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

COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

Section 14 and 14A Notice

On 6 February 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 Australia, gave consent to the supply of:

• VIVAXIM 1mL injection syringe composite pack [AUST R 82745]

that does not conform with the requirements of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines, the Clause 3(1)(b)(ii), Clause 3(2)(c), Clause 3(2)(e), Clause 3(2)(j), Clause 3(2)(g) and Clause 3(5)(b)(i), because the product is in the international pack.

The consent applies to batch J5558-1 (Expiry 30 November 2015) with a total of 5,049 doses.

The consent is effective from the date of this letter until 30 November 2015.

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

1. Supply is restricted to the product in the international pack labelling as provided to the TGA;
2. The primary pack will be over stickered with a sticker containing Australian distributor address and ARTG number;
3. The package insert in the international pack will be removed and current Australian Product Information and Consumer Medicines Information will be inserted into each primary pack;
4. Approved storage conditions are to be maintained during the transfer of package insert; and
5. This batch must comply in all other ways with the conditions of registration applying to the Product.