Consent given pursuant to Sections14 and 14A for the supply of therapeutic goods specified - GlaxoSmithKline Australia

COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

Section 14 and 14A Notice

On 16 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 GlaxoSmithKline Australia, gave consent to the supply of:

• Boostrix 0.5mL injection pre-filled syringe [AUST R 158363]

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)(j), Clause - 3(5)(b)(i) and Clause 3(5)(b)(ii), because the product is in a general export pack.

The consent applies to batches AC37B164BE (Expiry 30 November 2016) and AC37B164BG (Expiry 30 November 2016) with a cumulative total of 20,000 doses.

The consent is effective from the date of this letter until 30 November 2016.

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 general export pack labelling as provided to the TGA;
2. The carton will be over stickered with a sticker containing Australian Sponsor details and ARTG number;
3. The package insert in the export pack will be removed and current Australian Product Information and Consumer Medicines Information will be inserted into each carton;
4. Approved storage conditions are to be maintained during the transfer of package insert; and
5. These batches must comply in all other way with the conditions of registration applying to this product.