the vials use international labels instead of the Australian registered label.
The consent is effective from3 August 2015.
The consent is subject to the following conditions:
- a ‘Dear Healthcare Provider’ letter identical to that provided to the Therapeutic Goods Administration as part of the original submission on 8 July 2015 (TRIM ref: R15/613250) will be supplied with each affected batch warning that the age indication on the international vial is incorrect;
- the vials will be repacked into the approved Australian carton together with the approved Australian Product Information leaflet at the site the Company have proposed in the letter dated 8 July 2015; and
- lot C4771AA (expiry June 2017) and lot C4816AE (expiry August 2017) comply with the Australian registered details for the product notwithstanding they are packaged with an international vial label.