5 Exemptions – Medicines to which this Order does not apply

(1) This Order does not apply to a medicine that is:

(a) intended for use in the treatment of another person in accordance with an approval set out in paragraph 19(1)(a) of the Act; or

(b) intended to be supplied to a Category A person under the exemption provided for in regulation 12A of the Regulations; or

(c) the subject of an authorisation granted under subsection 19(5) of the Act and its use is consistent with the requirements set out in regulation 12B of the Regulations; or

(ca) intended for use in the treatment of humans in accordance with rules specified for the purposes of subsection 19(7A) of the Act; or

(d) exempted from the operation of Division 2 of Part 3-2 of the Act because of an exemption made by the Minister under section 18A of the Act in relation to that medicine; or

(e) the subject of an approval under section 19A of the Act; or

(f) intended for use solely for experimental purposes in humans in accordance with an approval set out in paragraph 19(1)(b) of the Act or in accordance with the requirements set 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.