Document ID: chunk:federal_register_of_legislation:F2024C01255:body:0:p17
Version: federal_register_of_legislation:F2024C01255
Segment Type: other
Provision Reference: 
Character Range: 43912–46771

multidose use - the words 'for eye drops'.

        1.          Injections in a container with capacity greater than 100 millilitres

       In addition to the requirements under sections 8 and 9 applying to the label on the container and on the primary pack, a medicine that is an injection in a container having a capacity of greater than 100 millilitres must, except where subsection 10 (7) applies, include the following information or statements on the label on the container and on the primary pack:

           (a) the name and quantity of each excipient in the stated volume of fill of the injection in the container; and

           (b) where the medicine contains an active ingredient that is not intended for electrolyte replacement or nutritional therapy and is not intended for use as a radio-contrast agent or as a plasma volume expander or replacement - the information must include a statement of the proportion of that active ingredient expressed in terms of weight (or potency, if appropriate) in the stated volume of fill of the injection in the container; and

           (c) where the medicine contains more than three active ingredients belonging to the same class of substances, such as amino acids, carbohydrates or electrolytes in the medicine – the information must include the class of substances and the name of the dosage form; and

           (d) where the medicine contains iodine and is intended for use as a radio-contrast agent - a statement of the equivalent amount of iodine in terms of milligrams of iodine per millilitre; and

           (e) where the medicine is intended for use as a radio-contrast agent or as a plasma volume expander or replacement - the product name must include a statement of the proportions of dissolved, emulsified or suspended active ingredient(s) in the goods; and

           (f) the statement 'Use in one patient on one occasion only. Contains no antimicrobial preservative' or words to that effect; and

           (g) where the medicine is intended for electrolyte replacement, has a stated volume of 100 millilitres or less, and is manufactured or imported on or after 1 December 2026 – a statement, located immediately below the text mentioned in subsection 9(3), of:

              (i) for potassium chloride—the equivalent quantity of potassium chloride in weight (in relation to the stated volume of fill of the injection); and

              (ii) for all other active ingredients—the equivalent quantity of each active ingredient in millimoles (in relation to the stated volume of fill of the injection).

        1.          Injections in a container with a capacity of 100 millilitres or less

       Except where subsection 10(4) or 10(5) below applies in relation to the label on a container, if a medicine is an injection in a container with capacity of 100 millilitres or less,