Document ID: chunk:federal_register_of_legislation:F2024C01255:body:0:p22
Version: federal_register_of_legislation:F2024C01255
Segment Type: other
Provision Reference: 
Character Range: 57318–60204

to in sections 8 and 9 above, include the name of any antimicrobial preservative in the medicine.

        1.      Starter packs

       Where a medicine is presented in a starter pack, in addition to the requirements referred to in sections 8 and 9, the label on the container or primary pack (if any) must include:

           (a) sufficient space to accommodate a prescriber's addition of at least the following dispensing details: patient's name, prescriber's name and telephone number, directions for use including dose, and date of supply; and
           (b) the statement 'starter pack' or words to that effect.

        1.      Small containers (not including injections)

       If:

           (a) the medicine is enclosed in a small container (but is not a very small container) and is not an injection; and

           (b) the container is enclosed in a primary pack, the label of which complies with sections 8 and 9 and subsection 10(1) (if applicable),

       then, in relation to compliance of the label on the container with sections 8 and 9 and subsection 10(1) (if applicable), it shall be sufficient if the following information is displayed in a text size of not less than 2.0 millimetres:

           (c) the name of the medicine; and

           (d) the name(s) of all active ingredients in the medicine, unless there are four or more active ingredients;

       and the following information is displayed in a text size of not less than 1.5 millimetres:

           (e) where there are four or more active ingredients, the name(s) of all active ingredients in the medicine; and

           (f) the quantity or proportion of all active ingredients in the medicine; and

           (g) the name of the dosage form; and

           (h) the quantity of the medicine in the container; and

           (i) the batch number of the medicine preceded by the batch number prefix; and

           (j) the expiry date of the medicine preceded by the expiry date prefix; and

           (k) the name of the sponsor or distributor as it appears on the primary pack, or registered trademark if it readily identifies the sponsor or distributor of the medicine; and

           (l) if the medicine is contained in an ampoule - a statement of the approved route of administration for the medicine, such as 'inhalation', 'For oral use only' or other phrase, word or abbreviation denoting the approved route(s) of administration of the medicine; and

           (m) if the medicine:

              (i) is an ophthalmic preparation for multidose use - a statement to the effect that the medicine should not be used later than four weeks, or another shorter period as specified in the approved product details in relation to the medicine, after the container is first opened ; or

              (ii) consists of a solid ophthalmic medicine for preparing eye drops for multidose use -