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Limitations apply to the use of certain representations in the advertising of therapeutic goods.
These include serious forms of a disease, condition, ailment or defect and some particular conditions like cancer, sexually transmitted diseases and mental illness.
Using references to these representations in your advertising requires TGA approval.
Restricted representations
'Restricted representations are representations which refer to a serious form of a disease, condition, ailment or defect.
Restricted representations cannot be used in advertising without prior approval or permission from the TGA with the exception of restricted representations that are legally required to be included on the product label.
Serious forms are those which require a suitably qualified health professional to diagnose and/or treat them. The TGA excludes those conditions that are suitable for self-treatment once medically diagnosed.
Approval to use a 'restricted representation' can be given to individual applicants or, in particular circumstances, to all advertisers. More information is presented at the webpage titled restricted representations.
For details refer to Part 8, Section 28 of the Code, which also references related sections in the Act.
Applying to use a restricted representation
If you intend to use a restricted representation in advertising and the representation is not covered by an existing permission, advertisers need to make an application to the TGA.
Prior to commencing an application, advertisers should familiarise themselves with the related guidance and checklist.
To complete an application to use a restricted representation in advertising:
Prohibited representations
'Prohibited representations' in advertising must not be used unless such use has been expressly permitted by the TGA.
A prohibited representation is a representation regarding the treatment, cure, prevention, diagnosis (including screening) or monitoring of, or the susceptibility or pre disposition to, one or more of the following:
- neoplastic diseases (i.e. all types of cancer)
- sexually transmitted diseases
- human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS)
- hepatitis C virus (HCV)
- mental illness.
Representations regarding abortifacient action are also prohibited representations.
Other prohibited representations apply to particular types of therapeutic goods, including analgesics, disinfectants and antiseptics, and vitamins and minerals. All prohibited representations are set out in Part 1 of Schedule 2 of the Regulations.
The TGA may permit advertisers to use prohibited representations if the use is is necessary for public health reasons or for the appropriate use of the good.
The TGA publishes approval and permissions for both 'restricted' and 'prohibited' representations on its website at Notices of approved and permitted restricted representations.