Document ID: chunk:federal_register_of_legislation:F2024C01255:body:0:p30
Version: federal_register_of_legislation:F2024C01255
Segment Type: other
Provision Reference: 
Character Range: 78666–81716

requirements apply in the circumstances specified in the following subparagraphs:

              (i) for preparations containing Vitamin A or a derivative of Vitamin A - as the equivalent quantity or proportion of Vitamin A expressed in terms of microgram retinol equivalents;

              (ii) for a preparation containing biological organisms - as the number of organisms present per metric unit for liquids and powders and as the number of organisms present per dosage unit for other dosage forms;

           (l) for any other medicines:

              (i) where the medicine is a liquid and includes active ingredient which is a liquid- as the appropriate amount of the active ingredient, either by weight or volume, in a stated volume of the medicine;

              (ii) where the medicine is a liquid and includes an active ingredient which is a solid - as the weight of active ingredient in a stated volume of the medicine;

              (iii) where the medicine is a liquid and includes an includes an active ingredient which is a gas  - as the weight of the active ingredient in a stated volume of the medicine;

              (iv) where the medicine is a solid or semi-solid and includes an active ingredient which is a liquid - as the appropriate amount of the active ingredient, either by weight or volume, in a stated weight of the medicine;

              (v) where the medicine is a solid or semi-solid and includes an active ingredient which is a solid - as the weight of the active ingredient in a stated weight of the medicine.

        1.          Expression of potency in biological medicines

           (a) For a liquid biological medicine or a biological medicine required to be prepared before use, the potency:

              (i) must be included on the label of the medicine; and

              (ii) must be expressed as potency units, or weight of active ingredient per dose or per unit volume, or as the volume which contains the recommended dose.
            1.           The potency unit to be used must be:
               1.             the International Unit (IU) established by the World Health Organization;
               2.          a unit defined in an applicable default standard; or
               3.        where IU or pharmacopoeial monographs have not been established, then the potency unit to be used is that specified in the approved product details in relation to the medicine.

        1.          Expression of activity of radionuclides in radiopharmaceutical preparations

       The quantity or proportion of an active ingredient which is a radionuclide and is included in a radiopharmaceutical preparation must be:
            1.            included on labels; and

            2.            expressed in 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