Document ID: chunk:federal_register_of_legislation:F2024C01255:body:0:p31
Version: federal_register_of_legislation:F2024C01255
Segment Type: other
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Character Range: 81427–83122

terms of the total activity of the radionuclide in the container, in becquerels, at a specified date and hour.

        1.          Permitted statements of storage temperature conditions

       For the purposes of this Order, the following statements of storage temperature conditions are permitted:

           (i) 'Store below –18oC (Deep freeze)';

           (ii) 'Store below –5oC (Freeze)';

           (iii) 'Store at 2oC to 8oC (Refrigerate. Do not freeze)';

           (iv) 'Store below 25oC';

           (v) 'Store below 30oC'; and

           (vi) any other storage temperature conditions as specified in the approved product details in relation to the medicine.

        1.          Inclusion of common names of vitamins

       Where a medicine contains an active ingredient that is a vitamin, then the word 'vitamin', or any suitable unambiguous abbreviation of the word vitamin, together with the common name of that vitamin, may appear on a main label of the medicine either:

            1.            on the same line of text - between the approved name of the active ingredient that is a vitamin and the quantity of that active ingredient; or

            2.             on a separate line of text - immediately below the related name of the active ingredient that is a vitamin and the quantity of that active ingredient.

       12 Application, savings and transitional provisions

       Section 11, as in force immediately before the amendments made by the Therapeutic Goods (Therapeutic Goods Order No. 91– Standard for labels of prescription and related medicines) Amendment Order 2024, continues to apply to medicines manufactured or imported before 1 December 2026.