Document ID: chunk:federal_register_of_legislation:F2024C01255:body:0:p6
Version: federal_register_of_legislation:F2024C01255
Segment Type: other
Provision Reference: 
Character Range: 14512–17500

and
           (b) is in the following form: 'BATCH NUMBER',  'BATCH NO.', 'BATCH', 'B', '(B)', 'B/N', 'LOT NUMBER', 'LOT NO.', or 'LOT', or words or symbols to this effect, including a mixture of lower and upper case letters;

       biological medicine means a medicine:

            1.           that is a vaccine; or

            2.           that is a peptide, protein or polysaccharide-based, but is not an antibiotic; and

            3.           that is derived from humans, animals or other organisms or produced through recombinant technology or biotechnology; and

            4.           that is required to be included in the Register as registered goods: and

            5.           is of a kind specified in Part 1 of Schedule 10 to the Regulations,

       but does not include a 'biological' within the meaning of section 32A of the Act;

       calendar pack means a pack containing individual dosage units that is labelled with day/date markings to specify the sequence in which the dosage units in the pack must be used in order to achieve the intended therapeutic activity;

       capacity means the volume of the empty container;

       Certificate of Registration, in relation to a medicine, means the certificate given to the applicant for registration of a medicine under subsection 25AB(4) of the Act in relation to that medicine;

       composite pack has the same meaning as in the Act;

       concentrated solution for injection means a sterile liquid which must be diluted with another sterile liquid in order to prepare an injection;

 container has the same meaning as in the Act;

 default standard has the same meaning as in the Act;

       delivered dose means, in relation to:
           (a) metered dose preparations - the dose delivered to the patient in a single actuation or delivery; and
           (b) powders for inhalation - the dose delivered from the inhaler in a single delivery;

       dial dispenser pack means a container that has the following characteristics:

           (a) each of the dosage units is located in individual pockets preformed in a circular rigid tray;

           (b) a close-fitting, rotatable, transparent lid which can only be rotated in one direction is located over the tray; and

           (c) the individual dosage units can be dispensed by detaching a predefined portion of the lid or tray, and rotating the lid to the appropriate position;

       diluent means a liquid used for reconstitution or dilution;

       distributor means a company or corporate entity, which is not the sponsor, that the sponsor has agreed should be identified on a medicine's label;

       excipient, in relation to a medicine, means an ingredient of the medicine other than the active ingredient and includes adjuvants;

       expiry date, in relation to a product, means the date (month and year) after which the medicine should not be used;

       expiry date prefix means a prefix which precedes the expiry date