Document ID: chunk:federal_register_of_legislation:F2024C01255:body:0:p4
Version: federal_register_of_legislation:F2024C01255
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Character Range: 9200–12108

under paragraphs (a) and (b) under the heading 'HUMAN BLOOD PRODUCTS' in Appendix A to the Poisons Standard;

             (b) composite packs containing a prescription medicine.

       4 Transition arrangements

        1.                     On and  from 31 August 2016 and before 1 September 2020, each medicine to which this Order applies must comply with either:

            1.            the requirements  specified in this Order; or

            2.            the requirements specified in:

              1.        Therapeutic Goods Order No. 69 General requirements for labels for medicines (TGO 69), up until 30 June 2017 (inclusive); or

              2.      Therapeutic Goods Order No. 69 - General Requirements for Labels for Medicines 2017 (TGO 69 (2017)), on or after 1 July 2017.

        1.                     On and from 1 September 2020, each medicine to which this Order applies must comply with the requirements specified in this Order.

        1.                     Notwithstanding subsections (1) and (2), medicines imported into or manufactured in Australia before 1 September 2020 but supplied by a person other than the sponsor after that date must comply with TGO 69 (2017) if at the time of their release for supply they complied with TGO 69 (2017).

       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