Document ID: chunk:federal_register_of_legislation:F2023C00456:schedule:3:p9
Version: federal_register_of_legislation:F2023C00456
Segment Type: schedule
Provision Reference: sch 3 (pt 9/27)
Character Range: 24305–27209

capsules or sachets – the stated number of units in the container; or
       (b) where the medicine is:
              (i) a solid or semi-solid - the stated weight in the container;
              (ii) a liquid - the stated volume of fill in the container;
              (iii) a pressurised metered-dose preparation or dry powder inhaler - the stated number of deliverable doses in the container;
              (iv) a non-pressurised metered dose preparation - the minimum number of deliverable doses in the container;
            (c) where the medicine is a medicine of any of the kinds referred to in paragraph (b) and the medicine consists of a number of identical containers within the primary pack – the number of containers (e.g. 5 x 10 mL vials);
           (d) for each of the individual containers within the primary pack, the quantity of the medicine to be included on the individual container label would be as described in paragraph (b) (e.g. the stated volume of fill in the container);

       Register has the same meaning as in the Act;

       registered goods has the same meaning as in the Act;

       registration number means the combination of numbers and letters that is required to be included on the label of medicines in a manner described in regulation 15 of the Regulations;

       Regulations means the Therapeutic Goods Regulations 1990;

       Secretary has the same meaning as in the Act;

       small container means a container that has a capacity less than or equal to 25 millilitres;

       solid ophthalmic medicine means a substance in a container to which a sterile diluent is added to prepare eye drops;

       sponsor has the same meaning as in the Act;

       standard has the same meaning as in the Act;

       standardisation means the process in which the content of a specific chemical constituent(s) has been determined in a herbal material or herbal preparation.

       stated volume of fill means the volume of medicine that the container is specified by the sponsor to contain;

       stated weight means the mass of medicine that the container is specified by the sponsor to contain;
       supply has the same meaning as in the Act;
       text size means the height of upper case (capital) letters or lower case letters having an ascender or descender, unless otherwise stated;

       warning statements means:
           (a)          any labelling requirements specified in the instrument made by the Minister under subsection 3(5A) of the Act, as in force from time to time;
                  Note: These requirements apply to all medicines other than those described in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990

           (b) any warning statements specified in any standard that applies to the medicine;
           (c) any warning statements required by the Secretary to be included on the label as a condition of