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The Code

Guide to the Advertising of Non-prescription Medicines to Consumers


Restricted Representations

Guidelines for the Levels and Kinds of Evidence to Support Claims for Therapeutic Goods

Industry Codes


(Section 5 refers)

Prohibited, Restricted and Permissible Representations

Part 1 – Prohibited Representations

A prohibited representation is defined as:
(i)    Any representation regarding abortifacient action
(ii) Any representation regarding the treatment, cure or prevention of the following diseases:

  • Neoplastic
  • Sexually Transmitted Diseases (STD)
  • HIV AIDS and/or HCV
  • Mental illness

Except for the following representations which are to become restricted representations:
(i)  prevention of skin cancer through the use of sunscreens
(ii)  devices used in contraception or in the prevention of transmission of disease between persons

Part 2 – Restricted Representations

An advertisement for Therapeutic Goods may refer, expressly or by implication, to a disease, condition, ailment or defect specified in Table 1, provided that prior approval is obtained for such a referenceApproval may be obtained from the TGA, upon recommendation from the TGACC and appropriate expert committee or committees.

Table 1.  Diseases, conditions, ailments and defects for which the advertising of serious forms is restricted

  • Cardiovascular diseases
  • Dental and periodontal diseases
  • Diseases of joint, bone, collagen, and rheumatic disease
  • Diseases of the eye or ear likely to lead to blindness or deafness
  • Diseases of the liver, biliary system or pancreas
  • Endocrine diseases and conditions including diabetes and prostatic disease
  • Gastrointestinal diseases or disorders
  • Haematological diseases
  • Infectious diseases
  • Immunological diseases
  • Mental disturbances
  • Metabolic disorders
  • Musculo-skeletal diseases
  • Nervous system diseases
  • Poisoning, venomous bites and stings
  • Renal diseases
  • Respiratory diseases
  • Skin diseases
  • Substance dependence
  • Urogenital diseases and conditions

Serious in the context of this table will mean forms of those diseases, conditions, ailments or defects which are:

  • Generally accepted not to be appropriate to be diagnosed and/or treated without consulting a suitably qualified healthcare professional, and/or
  • Generally accepted to be beyond the ability of the average consumer to evaluate accurately and to treat safely without regular supervision by a qualified healthcare professional.

Public interest criteria to be applied by TGACC

In considering an application for approval to include in an advertisement a reference to a disease, condition, ailment or defect specified in Part 2 of Appendix 6, the Secretary must consult the TGACC.  In making a recommendation to the Secretary, the TGACC must take into account:

1.       Consumers’, or certain groups of consumers’, vulnerability when faced with the disease, condition, ailment or defect;

2.      Whether the reference would be likely to result in consumers not seeking timely professional advice where appropriate (such as where timely professional advice is important to prevent negative health consequences or irrevocable deterioration or progression of disease);

3.      Whether the reference would be likely (alone or through repetition or together with other references) to have a negative impact on public health (or to have an effect on persons other than those to whom the advertisement is directed); and

4.      Such other aspects of the public interest as may appear to be appropriate.

5.      The World Health Organization notes that responsible self-medication can:

  • Help prevent and treat symptoms and ailments that do not require medical consultation;
  • Reduce the increasing pressure on medical services for the relief of minor ailments, especially when financial and human resources are limited;
  • Increase the availability of health care to populations living in rural or remote areas where access to medical advice may be difficult; and
  • Enable patients to control their own chronic conditions.

Additional Note: If this were to apply to products that require prescribing following initial diagnosis, the Code would apply to the advertising of such products.

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