Document ID: chunk:federal_register_of_legislation:F2023C00456:schedule:3:p5
Version: federal_register_of_legislation:F2023C00456
Segment Type: schedule
Provision Reference: sch 3 (pt 5/27)
Character Range: 13513–16478

manufacturer to a batch of medicine, to uniquely identify that batch and from which it is possible to trace that batch through all stages of manufacture and distribution;

       batch number prefix means the prefix which precedes the batch number and has the following characteristics:
           (a) clearly indicates that the information following the prefix is the batch number; 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;

       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 Listing, in relation to a medicine, means the certificate given to the applicant for listing of the medicine under subsection 26(4) or subsection 26A(9) of the Act in relation to that medicine;

       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;

       complementary healthcare practitioner means a person described in paragraph 42AA(1)(c) of the Act;

       composite pack has the same meaning as in the Act;

       container has the same meaning as in the Act;

       critical health information means information required under paragraphs 8(1)(b), (c), (j), (k), (l) and (n) of this Order, that is critical for safe use of medicines that are self-selected by a consumer;

       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;

       directions for use has the same meaning as in the Act;

       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;

       expiry date, in relation to a product,