Subsection Medicine means: 3(1) of the (a) therapeutic goods (other than biologicals) that are Act represented to achieve, or are likely to achieve, their principal intended action by pharmacological, chemical, immunological or metabolic means in or on the body of a human; and (b) any therapeutic goods declared by the Secretary, for the purpose of the definition of therapeutic device, not to be therapeutic devices Therapeutic Other therapeutic that are not medicines, biologicals or medical Goods therapeutic devices Advertising goods Code Clause 13A.3 Patient In relation to an implantable device, means: of Schedule 1 information (1) A leaflet (a patient information leaflet) that meets the to the leaflets requirements of subclauses (2) to (4) and clause 13A.4 Medical must be provided with the medical device Devices Regulations (2) The leaflet must include the following information: 2002 (as they will be (a) information identifying the device, or the kind of amended in device December (b) the intended purpose of the device 2018) (c) information explaining how to use the device safely (d) information about the device as specified in Clause 13A.3 that the manufacturer considers would be useful for patients (3) In particular, the leaflet must include the information specified in subclause (3) Therapeutic Poisons means the Standard in force under section 52D of the Act at Goods Standard the commencement of this Code Advertising Code Subsection Presentation in relation to therapeutic goods, means the way in which the 3(1) of the goods are presented for supply, and includes matters relating Act to the name of the goods, the labelling and packaging of the goods and any advertising or other informational material associated with the goods Therapeutic information about: Goods information (a) the purchase price of medicines that is to be paid by Advertising consumers of those medicines; and Code (b) in relation to medicines that are listed on the Pharmaceutical Benefits Scheme (or Repatriation
Medicine means: (a) therapeutic goods (other than biologicals) that are represented to achieve, or are likely to achieve, their principal intended action by pharmacological, chemical, immunological or metabolic means in or on the body of a human; and (b) any therapeutic goods declared by the Secretary, for the purpose of the definition of therapeutic device, not to be therapeutic devices Subsection 3(1) of the Act Other therapeutic goods therapeutic that are not medicines, biologicals or medical devices Therapeutic Goods Advertising Code Patient information leaflets In relation to an implantable device, means: (1) A leaflet (a patient information leaflet) that meets the requirements of subclauses (2) to (4) and clause 13A.4 must be provided with the medical device (2) The leaflet must include the following information: (a) information identifying the device, or the kind of device (b) the intended purpose of the device (c) information explaining how to use the device safely (d) information about the device as specified in Clause 13A.3 that the manufacturer considers would be useful for patients (3) In particular, the leaflet must include the information specified in subclause (3) Clause 13A.3 of Schedule 1 to the Medical Devices Regulations 2002 (as they will be amended in December 2018) Poisons Standard means the Standard in force under section 52D of the Act at the commencement of this Code Therapeutic Goods Advertising Code Presentation in relation to therapeutic goods, means the way in which the goods are presented for supply, and includes matters relating to the name of the goods, the labelling and packaging of the goods and any advertising or other informational material associated with the goods Subsection 3(1) of the Act information information about: (a) the purchase price of medicines that is to be paid by consumers of those medicines; and (b) in relation to medicines that are listed on the Pharmaceutical Benefits Scheme (or Repatriation Therapeutic Goods Advertising Code