COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On 30 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 Pfizer Consumer Healthcare, gave consent to the importation and supply of:
- Centrum Specialist Vision Plus AUST L 224881
that does not conform with the requirements of the section 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’ is more than 120.0% of the stated content on the label.
The consent is effective from the date of this letter until 15 January 2017.
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 135.0% of the stated content on the label;