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:

  1. 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
  2. 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 78

11(b)

The limits of content of the each of the active ingredient must comply with limits stated in Table 1

Goods released for supply prior to 30 April 2014

Bayer Australia Ltd

Elevit with Iodine

174543

TGO 78

11(c)

-

Goods released for supply prior to 30 April 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%