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

COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

Section 14 and 14A Notice

On 18 March 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 Pfizer Consumer Healthcare, gave consent to the importation and supply of batch J82273 of the:

• Centrum Specialist Vision Plus AUST L 224881

that does not conform with the requirements of the 10(b) of the Therapeutic Goods Order No. 78 – Standards for Tablets and Capsules  (TGO 78), in that the content of the active ingredients ‘Lutein’  and  ‘Zeaxanthin’ are each more than 120.0% of the stated content on the label.

The consent is effective from the date of this letter until 31 August 2016.  

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

1. The content of the active ingredient 'Lutein' must be not less than 90.0% and not more than 160.0% of the stated content on the label;
2. The content of the active ingredient ‘Zeaxanthin’ must be not less than 90.0% and not more than 160.0% of the stated content on the label.