In advertisements for therapeutic goods, the use of representations that refer to diseases or conditions which are serious and require involvement with a health professional for appropriate management are either restricted or prohibited.
‘Restricted representations’ must only be used with our prior approval and ‘prohibited representations’ are permitted only in circumstances where their use is necessary for the appropriate use of the advertised good or necessary in the interests of public health. For both restricted and prohibited representations approval or permission must be in place before they can be used in advertisements.
Our prior scrutiny of these types of representations is to ensure the vulnerability of consumers who have a serious disease or condition is not taken advantage of by advertising claims and to ensure consumers are not inappropriately influenced to try and self-manage their serious disease or condition.
Significant fines and penalties apply if you use restricted or prohibited representations in an advertisement without prior approval or permission from us.
The Act, Regulations and Code are the legal source of this information:
- Therapeutic Goods Act 1989
- Therapeutic Goods Regulations 1990
- Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021.
The Guidance explains requirements under the Code:
Restricted representations
Restricted representations are references to a serious form of:
- disease
- condition
- ailment
- defect.
Pregnancy, other than pregnancy with a medical, obstetric, or surgical complication is not a restricted representation.
Definition of serious forms
The definition of a ‘serious form’ of a condition, ailment, disease or defect are those which require a health professional to diagnose, follow-up or treat.
Our guidance on Part 8 of the Advertising Code provides more detailed information on what constitutes a serious form of a condition, ailment, disease or defect - see Applying the Advertising Code rules: restricted representations.
When you may use a restricted representation
You cannot use restricted representations in any form of advertising unless:
- you have our prior approval or permission
- the restricted representation is a part of a ‘health warning’ that is required in certain advertisements
Our approval can be given to applicants to use a restricted representation.
At times, we may broadly grant permission to all advertisers to use a restricted representation. You cannot apply for a permission.
Applying to use a restricted representation
If you want to use a restricted representation in your advertising, you need to seek approval from us first.
You submit an application through the Regulatory and Compliance portal:
Help can be found:
Prohibited representations
While you cannot apply to the TGA to use prohibited representations in advertising, we can permit their use in specific advertisements if necessary for public health or for the appropriate use of the goods.
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 (for example, 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.
Some prohibited representations apply to particular types of therapeutic goods such as:
- analgesics
- disinfectants and antiseptics
- vitamins and mineral supplements
- calling a therapeutic good or substance a vitamin, where you must only use certain permitted terms.
See examples in the table below.
| Product | Representations |
|---|---|
| Analgesics |
|
| Antiseptics and disinfectants | Representations that:
Representations about the:
Representations that refer to the:
Representations that:
|
| Vitamins or minerals | Representations about the:
Representations that vitamin products are:
|
A complete list of prohibited representations is in Part 1 of Schedule 2 of the Therapeutic Goods Regulations 1990.
List of approved restricted and prohibited representations
We publish permissions and approvals granted for both restricted and prohibited representations at Advertising permissions.