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28 Restricted representations—serious form of disease, condition, ailment or defect

For the purposes of section 42DD of the Act, a form of a disease, condition, ailment or defect is a serious form if: (a) it is medically accepted that the form requires diagnosis or treatment or supervision by a health practitioner who is suitably qualified, except where the form has been medically diagnosed and medically accepted as being suitable for self-treatment and management; or (b) there is a diagnostic (including screening), preventative, monitoring, susceptibility or pre-disposition test available for the form (including a self-administered test), which requires medical interpretation or follow-up; but does not include: (c) pregnancy, other than pregnancy with a medical, obstetric or surgical complication.

Note 1: Sections 42DF and 42DK of the Act provide for the Secretary to approve or permit the use of a restricted representation in certain circumstances.

Note 2: See sections 42DL and 42DLB of the Act for offences and a civil penalty for advertising therapeutic goods, where the advertisement contains a restricted representation.

Note 3: A restricted representation in the form of a warning or contra-indication that is required by a legislative instrument to be included in an advertisement may be used without prior approval (under section 42DF of the Act), permission (under section 42DK of the Act) or authorisation (for the purposes of sections 42DL and 42DLB of the Act).

Note 4: See Part 5-1 of the Act and Part 2 of, and Schedule 2 to, the Regulations for requirements relating to restricted representations and prohibited representations.