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Restricted representations

13 September 2011

An advertisement for therapeutic goods may only refer, expressly or by implication, to a restricted representation if prior approval is obtained for such a reference.

Approval may be obtained from the TGA, which is required to consider any recommendation from the Therapeutic Goods Advertising Code Council (TGACC) or appropriate expert committee or committees.

What is a restricted representation?

A restricted representation is any reference expressly or by implication, to a serious disease, condition, ailment or defect which is generally accepted to be:

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

The list of restricted representations is specified in Table 1, Appendix 6 of the Therapeutic Goods Advertising Code (the Code):

• 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

Using restricted representations

Advertising (including labelling)

If a sponsor wishes to make reference to a restricted representation in advertising, including on its labels, then a formal application to the Delegate of the Secretary is required (Section 42DE of the Therapeutic Goods Act 1989 (the Act) refers, see below extract). This request must be made on the form 'Application for approval to use a restricted representation in advertising'. It may be completed in conjunction with the related guidance document.

Relevant sections of the Act

SECTION 3 - Definitions

• advertisement, in relation to therapeutic goods, includes any statement, pictorial representation or design, however made, that is intended, whether directly or indirectly, to promote the use or supply of the goods.
• label, in relation to therapeutic goods, means a display of printed information
  1. on or attached to the goods; or
  2. on or attached to a container or primary pack in which the goods are supplied; or
  3. supplied with such a container or pack.

ADVERTISEMENTS (including labels)

Section 42DE - Applications for approval of use of restricted representation

• An application for approval of the use of a restricted representation must be:
  1. made to the Secretary in writing, in a form approved by the Secretary; and
  2. signed by or on behalf of the applicant.

Section 42DF - Approval of use of restricted representation

• Section 42DF stipulates that:
  1. The Secretary 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 Advisory Committee on Complementary Medicines or the Advisory Committee on Non-prescription Medicines;
     3. the public interest criteria mentioned in Part 2 of Appendix 6 of the Code.

Section 42DK - Use of restricted or prohibited representation

• Section 42DK(1) allows the Secretary to permit the use of a restricted representation (including its use on the label of goods or in information included in the package in which the goods are contained).
• However, under Section 42DK(2), the Secretary may only permit a prohibited representation to be included on the label of therapeutic goods or in information included in the package in which therapeutic goods are contained, if the representation is necessary for the appropriate use of the goods.

Further information

For information on the TGACC, please refer to its website.

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