COMMONWEALTH OF AUSTRALIA
THERAPEUTIC GOODS ACT 1989
SECTIONS 14 and 14A NOTICE
Between 26 October 2010 and 15 November 2010, a Delegate of the Secretary of the Department of Health and Ageing gave consent, pursuant to sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act), to the following:
- The supply, importation of the therapeutic goods or classes of therapeutic goods specified in Column 2 of the Table and with the Australian Register of Therapeutic Goods number (ARTG No.) specified in Column 3 of the Table; and
- Without conforming to those clauses, specified in Column 5 of the Table, of the standard, specified in the Column 4 of the Table otherwise applicable to the goods.
Pursuant to section 15(1) of the Act, consent is subject to the conditions specified in Column 6 of the Table and consent is given for the period specified in Column 7 of the Table, provided all other requirements of the standard are met.
Column 1 | Column 2 | Column3 | Column 4 | Column 5 | Column 6 | Column 7 |
Sponsor | Goods or Classes of Goods | ARTG No. | Standard | Clauses | Conditions | Period for which consent is given |
Wyeth Consumer Healthcare Pty Ltd | Centrum | 75827 | TGO 78 | 11(b) | The limits of content of individual water-soluble vitamins must not be less than 90 per cent and not more than 150 per cent of the stated content. | Until 25 October 2013 |
Wyeth Consumer Healthcare Pty Ltd | Centrum | 75827 | TGO 78 | 11(b) | The limits of content of individual water-soluble vitamins must not be less than 90 per cent and not more than 165 per cent of the stated content. | Until 25 October 2013 |
Wyeth Consumer Healthcare Pty Ltd | Centrum | 75827 | TGO 78 | 11(b) | The limits of content of the active ingredients chromium, molybdenum and selenium must not be less than 90 per cent and not more than 125 per cent of the stated content. | Until 25 October 2013 |
Wyeth Consumer Healthcare Pty Ltd | Centrum | 75827 | TGO 78 | 11(b) | The limits of content of the active ingredients copper and manganese must not be less than 90 per cent and not more than 107.5 per cent of the stated content. | Until 25 October 2013 |
Wyeth Consumer Healthcare Pty Ltd | Centrum | 75827 | TGO 78 | 11(c) | The dissolution of riboflavin and iron must comply with the United States Pharmocopeia-National Formulary chapter <2040>. There are no further dissolution requirements except for folic acid. | Until 25 October 2013 |
Wyeth Consumer Healthcare Pty Ltd | Centrum | 177700 | TGO 69 | 3(1)(b)(ii) | The minimum letter height on the bottle label of the 14 tablet pack must not be less than 1.3 mm. | Until 15 November 2013 |
Wyeth Consumer Healthcare Pty Ltd | Centrum | 177700 | TGO 78 | 11(b) | The limits of content of the active ingredients must comply with the United States Pharmocopeia-National Formulary (USP 33 – NF 28) monograph “Oil- and Water-Soluble Vitamins and Minerals Tablets”. | Until 15 November 2013 |
Wyeth Consumer Healthcare Pty Ltd | Centrum | 177700 | TGO 78 | 11(c) | The dissolution of riboflavin and iron must comply with the United States Pharmocopeia-National Formulary (USP 33 – NF 28) chapter <2040>. There are no further dissolution requirements except for folic acid. | Until 15 November 2013 |