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

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

(1) Subject to subsection (2), 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 suitably qualified health professional, 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.

(2) A serious form of a disease, condition, ailment or defect does not include: (a) pregnancy, other than pregnancy with a medical, obstetric or surgical complication; or (b) any of the diseases mentioned in section 30.

Note 1: Section 42DD of the Act provides that a representation that refers to a serious form of a disease, condition, ailment or defect is a restricted representation.

Note 2: 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 3: 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.