COMMONWEALTH OF AUSTRALIA
THERAPEUTIC GOODS ACT 1989
SECTIONS 14 and 14A NOTICE
Between 10 November 2009 and 9 April 2010, Delegates 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 |
Bayer Australia Ltd | Elevit with Iodine | 174543 | TGO 56 | 4(2)(a) | The limits of content of the active ingredient calcium, phosphorous, iodine, iron, magnesium and zinc must not be less than 90 per cent and not more than 110 per cent of the stated content. | 31 October 2010 |
Bayer Australia Ltd | Elevit with Iodine | 174543 | TGO 56 | 4(2)(a) | The limits of content of the active ingredients copper and folic acid must not be less than 90 per cent and not more than 125 per cent of the stated content. | 31 October 2010 |
Bayer Australia Ltd | Elevit with Iodine | 174543 | TGO 78 | 11(b) | The limits of content of the active ingredient manganese must not be less than 90 per cent and not more than 134 per cent of the stated content. | Until further notice. |
Bayer Australia Ltd | Elevit with Iodine | 174543 | TGO 56 | 7 | The maximum disintegration time is 60 minutes. | 31 October 2010 |
Bayer Australia Ltd | Elevit with Iodine | 174543 | TGO 78 | 9(1)(b) | The maximum dissolution test time for folic acid is 120 minutes. | Until further notice. |
Bayer Australia Ltd | Elevit with Iodine | 174543 | TGO 78 | 9(1)(b) | The method of testing may be modified to include lauryl sulfate in the dissolution medium, but this must not exceed 0.3%. | Until further notice. |