Document ID: chunk:federal_register_of_legislation:F2024C01255:body:0:p5
Version: federal_register_of_legislation:F2024C01255
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purposes or formulated as a dosage form; or

           (h) not at its final stage of manufacture; or

           (i) imported for use in the treatment of the importer or the importer's immediate family as set out in Item 1 of Schedule 5 to the Regulations; or

           (j) an export only medicine as defined in the Act; or

           (k) made up or compounded extemporaneously by a pharmacist, or a person in the course of his or her employment by a pharmacist and under the direct personal supervision of that pharmacist, in accordance with the individual prescription of a health professional authorised under a law of a State or Territory to prescribe; or

           (l) made up or compounded extemporaneously, for a specific or individual case, by a pharmacist in the lawful practice of his or her profession; or

           (m) supplied, in the course of treating a patient, by a health professional in the lawful practice of his or her profession, unless it is a medicine described in section 3 of this Order in a starter pack.

       (2) The requirements of this Order do not apply to a transparent covering that encloses or wraps the container or primary pack containing a medicine and where the information that is required to be set out on the label of the container or the primary pack is clearly visible through that transparent covering.

       6 Interpretation

       In this Order:

       Act means the Therapeutic Goods Act 1989;

       active ingredient means a therapeutically active component in a medicine's final formulation that is responsible for its physiological or pharmacological action;

       adjuvant means an ingredient which, when administered with an antigen, modifies the immune response to that antigen;

       antimicrobial preservative means an ingredient added to a medicine to inhibit the growth of micro-organisms in the medicine;

       approved product details, in relation to a medicine, means details in relation to the medicine as approved under section 25 of the Act for the registration of the medicine;

       Australian Approved Names List has the same meaning as in the Regulations;

       batch number means a number, or a combination of numerals, symbols or letters, which is given by a 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;

       biological medicine means