Consent given pursuant to Sections 14 and 14A to the importation and supply of the therapeutic goods specified by Pfizer Australia

COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

Sections 14 and 14A Notice

On 1 December 2015, a delegate of the Secretary of the Department of Health, on the application of Pfizer Australia Pty Ltd, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the importation and supply of

• Centrum Multiplus Men Total Supplement Kit – AUST L 245812;
• Centrum Multiplus Women Total Supplement Kit – AUST L 247392

that do not conform with the requirements of the section 10(b) of the Therapeutic Goods Order No. 78 – Standards for Tablet and Capsules (TGO 78), in that the content of the active ingredients ‘Lutein’ and Lycopene’ are each more than 120.0 per cent of the stated content on the label.

The consent is effective from the date of this decision letter until 1 December 2016.  

The consent is subject to the following conditions:

1. The content of the active ingredient ‘Lutein’ must be not less than 90.0 per cent and not more than 135.0 per cent of the stated content on the label;
2. The content of the active ingredient ‘Lycopene’ must be not less than 90.0 per cent and not more than 140.0 per cent of the stated content on the label.