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Restricted and prohibited representations
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
Referring to serious forms of a disease, condition, ailment or defect in advertising therapeutic goods is restricted. These references are known as restricted representations.
Serious forms are those which require a suitably qualified health professional to diagnose and/or treat them and exclude those conditions that are suitable for self-treatment once medically diagnosed.
In particular circumstances, the TGA may allow advertisers to refer to these serious forms if it's considered to be in the public interest. Unless granted to a specific person or business, these permissions apply to all advertisers promoting the specified goods.
All current permissions are detailed as notices of approved and restricted representations.
Find out more about restricted representations.
For details refer to Section 28 of the Code, which also references related sections in the Act.
Requesting to use a restricted representation
If you're intending to refer to a restricted representation in your advertising and no permission exists or your claims or goods are not captured by the terms of an existing permission, you'll need to make an application to TGA. This includes representations made on the product's labels, packaging and accompanying information.
Prior to commencing an application, advertisers should familiarise themselves with the related guidance and checklist.
Complete an application for approval to use a restricted representation in advertising.
Prohibited representations
Referring to diseases including neoplastic diseases (i.e. all types of cancer), sexually transmitted diseases, HIV/AIDS, Hepatitis C virus, mental illness or an abortifacient action in advertising therapeutic goods is prohibited. These references are known as prohibited representations.
Other prohibited representations apply to particular types of therapeutic goods, including analgesics, disinfectants and antiseptics, plus vitamins and minerals.
In particular circumstances, the TGA may allow advertisers to use prohibited representations if it's considered to be in the public interest or necessary for product usage.
All current permissions are detailed as notices of approved and restricted representations.
For details refer to Schedule 2 of the Regulations and Section 30 of the Code, which also references related sections in the Act.