Document ID: chunk:federal_register_of_legislation:F2024C01255:body:0:p13
Version: federal_register_of_legislation:F2024C01255
Segment Type: other
Provision Reference: 
Character Range: 33577–36363

an ampoule but is not an injection - 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; and

           (n) a machine readable code, except where the medicine is a starter pack; and

           (o) where the medicine is packaged in a primary pack that is a carton, the name of the medicine on at least three non-opposing sides of the carton.

       (2) The label on a container for a medicine must include a minimum space of 70 x 30 millimetres for the dispensing label, except where:

           (a) the medicine and its container are supplied in a primary pack, in which case the space must be included on the label of the primary pack ; or

           (b) this is precluded by the dimensions of either the container or the primary pack; or

           (c) the medicine is intended only for use in a clinical setting where self-administration will not occur; or

           (d) the medicine is a starter pack.

       (3) If the information required on the label on the container is obscured by intermediate packaging, then the label on the intermediate packaging must include:

           (a) the name of the medicine; and

           (b) the name(s) of all active ingredients in the medicine; and

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

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

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

           (f) the name of the sponsor or distributor, or a registered trademark if it readily identifies the sponsor or distributor of the medicine.

       (4) If the container is enclosed in a delivery device such that it cannot be removed, the information required on its label under subsection 8(1) must be applied on the delivery device and not the container.

       (5) In addition to the requirements under this section, if the medicine comprises both a medicine in a container and an article that is not a device under the provisions of the Act but is included in the primary pack for such purposes as delivery of and/or measuring the medicine, the label on the primary pack must include a description of any such articles.

9 Information to be included on the main label

       (1) Subject to the qualifications and special requirements specified in this section and section 10 of this Order, the information on the main label of the medicine must include:

           (a) the name of the medicine; and

           (b) the name(s) of all active ingredients in the medicine; and

           (c) the quantity or proportion of all active ingredients in the