Document ID: chunk:federal_register_of_legislation:F2024C01255:body:0:p3
Version: federal_register_of_legislation:F2024C01255
Segment Type: other
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Character Range: 6583–9502

in the design of medicine labels are available on the Therapeutic Goods Administration website (http://www.tga.gov.au).
      2.            Under the Act:

         * whether a medicine conforms to a standard applicable to the medicine is a matter the Secretary must take into account in deciding whether to include the medicine in the part of the Register for registered goods

         * failure to conform to a standard applicable to a medicine is grounds for the Secretary to suspend or cancel the registration of the medicine

         * failure to conform to a standard applicable to a medicine is grounds for the Secretary to require public notification and recovery of the medicine

         * it is an offence to supply medicines in Australia that do not comply with a standard applicable to the medicine relating to labelling or packaging and civil penalties may be payable in relation to such supply

         * whether the presentation of a medicine is acceptable is a matter the Secretary must take into account in deciding whether a medicine can be registered – 'presentation' means the way in which the medicine is presented for supply and includes matters relating to the labelling and packaging of the medicine. Subject to specified notice requirements, the Secretary may decide to suspend or cancel the registration of a medicine, if it appears to the Secretary that the presentation of the medicine is not acceptable

         * the presentation of a supplied medicine which appears to the Secretary to be not acceptable is also grounds for the Secretary to require public notification and recovery of the medicine.

      1.            To avoid doubt, this section is not part of the Order.

       1 Name of Order

       This Order is to be known as the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines.

       3 Application - Therapeutic goods to which this Order applies

       (1) Subject to sections 4 and 5, this Order applies to the following medicines supplied or for supply in Australia:

           (a) Medicines of a kind specified in Part 1 of Schedule 10 to the Regulations, except for the following:

             (i) 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;

             (ii) a medical gas;

             (iii) osmotic pumps;

             (iv) 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;

             (b) composite packs containing a prescription medicine.

       4 Transition arrangements

        1.                     On and  from 31 August 2016 and before 1 September 2020,