COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
SECTIONS 14 and 14A NOTICE
On 14 April 2014, the Delegate of the Secretary of the Department of Health gave consent, pursuant to sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act), to the following:
- The supply and 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 |
Bayer Australia Ltd | Elevit with Iodine Batch number 81647306 (100 tablet pack) and 81647276 (30 tablet pack) | 174543 | TGO 78 | 11(b) | The limits of content of the each of the active ingredient must comply with limits stated in Table 1
| The consent for importation and supply expires on 31 July 2014 |
Bayer Australia Ltd | Elevit with Iodine Batch number 81647306 (100 tablet pack) and 81647276 (30 tablet pack) | 174543 | TGO 78 | 11(c) | - | The consent for importation and supply expires on 31 July 2014 |
Table 1
Calcium | 90 – 110% |
Phosphorus | 90 – 110% |
Iodine | 90 – 110% |
Copper | 90 – 125% |
Iron | 90 – 110% |
Magnesium | 90 – 110% |
Zinc | 90 – 110% |
Folic acid | 90 – 125% |
Ascorbic acid | 90 – 121% |
Nicotinamide | 90 – 115.5% |
dl-alpha tocopheryl acetate | 90 – 121% |
Cholecalciferol | 90 – 132% |
Pyridoxine hydrochloride | 90 – 121.2% |
Calcium pantothenate | 90 – 115.5% |
Riboflavine | 90 – 121.1% |
Thiamine nitrate | 87.5 – 117.5% |
Cyanocobalamin | 85 – 138% |
Biotin | 85 – 126.5% |