Document ID: chunk:federal_register_of_legislation:F2024C01255:body:0:p10
Version: federal_register_of_legislation:F2024C01255
Segment Type: other
Provision Reference: 
Character Range: 25533–28412

number of deliverable doses in the container;
              (iv) a non-pressurised metered dose preparation - the minimum number of deliverable doses in the container;
              (v) a solid biological medicine - the stated weight, number of doses or potency units in the container;
              (vi) a liquid biological medicine - the stated volume of fill in the container and
              (A) the stated weight, total number of doses or potency units in the container, or
              (B) the stated weight, number of doses or potency units per unit volume, and
           (c) subject to paragraph (d), 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. for a liquid that is not a biological medicine, 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 having a capacity less than or equal to 25 millilitres that is not a very small container;

       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;

       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;

       starter pack means:
            1.           for medicines for which a pharmaceutical benefit is payable - a pack that does not exceed one-third of the most commonly prescribed pharmaceutical benefits quantity (the pharmaceutical benefits primary quantity); and
            2.           for other medicines - a pack that does not exceed one-third of the smallest trade pack; and
            3.           where it is not practical to produce a pack for a medicine that is one-third of the most commonly prescribed pharmaceutical benefits quantity or of the smallest trade pack, whichever is relevant, the smallest trade pack for the medicine;
       supply has the same meaning as in the Act;
       text size means the height of upper