Examples of applying the definition of ‘serious’ Condition s. 28(1)(a) - medically accepted that the form requires diagnosis or treatment or supervision by a suitably qualified health professional s. 28(1)(a) – exclusion for forms that have been medically diagnosed and medically accepted as being suitable for self-treatment and management s. 28(1)(b) - there is a diagnostic (including screening), preventative, monitoring, susceptibility or pre-disposition test available for the form (including a test), which requires medical interpretation or follow-up Restricted representation status Arthritis Arthritis is an umbrella term that can a wide variety of forms and severities, like debilitating osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis. These are forms that require medical diagnosis. Management is variable but likely to involve prescription medicines. The appropriate treatment must be determined by a health professional. Arthritis meets the definition of ‘serious’. As such, representations in advertising that include unqualified references to arthritis are restricted representations. Mild arthritis The more serious forms of arthritis detailed above are excluded by the qualifier ‘mild’. Not applicable ‘Mild arthritis’ does not meet the definition of ‘serious’. As such, representations in advertising that include references to ‘mild arthritis’ are not restricted representations, as long as the mild nature is not contradicted by images, testimonials or any self-
other aspect of the advertising. Autism spectrum disorder (ASD) Clinically accepted that an experienced paediatrician or a child psychiatrist should confirm the diagnosis Management may involve prescription psychotropic medicines (if warranted). Allied health professionals may also be needed. Not applicable ASD meets the definition of ‘serious’. Therefore, representations in advertising that include references to ASD are restricted representations. Cystic fibrosis (CF) Management of CF includes antibiotic therapy and prescription medicines and treatment by physiotherapist. In Australia, CF is usually detected through a newborn screening test and/or a test. The results require medical interpretation and follow-up. 1 CF meets the definition of ‘serious’. As such, representations in advertising that include references to CF are restricted representations.
(c) is on any material included with the package in which the goods are contained Approval number the distinguishing number allocated to an approved advertisement by the Secretary under regulation 5J of the Therapeutic Goods Regulations Section 42B of the Act Approval number a distinguishing number given to each approved advertisement Regulation 5J, Therapeutic Regulations 1990 Approved advertisement an advertisement: (a) approved under regulation 5G, or taken to be approved by the Secretary under subregulation 5H(2), or approved by the Minister on review under regulation 5M, of the Therapeutic Goods Regulations; and (b) the approval of which has not been withdrawn Section 42B of the Act Bench-mark price brand in relation to a multi branded medicine, means the lowest priced product within the group of medicines that are listed on the Pharmaceutical Benefits Scheme as brands of the same medicine Therapeutic Goods Advertising Code 2018 Broadcaster in relation to an advertisement for therapeutic goods, means a person (other than a person who is required to enter those goods on the Register) who undertakes, as a business activity in its own right: (a) the broadcasting of the advertisement in broadcast media; or (b) the placement of the advertisement for such broadcasting Section 42B of the Act Broadcast media in relation to an advertisement or generic information, means any means (other than a means declared in the regulations to be an exempted means) by which the information is disseminated electronically in a visible or audible form or a combination of such forms Section 42B of the Act Child means an individual under the age of 18 Therapeutic Goods Advertising Code Complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use Regulation 2 in the Regulations Directions for use in relation to therapeutic includes information on: (a) appropriate doses of the goods; and (b) the method of administration or use of the goods; and Subsection 3(1) of the Act
Regulations the Therapeutic Goods Regulations 1990 Therapeutic Goods Advertising Code Required representation a representation referred to in subsection 42DJ(2) Section 42B of the Act Restricted representation a representation referred to in section 42DD Section 42B of the Act Specified media in relation to an advertisement or generic information, means: (a) mainstream media; or (b) broadcast media; or (c) cinematograph films; or (d) displays about goods, including posters: (i) in shopping malls (except inside an individual shop); and (ii) in or on public transport; and on billboards Section 42B of the Act Sponsor in relation to therapeutic goods, means: (a) a person who exports, or arranges the exportation of, the goods from Australia; or (b) a person who imports, or arranges the importation of, the into Australia; or (c) a person who, in Australia, manufactures the or arranges for another person to manufacture the goods, for supply (whether in Australia or elsewhere); but does not include a person who: (d) exports, imports or manufactures the goods; or (e) arranges the exportation, importation or manufacture of the on behalf of another person who, at the time of the exportation, importation, manufacture or arrangements, is a resident of, or is carrying on business in, Australia Subsection 3(1) of the Act State includes the Australian Capital Territory and the Northern Territory Subsection 3(1) of the Act law a law of a State, of the Australian Capital Territory or of the Northern Territory Subsection 3(1) of the Act Supply includes: (a) supply by way of sale, exchange, gift, lease, loan, hire or hirepurchase; and Subsection 3(1) of the Act