COMMONWEALTH OF AUSTRALIA
Department of Health and Ageing
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
SECTIONS 14 and 14A NOTICE
On 20 August 2013, 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 and exportation 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 | 213113 | TGO 78 | 11(a) | The goods are not required to comply with TGO 78 section 11(a) but must comply with the requirements of the British Pharmacopoeia Appendix XII C Uniformity of Weight (Mass).
| Until further notice. |
Bayer Australia Ltd | Elevit | 213113 | TGO 78 | 11(b) | The goods are not required to comply with TGO 78 section 11(b) but the average content of each active ingredient in the goods must comply with the relevant acceptance criteria included in Table 1. | Until further notice. |
Bayer Australia Ltd | Elevit | 213113 | TGO 78 | 11(c) | The goods are not required to comply with TGO 78 section 11(c) but must comply with the dissolution requirements of the United States Pharmacopeia-National Formulary, Dietary Supplement Chapter <2040> ‘Disintegration and Dissolution of Dietary Supplements’ for riboflavine (Vitamin B2) and iron. | Until further notice. |
Table 1: Acceptance criteria for Assay of Active ingredients
Active ingredient | Label Claim (LC) | Units for LC | Acceptance criteria in units of label claim | Acceptance criteria in units of percentage of label claim | ||
Thiamine (Vitamin B1, as thiamine nitrate) | 1.4 | mg | 1.26 | 1.69 | 90.0 | 120.7 |
Riboflavine (Vitamin B2) | 1.4 | mg | 1.26 | 1.69 | 90.0 | 120.7 |
Nicotinamide | 18 | mg | 16.2 | 20.8 | 90.0 | 115.6 |
Pantothenic acid (Vitamin B5, as calcium pantothenate) | 6 | mg | 5.4 | 7.3 | 90.0 | 121.7 |
Pyridoxine (Vitamin B6, as pyridoxine hydrochloride) | 1.9 | mg | 1.71 | 2.30 | 90.0 | 121.1 |
Cyanocobalamin (Vitamin B12) | 2.6 | µg | 2.34 | 3.70 | 90.0 | 142.3 |
Ascorbic Acid (Vitamin C) | 85 | mg | 76.5 | 102.9 | 90.0 | 121.1 |
Cholecalciferol (Vitamin D3 200 IU) | 5 | µg | 4.5 | 7.4 | 90.0 | 148.0 |
dl-alpha tocopherol (Vitamin E, as dl-alpha tocopheryl acetate) | 18.7 | mg | 16.83 | 24.68 | 90.0 | 132.0 |
Biotin (Vitamin H) | 30 | µg | 27.0 | 38.0 | 90.0 | 126.7 |
Folic acid | 800 | µg | 720.0 | 1056.0 | 90.0 | 132.0 |
Calcium (as calcium hydrogen phosphate anhydrous, calcium pantothenate and calcium carbonate) | 125 | mg | 113.0 | 138.0 | 90.4 | 110.4 |
Copper (as cupric sulfate anhydrous) | 1 | mg | 0.9 | 1.1 | 90.0 | 110.0 |
Iodine (as potassium iodide) | 220 | µg | 198.0 | 253.0 | 90.0 | 115.0 |
Iron (as ferrous fumarate) | 60 | mg | 54.0 | 66.0 | 90.0 | 110.0 |
Magnesium (as magnesium oxide – heavy and magnesium stearate) | 100 | mg | 90.0 | 110.0 | 90.0 | 110.0 |
Manganese (as manganese sulfate monohydrate) | 1.9 | mg | 1.71 | 2.38 | 90.0 | 125.3 |
Selenium (as sodium selenite) | 50 | µg | 45.0 | 55.0 | 90.0 | 110.0 |
Zinc (as zinc citrate trihydrate) | 11 | mg | 9.9 | 12.1 | 90.0 | 110.0 |