Restricted representations

What is a restricted representation?

A restricted representation is any reference expressly or by implication, to a disease, condition, ailment or defect specified in Table 1, Appendix 6 of the Therapeutic Goods Advertising Code (TGAC) <http://www.comlaw.gov.au>.

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

Sponsors wishing to make restricted representations on their label, are required to submit a formal application to the Secretary applying for an 'exemption' in order to allow the restricted representation. This is covered under Section 42DK of the Therapeutic Goods Act 1989 (the Act).

If the sponsor then wishes to use the restricted representation in advertising, then a separate application is required. This should be made on the form Application for approval to use a restricted representation in advertising <http://www.tga.gov.au/advert/forms/form-restrep.htm> and completed in conjunction with the related guidance document.

In summary, the relevant sections of the Act provide as follows:

LABEL Section 42DK - Use of restricted or prohibited representation

• Section 42DK gives provision for the Secretary to:
  • permit, in relation to therapeutic goods, the use of a restricted or prohibited representation (including its use on the label of goods or in information included in the package in which the goods are contained).
• Granting an exemption under Section 42DK will permit the indications to appear on the package labels and/ or on information contained with in the packaging, but does not extend to advertising.

ADVERTISEMENTS Section 42DE - Approval of use of restricted representation

• Requests for exemptions to allow sponsors to make reference to restricted representations in advertising, need to be submitted to the Delegate of the Secretary under Section 42DE.
• Section 42DE stipulates that the Secretary:
  1. must approve an application to use a restricted representation if the Secretary is satisfied that:
     1. the representation is accurate and balanced, and
     2. the representation is not misleading or likely to be misleading.
  2. Otherwise the Secretary must refuse to approve the use of the restricted representation.
  3. An approval may be subject to conditions imposed by the Secretary, and
  4. In deciding whether to approve or refuse to approve the use of a restricted representation, the Secretary must take into consideration:
     1. any recommendation of the Therapeutic Goods Advertising Code Council (TGACC);
     2. any advice of the Complementary Medicines Evaluation Committee (MEC) or the Medicines Evaluation Committee (CMEC);
     3. the public interest criteria mentioned in Part 2 of Appendix 6 of the Therapeutic Goods Advertising Code

For information regarding submissions to the Therapeutic Goods Advertising Code Council (TGACC) please refer to their website <http://www.tgacc.com.au>.

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