Document ID: chunk:federal_register_of_legislation:F2023C00456:schedule:3:p3
Version: federal_register_of_legislation:F2023C00456
Segment Type: schedule
Provision Reference: sch 3 (pt 3/27)
Character Range: 8318–11139

for labels of prescription and related medicines.

       (2) To avoid doubt, this Order will apply to the following medicines:

          (a) medicines of a kind specified in Parts 2 and 3 of Schedule 10 to the Regulations and

          (b) medicines exempt from the listing and registration requirements, other than those specified in section 5 of this Order.

       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:

           (a) the requirements specified in this Order; or

           (b) the requirements specified in:

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

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

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

       (3) Notwithstanding (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