Document ID: chunk:federal_register_of_legislation:F2024C01255:body:0:p23
Version: federal_register_of_legislation:F2024C01255
Segment Type: other
Provision Reference: 
Character Range: 59953–62872

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 - a statement to the effect that the medicine when prepared 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;

        1.      Very small containers (not including injections)

           If:

           (a) the medicine is enclosed in a very small container but 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 name of the medicine is displayed in a text size of not less than 1.5 millimetres, together with the following information displayed in a text size of not less than 1.0 millimetre:

           (c) the quantity of the medicine in the container; 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) 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

           (g) if the medicine contains only one active ingredient - the name of the active ingredient and the quantity or proportion of the active ingredient in the medicine, or suitable unambiguous abbreviation of the name and quantity.

        1.      Individually wrapped medicines

           (a) Subject to paragraph (b), if:

              (i) a medicine consists of individual dosage units such as tablets, capsules, pills, pastilles, cachets, lozenges, pessaries, suppositories, single doses of a powder, single doses of a liquid, or a transdermal patch; and

              (ii) each dosage unit is enclosed in an individual wrapper or blister, whether sealed or unsealed; and

              (iii) one or more dosage units are enclosed in a primary pack; and

              (iv) the label on the primary pack complies with sections 8 and 9,

           then, in relation to compliance of the label on each individual wrapper or blister with sections 8 and 9, it shall be sufficient if the following information is displayed:

           (v) the name of the medicine; and

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

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