Document ID: chunk:federal_register_of_legislation:F2023C00456:schedule:3:p2
Version: federal_register_of_legislation:F2023C00456
Segment Type: schedule
Provision Reference: sch 3 (pt 2/27)
Character Range: 5742–8580

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

          * an applicant for the listing of a medicine must certify that the medicine conforms to every standard applicable to the medicine

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

          * an applicant for the listing of a medicine must certify that the presentation of the medicine is not unacceptable. Unacceptable presentation is a ground for suspension or cancellation of the listing of a medicine

          * there are also grounds for the Secretary to require public notification and recovery of supplied medicines if:

                   + in the  case of registered medicines, it appears to the Secretary that the presentation of the medicine is not acceptable; and
                   + in the case of listed medicines, it appears to the Secretary that the presentation of the medicine is unacceptable.

    (8) 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. 92 - Standard for labels of non-prescription medicines.

       3 Application - Therapeutic goods to which this Order applies

       (1) Subject to sections 4 and 5, this Order applies to medicines supplied or for supply in Australia, other than those specified under section 3 of the Therapeutic Goods Order No. 91 – Standard 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