Document ID: chunk:federal_register_of_legislation:F2024C01255:body:0:p16
Version: federal_register_of_legislation:F2024C01255
Segment Type: other
Provision Reference: 
Character Range: 41364–44165

2.5 millimetres and specified elsewhere in this Order.

       (11) An active ingredient specified in Part 1 of Schedule 2, either alone or in combination with any other descriptors, may be included on the main label of a medicine containing that ingredient as specified in that Part for medicine released for supply before 1 May 2026.

       (12) To avoid doubt, an active ingredient specified in Part 1 of Schedule 2 must be included on the main label of a medicine containing that ingredient in accordance with the Australian Approved Names List for medicine released for supply on or after 1 May 2026.

       (13) An active ingredient specified in Part 2 of Schedule 2, either alone or in combination with any other descriptors, may be included on the main label of a medicine containing that ingredient as specified in that Part for medicine released for supply before 1 May 2028.

       (14) To avoid doubt, an active ingredient specified in Part 2 of Schedule 2 must be included on the main label of a medicine containing that ingredient in accordance with the Australian Approved Names List for medicine released for supply on or after 1 May 2028.

       10 Qualifications and special requirements

        1.          Preparations for ophthalmic use

       In addition to the requirements of sections 8 and 9 above, if a medicine is a preparation for ophthalmic use, the label on the container and on the primary pack or, where subsections 10(11) or 10(12) applies, on the primary pack, must include:

           (a) the name of any antimicrobial preservative in the medicine;

           (b) if the medicine, other than an ophthalmic ointment, does not contain an antimicrobial preservative - the statement 'Contains no antimicrobial preservative. Use once only and discard residue' or words to that effect;

           (c) if the medicine is for multidose use - a statement to the effect that 'the medicine should not be used more than four weeks', or such shorter period as specified in the approved product details in relation to the medicine, after the container is first opened;

           (d) if the medicine 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 more than four weeks or such shorter period as specified in the approved product details in relation to the medicine, after the container is first opened.

           (e) if the medicine consists of a solid ophthalmic medicine for preparing eye drops for 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