Consent given pursuant to sections 14 and 14A to the importation and supply of the therapeutic goods specified by Sanofi Pasteur Australia

COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

Sections 14 and 14A Notice

On 21 December 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 (TRIPACEL) - acellular combined with diphtheria and tetanus toxoids (adsorbed) 0.5 mL injection vial [AUST R 63120]

that do not conform with the requirements of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines, in that the product name is not on the label. The approved US name, Daptacel will be on the vial labels rather than the Australian registered Tripacel and 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 is effective from 21 December 2015 until the batch number is exhausted.

The consent is subject to the following conditions:

1. A ‘Dear Healthcare Professional’ letter identical to that provided to the Therapeutic Goods Administration (TGA) on 11 December 2015 will be supplied with each affected batch warning that the age indication on the US vial is incorrect;
2. The vials will be repacked into the approved Australian carton together with the approved Australian Product Information leaflet at the site you have proposed in the letter dated 19 November 2015;
3. The company will provide TGA with a copy of the CBER Release Certificate from the FDA relating to the above batch and
4. Normal TGA lot release processes will apply to this batch except that the US lot release protocol is different from the Australian version.