Document ID: chunk:federal_register_of_legislation:F2023C00456:schedule:3:p4
Version: federal_register_of_legislation:F2023C00456
Segment Type: schedule
Provision Reference: sch 3 (pt 4/27)
Character Range: 10891–13764

out in Item 3 of Schedule 5A to the Regulations; or

           (g) a starting material used in the manufacture of a medicine, except when pre-packaged for supply for other therapeutic 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, for a specific or individual case, by a pharmacist in the lawful practice of his or her profession; or

           (l) supplied, in the course of treating a patient, by a health professional in the lawful practice of his or her profession; or

           (m) made up or compounded extemporaneously, for a specific and individual case, by a complementary healthcare practitioner in the lawful practice of his or her profession; or

           (n) goods that contain a substance mentioned in Schedule 9 to the Poisons Standard or a substance that is not mentioned in Schedule 9 but which meets the criteria for mention in that Schedule when making a decision to amend the Poisons Standard under section 52D(2) of the Act; or

           (o) a medical gas; or

           (p) osmotic pumps; or

           (q) blood products under Item 13 that are described under paragraphs (a) and (b) under the heading 'HUMAN BLOOD PRODUCTS' in Appendix A to the Poisons Standard.

       (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;

       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