Document ID: chunk:federal_register_of_legislation:F2023C00019:clause:1_4:p3
Version: federal_register_of_legislation:F2023C00019
Segment Type: clause
Provision Reference: sch 1 cl 4 (pt 3/4)
Character Range: 12706–15600

provided with the device; or
(b) the instructions for use of the device; or
(c) any advertising material applying to the device; or
(d) any technical documentation describing the mechanism of action of the device.
Medical Devices Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002.
other therapeutic goods means therapeutic goods that are not medicines, biologicals or medical devices.
patient information leaflet has the same meaning as in the Medical Devices Regulations.
pharmaceutical benefits scheme has the meaning given by section 99ZH of the National Health Act 1953.
pharmacy marketing group means an organisation that provides marketing or promotional services to community pharmacies that operate under the same pharmacy brand or banner.
price information, in relation to medicines that are registered goods and contain a substance included in Schedule 3, 4 or 8 to the current Poisons Standard (but not a substance that is included in Appendix H of the current Poisons Standard), means information about:
 (a) the total purchase price of medicines that is to be paid by consumers of those medicines; or
 (b) for medicines that are listed on the pharmaceutical benefits scheme or Repatriation Pharmaceutical Benefits Scheme—the price paid by the consumer when the prescription is dispensed.
price information list has the meaning given by subsection 33(1).
prominently displayed or communicated, in relation to a statement in an advertisement, means:
 (a) either:
 (i) for a visual statement—easily read from a reasonable viewing distance for the particular media type in the context in which the advertisement is intended to be viewed; or
 (ii) for a spoken statement—able to be clearly heard and understood; and
 (b) repeated as often as is necessary to be noticed by a viewer or listener.
public health campaign means a campaign about a public health matter that is conducted, approved or funded by one or more of the following:
 (a) the Commonwealth;
 (b) a state or territory;
 (c) a Commonwealth, state or territory statutory authority.
Regulations means the Therapeutic Goods Regulations 1990.
Repatriation Pharmaceutical Benefits Scheme has the same meaning as in the Veterans' Entitlements Act 1986.
serious, in relation to a form of a disease, condition, ailment or defect, has the meaning given by section 28.
short form advertisement means:
 (a) in relation to a radio advertisement—an advertisement that is 15 seconds or less in duration;
 (b) in relation to a text only advertisement—an advertisement that consists of 300 characters or less for which there is no reasonable capacity to include a picture, logo or other imagery as part of the advertisement;
       but does not include an advertisement that is published on social media.
TGO 91 means the Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines.