COMMONWEALTH OF AUSTRALIA
THERAPEUTIC GOODS ACT 1989
SECTIONS 14 and 14A NOTICE
Between 13 September 2010 and 8 March 2011 the 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 Advance Tablet | 172060 | TGO 78 | 10(b) | Such that the upper limits of the active ingredients lutein and lycopene arenot more than 165% of the stated content, rather than the required 120%. | Until further notice. |
Health World Limited | Ethical Nutrients Chromium Sugar Balance | 171147 | TGO 78 |
| Such that the upper limit of R,S-alpha lipoic acid in the product is not more that 130% of the stated content, rather than the required 120%. | For a period of twelve (12) months from 11 October 2010. |
Blackmores Limited | Blackmores Teen Multi + brain nutrients Mind & Body development for Guys | 164365 | TGO 69 | 3(2)(g) | The label includes the advisory statement ‘The recommended daily amount of vitamin A from all sources is 900 micrograms retinol equivalents for men’. | Until further notice |
Nestle Confection-ery and Snacks Company | Walco Chewy Quick Eze | 66995 | TGO 78 | 8(a)(i) | Such that the goods conform to the British Pharmacopoiea (BP) requirements for Uniformity of Dosage units by mass variation rather than the BP requirements for Uniformity of Weight (Mass). | Until further notice |
Nestle Confection-ery and Snacks Company | Chewy Quick Eze Forest Berry | 113992 | TGO 78 | 8(a)(i | Such that the goods conform to the British Pharmacopoiea (BP) requirements for Uniformity of Dosage units by mass variation rather than the BP requirements for Uniformity of Weight (Mass). | Until further notice |
Nestle Confection-ery and Snacks Company | Chewy Quick Eze Orange | 152090 | TGO 78 | 8(a)(i | Such that the goods conform to the British Pharmacopoiea (BP) requirements for Uniformity of Dosage units by mass variation rather than the BP requirements for Uniformity of Weight (Mass). | Until further notice |
Health One Pty Ltd | Ultravision Tablets | 174623 | TGO 78 | 10(b | Such that the upper limit of lutein in the batch #12286A of the product is not more than 138% of the stated content, rather than the required 120%. | For a period of twelve (12) months from 24 January 2011. |
Wyeth Consumer Healthcare Pty Ltd | Centrum | 75827 | TGO 69 | 3(2)(d) | Such that the label of the bottle containg the goods (the primary packaging) does not include the required advisory statement “Contains sorbic acid”, provided the label statement is included on the carton (secondary packaging) for batches E21274, E21285, E21913, E21289 and E21363. | Until batches have been exhausted. |
Integria Healthcare Australia Pty Ltd | Greenridge Liverplex tablet | 177684 | TGO 78 | 10(d) | Such that maximum disintegration time for the tablets, using the relevant test for disintegration of uncoated tablets in the British Pharmacopoiea general monograph “Tablets”, is 30 minutes rather than the required 15 minutes. |
|
Integria Healthcare Pty Ltd | Mediherb Siberian Ginseng | 92074 | TGO 78 |
| Such that maximum disintegration time for the tablets, using the relevant test for disintegration of uncoated tablets in the British Pharmacopoiea general monograph “Tablets”, is 30 minutes rather than the required 15 minutes. | Until further notice |
Wyeth Consumer Healthcare Pty Ltd | Centrum Advance Tablet | 179457 | TGO 78 |
| The estimated content of lutein and lycopene in each tablet is not less than 90.0% and not greater than 165.0% of the stated content. | Until further notice |
Wyeth Consumer Healthcare Pty Ltd | Centrum Advance 50+ Tablet | 179458 | TGO 78 |
| The estimated content of lutein and lycopene in each tablet is not less than 90.0% and not greater than 165.0% of the stated content. | Until further notice |
GlaxoSmithKline | Sensodyne Whitening iso-active Foaming Gel | 172475 | TGO 69 |
| Batches E0N14C1 and E1A06C1are able to be supplied with the identifier “AUST 172475 rather than the correct identifier of “AUST L 172475”. | Until batches E0N14C1 and E1A06C1 are exhausted |
GlaxoSmithKline | Sensodyne Full Protection iso-active Foaming Gel | 174778 | TGO 69 |
| Batches E0N17C1 and E1A04C1are able to be supplied with the identifier “AUST 174778 rather than the correct identifier of “AUST L 174778”. | Until batches E0N17C1 and E1A04C1 are exhausted |