Sch 13Consumer medicine information documents

Schedule 13—Consumer medicine information documents Note: See subregulation 9A(1A). ## 1 General requirements #### 1 General requirements A consumer medicine information document about a medicine must: (a) be written in English; and (b) be clearly legible; and (c) be written in language that will easily be understood by patients; and (d) be consistent with product information about the product. ## 2 Specific requirements—document enclosed within packaging etc. #### 2 Specific requirements—document enclosed within packaging etc. Also, if the consumer medicine information document about a medicine is enclosed within, on a surface of, or affixed to a surface of, the packaging of the medicine, it must set out all of the information required by the “TGA Consumer Medicine Information (Non‑prescription Medicine) Template” (published by the Therapeutic Goods Administration on its website) but: (a) it is not required to set out the information in the same order as the Template; and (b) it is not required to include any Consumer Medicine Information (CMI) summary that forms part of that Template. ## 3 Specific requirements—document not enclosed within packaging etc. #### 3 Specific requirements—document not enclosed within packaging etc. Also, if the consumer medicine information document about a medicine is not enclosed within, on a surface of, or affixed to a surface of, the packaging of the medicine: (a) it must set out all of the information required by the “TGA Consumer Medicine Information (Non‑prescription Medicine) Template” (published by the Therapeutic Goods Administration on its website) in the same order as the Template; and (b) if it is supplied in electronic form, it must be in the form of a PDF file or an HTML file. ## 1A Class 1 biologicals #### 1A Class 1 biologicals For the purposes of the definition of Class 1 biological in regulation 2, a biological is a Class 1 biological if: (a) it is a faecal microbiota transplant product; and (b) it is not advertised to consumers; and (c) it is to be collected under the supervision or direction, or in accordance with the requirements, of a medical practitioner registered, in a State or internal Territory, as a medical practitioner; and (d) each later step in the manufacture of it is to be carried out in a hospital by, or under the supervision or direction of, the practitioner (unless the step relates to the storage or testing of the biological, in which case it may instead be carried out by a person under a contract with the hospital in a State or internal Territory); and (e) it is for use in a recipient who is a patient of the hospital with the recipient being under the clinical care of the practitioner. ## 1 Class 4 biologicals #### 1 Class 4 biologicals For the purposes of the definition of Class 4 biological in regulation 2, the following biologicals are Class 4 biologicals: (a) biologicals that comprise or contain: (i) live animal cells; or (ii) live animal tissues; or (iii) live animal organs; (b) biologicals to which both of the following paragraphs apply: (i) the biologicals comprise, contain or are derived from human cells or human tissues that have been modified to artificially introduce a function or functions of the cells or tissues; (ii) the artificially introduced function or functions were not intrinsic to the cells or tissues when they were collected from the donor; (c) pluripotent stem cells; (d) biologicals derived from pluripotent stem cells.