Section 14 and 14a Notice
R12/ 1048892
Between 18th September 2012 and 24th December 2012, 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 | Column 3 | Column 4 | Column5 | Column 6 | Column 7 |
Sponsor | Goods or Classes of Goods | ARTG No. | Standard | Clause | Conditions | Period for which consent is given |
Pfizer Australia Pty Ltd | Centrum for Men | 200421 | TGO 78 | 10(b) | The upper limit for the contents of lutein and lycopene in the tablets can increase from 120% to 165.0% of the stated content. | Until further notice |
Centrum for Women | 200414 | |||||
Health World Limited | Metagenics Estrofactors | 197988 | TGO 78 | 10(b) | The upper limit of 150% for calcium folinate as specified in TGO 78 can be exceeded in one packaged batch made from bulk batch 15291 | Applicable to Batch 15291 only. |
Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi-Aventis Consumer Healthcare | Cenovis Men’s Multi Performance | 202158 | TGO 69 | 3(2)(g) | Product label does not include the Required Advisory Statements for Medicine Labels (RASML) statements 32 and 33:
Label that includes the following abridged version of RASML statement 31:
| Until further notice. |
Pharmacare Laboratories Pty Ltd | Nature’s Way High Strength Olive Leaf 6000mg | 192703 | TGO 78 |
| The upper limit of 120% for oleuropein can be waived. | Applicable to packaged batch made from bulk batch 15659 of capsules. |
Nestle Australia Ltd | Anticol Extra Strong | 203083 | TGO 69 | 3(12)(a) | The individual unsealed wrapper around each lozenge is not required to include the product name, the names of all the active ingredients and their quantities, provided the individual wrappers include the name of sponsor, and the outer label of the pack complies fully with TGO 69 | Until further notice |
Bausch & Lomb Australia Pty Ltd | Ocuvite Lutein capsules | 200282 | TGO 78 |
| Adopt limits of 90.0 – 150.0% for the content of lutein in each capsule. | Until further notice. |